Drugs / Dapagliflozin
Dapagliflozin
also known as
DAPA · Forxiga · Farxiga · dapagliflozine · BMS -512148 · Dapagliflozin propanediol · A51R1 · ATB-1012 · +10 more
Small molecule targets OTUD1, SLC5A2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed symptomatic heart failure 1 milestone | |||||
| Filed | US (FDA) | Farxiga | symptomatic heart failure | 2020-01-06 | “FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk” astrazeneca.com ↗ |
| Filed type 1 diabetes mellitus 2 milestones | |||||
| Rejected (CRL) | US (FDA) | Farxiga | type 1 diabetes mellitus | 2019-07-15 | “complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin” astrazeneca.com ↗ |
| Filed | EU (EMA) | Forxiga | type 1 diabetes mellitus | 2018-03-05 | “European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin)” astrazeneca.com ↗ |
| Filed type 2 diabetes mellitus 5 milestones | |||||
| Rejected (CRL) | US (FDA) | — | type 2 diabetes mellitus | 2015-10-16 | “the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the investigational fixed-dose combination of...” astrazeneca.com ↗ “In response to the FDA’s January 2012 complete response letter requesting additional data to allow a better assessment of the benefit-risk profile of dapagliflozin” astrazeneca.com ↗ |
| Filed | US (FDA) | Forxiga | type 2 diabetes mellitus | 2013-07-25 | “acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes.” bms.com ↗ “the US Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin” astrazeneca.com ↗ “A resubmission of the New Drug Application (NDA) for dapagliflozin was accepted for review by the U.S. Food and Drug Administration (FDA) in July 2013” astrazeneca.com ↗ “The company and its partner AstraZeneca resubmitted to the FDA the New Drug Application for Forxiga for the treatment of adults with type 2 diabetes.” bms.com ↗ “submission of a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the EMA for dapagliflozin” bms.com ↗ “they have resubmitted to the U.S. Food and Drug Administration (FDA), a New Drug Application (NDA) for dapagliflozin” astrazeneca.com ↗ “the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for dapagliflozin” astrazeneca.com ↗ “A New Drug Application (NDA) for dapagliflozin was accepted for review by the FDA in March 2011.” bms.com ↗ “The New Drug Application for Forxiga (dapagliflozin) was filed with the US FDA in July 2013.” astrazeneca.com ↗ “The NDA and MAA submissions for dapagliflozin were filed in December 2010.” astrazeneca.com ↗ “The NDA and MAA submissions for dapagliflozin were filed in December 2010.” bms.com ↗ |
| Filed | Japan (PMDA) | Forxiga | type 2 diabetes mellitus | — | “In March, the Japanese Ministry of Health, Labor and Welfare also accepted for review the regulatory submission for Forxiga for the treatment of type 2 diabetes.” bms.com ↗ |
| Filed | China (NMPA) | Forxiga | type 2 diabetes mellitus | — | “In January, China’s State Food and Drug Administration accepted for review the regulatory submission for Forxiga for the treatment of type 2 diabetes.” bms.com ↗ |
| Filed | EU (EMA) | — | type 2 diabetes mellitus | — | “submission of a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the EMA for dapagliflozin” bms.com ↗ “A Marketing Authorisation Application (MAA) for dapagliflozin has also been validated by the European Medicines Agency (EMA).” astrazeneca.com ↗ “The NDA and MAA submissions for dapagliflozin were filed in December 2010.” bms.com ↗ “The NDA and MAA submissions for dapagliflozin were filed in December 2010.” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (8) | US (FDA) | FARXIGA | — | 2015-03-11 – 2024-06-12 | fda.gov ↗ |
| Approved | US (FDA) | FARXIGA | — | 2014-01-08 | fda.gov ↗ |
| Approved | EU (EMA) | Forxiga | — | 2012-11-11 | europa.eu ↗ |
Trials 427 · started per year
today
EU approved 2012
US approved 2014
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07235280 | Dec 2025 → Jun 2028 expected | lung adenocarcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 0 | NCT06373523 | Sep 2024 → Jun 2025 overdue | NAFLD1, fibrotic liver disease | Post Graduate Institute of Medical Education and Research, Chandigarh | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06812429 | May 2024 → Apr 2025 | — | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 0 | NCT05262257 | Apr 2022 → Dec 2023 | type 2 diabetes mellitus | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 164 trials · 5 met primary | ||||||
| Phase 1 | NCT07754331 | Aug → Dec 2026 expected | kidney failure | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1 | NCT07396844 | Jun 2026 | — | LG Chem | Completed | No outcome recorded |
| Phase 1 | NCT07590466 | May → Jul 2026 overdue | hypertensive disorder, type 2 diabetes mellitus | Autotelicbio | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07404137 | Feb → Apr 2026 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT07399470 | Jan → Feb 2026 overdue | — | LG Chem | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07333742 | Sep → Nov 2025 | — | LG Chem | Completed | No outcome recorded |
| Phase 1 | NCT07034781 | Aug → Nov 2025 overdue | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07044765 | Aug → Nov 2025 overdue | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07083401 | Jul 2025 → Jul 2026 overdue | diabetes mellitus | Boryung Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT07083388 | Jul 2025 → Jul 2026 overdue | diabetes mellitus | Boryung Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06979388 | May → Jul 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06831864 | Feb → May 2025 | symptomatic heart failure | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT06612086 | Oct 2024 → Sep 2025 overdue | pulmonary hypertension | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06651021 | Oct 2024 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05989347 | Oct 2024 → Dec 2027 expected | Her2-receptor negative breast cancer, hyperinsulinism | Yale University | Recruiting | No outcome recorded |
| Phase 1 | NCT06233045 | Jul → Aug 2024 | — | Bio-innova Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT04887935 | Jun 2024 → Nov 2025 | prostate carcinoma | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT06063109 | Oct → Nov 2023 | hypertensive disorder, type 2 diabetes mellitus | THPharm Corp. | Completed | No outcome recorded |
| Phase 1 | NCT05762952 | Jun 2023 → Aug 2025 overdue | myocardial ischemia | University of Virginia | Recruiting | No outcome recorded |
| Phase 1 | NCT05521984 | Apr 2023 → Mar 2031 expected | brain cancer, childhood malignant neoplasm | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT05453786 | Jun → Aug 2022 | — | SK Chemicals Co., Ltd. | Completed | Met primary |
| Phase 1 | NCT05429593 | Jun 2022 → Mar 2023 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT04234867 | May → Aug 2022 | diabetic ketoacidosis, type 1 diabetes mellitus | Kinderkrankenhaus auf der Bult | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT06165965 | May → Jun 2022 | — | Jeil Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 1 | NCT05411965 | Apr → Jul 2022 | type 2 diabetes mellitus | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05105698 | Jan → Feb 2022 | — | LG Chem | Unknown | No outcome recorded |
| Phase 1 | NCT05403281 | Nov → Dec 2021 | — | Dong Wha Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05236998 | Nov → Dec 2021 | — | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04991571 | Jul → Oct 2021 | chronic kidney disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04798222 | Jun → Sep 2021 | heart failure | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04542291 | Feb → Dec 2021 | malignant pancreatic neoplasm | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT04544319 | Oct 2020 → Mar 2021 | type 2 diabetes mellitus | LG Chem | Unknown | No outcome recorded |
| Phase 1 | NCT04972539 | Aug → Nov 2020 | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05066516 | Jun → Aug 2020 | diabetes mellitus | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04084184 | Mar 2019 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT03826641 | Feb → Mar 2019 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT03766724 | Nov 2018 → Jan 2019 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03704818 | Oct 2018 → Jun 2021 | type 1 diabetes mellitus | University of California, San Diego | Completed | No outcome recorded |
| Phase 1 | NCT03616392 | Jul → Sep 2018 | type 2 diabetes mellitus | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT03601910 | Jul → Sep 2018 | type 2 diabetes mellitus | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT03565458 | Apr → Aug 2018 | type 2 diabetes mellitus | LG Chem | Unknown | No outcome recorded |
| Phase 1 | NCT03364985 | Dec 2017 → May 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03169959 | May → Aug 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT02987738 | Feb → Dec 2017 | type 1 diabetes mellitus | Kinderkrankenhaus auf der Bult | Completed | No outcome recorded |
| Phase 1 | NCT02696941 | Feb 2016 → Apr 2018 | NAFLD1 | University of Oxford | Completed | No outcome recorded |
| Phase 1 | NCT02582840 | Oct 2015 → Jun 2016 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02325206 | Dec 2014 → Dec 2015 | type 1 diabetes mellitus | Kinderkrankenhaus auf der Bult | Completed | No outcome recorded |
| Phase 1 | NCT01877889 | Jul 2013 → Mar 2014 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT01535677 | Apr → Jul 2013 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01662999 | Aug → Nov 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01525238 | Jul 2012 → Sep 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01156246 | Jun → Aug 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01135446 | May → Jun 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01068756 | Mar → Apr 2010 | type 2 diabetes mellitus | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT01072578 | Feb → Apr 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01055652 | Jan → Apr 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01055691 | Jan → Apr 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01002807 | Nov → Dec 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00908271 | Jul → Aug 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00562250 | May → Aug 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00538174 | Nov 2007 → May 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00546741 | Nov 2007 → Feb 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00688493 | Jul 2007 → Apr 2008 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00554450 | Mar 2006 → Oct 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07678203 | May 2026 → Jan 2027 expected | chronic kidney disease, lupus nephritis, systemic lupus erythematosus | Hospital Civil Juan I. Menchaca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05719714 | Jan 2024 → Sep 2026 overdue | chronic kidney disease, diastolic heart failure | Northwestern University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06113900 | Dec 2023 → Dec 2024 | lupus nephritis | Ain Shams University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04401904 | Jun 2020 → Sep 2022 | — | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 1/2 | NCT03801642 | Jan 2019 → Jul 2022 | Alzheimer disease | Jeff Burns, MD | Completed | No outcome recorded |
| Phase 266 trials · 10 met primary · 3 missed | ||||||
| Phase 2 | NCT07864688 | Dec 2026 → Dec 2027 expected | rheumatoid arthritis | Al-Azhar University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07682350 | Sep 2026 → Sep 2029 expected | diabetes mellitus | Odense University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07516847 | Sep 2026 → Jan 2029 expected | anemia, myelodysplastic syndrome | Seug yun Yoon, MD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07310433 | Jun 2026 → Oct 2029 expected | metastatic prostate carcinoma | Yung NA | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07273838 | Mar 2026 → Aug 2028 expected | acute kidney injury, heart failure | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06072326 | Jan 2026 → Dec 2027 expected | diabetic kidney disease | University Medical Center Groningen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07222917 | Dec 2025 → Dec 2026 expected | chronic kidney disease | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07174687 | Dec 2025 → Dec 2027 expected | diffuse secondary choroid atrophy, retinal degeneration | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06762964 | May 2025 → Feb 2027 expected | congenital cardiovascular shunt, diastolic heart failure, univentricular cardiopathy | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT07018622 | May 2025 → Sep 2026 overdue | cancer, cisplatin toxicity | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Recruiting | No outcome recorded |
| Phase 2 | NCT06929169 | May 2025 → Jul 2026 overdue | end stage renal failure | Maximo Agustin Schiavone | Recruiting | No outcome recorded |
| Phase 2 | NCT06626737 | Apr → Dec 2025 overdue | acute graft versus host disease | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT06919523 | Apr → Aug 2025 overdue | — | Mansoura University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06897605 | Apr → Oct 2025 overdue | anemia due to chronic disorder, chronic kidney disease | Mansoura University | Recruiting | No outcome recorded |
| Phase 2 | NCT06887062 | Mar 2025 → Jul 2027 expected | Takayasu arteritis, temporal arteritis | University of Edinburgh | Recruiting | No outcome recorded |
| Phase 2 | NCT06845163 | Feb 2025 → Mar 2026 overdue | diabetic macular edema | Alexandria University | Recruiting | No outcome recorded |
| Phase 2 | NCT07245069 | Feb 2025 → Nov 2028 expected | breast cancer, chemotherapy-induced toxicity, heart failure | University Medical Centre Ljubljana | Recruiting | No outcome recorded |
| Phase 2 | NCT06748105 | Dec 2024 → Dec 2025 overdue | hyperglycemia | Lauro Fabián Amador Medina | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06528405 | Nov 2024 → Jul 2027 expected | acute kidney injury | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07555106 | Sep 2024 → Sep 2026 overdue | — | University of Guadalajara | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05833958 | Sep 2024 → Sep 2025 | type 2 diabetes mellitus | George Medicines PTY Limited | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06420167 | Jul 2024 → Apr 2027 expected | AL amyloidosis | Barbara Ann Karmanos Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06111768 | May 2024 → May 2026 overdue | cardio-renal syndrome | Yale University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06350123 | May 2024 → May 2025 | chronic kidney disease | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT06269484 | Feb → Dec 2024 | cirrhosis of liver | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT05914857 | Dec 2023 → Jun 2025 | glucose intolerance, prediabetes syndrome | Yangjin | Unknown | No outcome recorded |
| Phase 2 | NCT04640493 | Dec 2023 → Aug 2025 | heart failure, sleep apnea syndrome | Columbia University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05938712 | Oct 2023 → Oct 2027 expected | disease related to solid organ transplantation | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06341842 | Oct 2023 → Apr 2025 | breast cancer | Fondazione IRCCS Policlinico San Matteo di Pavia | Unknown | No outcome recorded |
| Phase 2 | NCT05058859 | Sep 2023 → Oct 2024 | cystinuria | University of California, San Francisco | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05710367 | Aug 2023 → Aug 2024 | Fabry disease | Albina Nowak, MD | Unknown | No outcome recorded |
| Phase 2 | NCT05884866 | Jul 2023 → Dec 2025 | chronic renal failure syndrome, disorder of acid-base balance | Klinikum Nürnberg | Completed | No outcome recorded |
| Phase 2 | NCT06155604 | Jan 2023 → Dec 2026 expected | chronic kidney disease, lupus nephritis | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2 | NCT05516498 | Oct 2022 → May 2025 | cirrhosis of liver | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04930549 | Oct 2022 → Sep 2024 | chronic kidney disease | University Hospital, Rouen | Completed | No outcome recorded |
| Phase 2 | NCT05570305 | Oct 2022 → Mar 2025 | chronic kidney disease | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT05179668 | Oct 2022 → Jul 2025 | chronic kidney disease, heart disorder, kidney failure, type 2 diabetes mellitus | Medical University of Vienna | Completed | No outcome recorded |
| Phase 2 | NCT04782245 | Sep 2022 → Apr 2024 | advanced heart failure | Hospices Civils de Lyon | Withdrawn | No outcome recorded |
| Phase 2 | NCT05254626 | Aug 2022 → Jan 2024 | metabolic dysfunction-associated steatohepatitis | Cairo University | Completed | No outcome recorded |
| Phase 2 | NCT05420285 | Jun 2022 → Sep 2023 | heart failure | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2 | NCT05330013 | Jun 2022 | heart failure, myocardial disorder | National Heart, Lung, and Blood Institute (NHLBI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT05359263 | Jun 2022 → Feb 2025 overdue | chronic kidney disease | Tor Biering-Sørensen | Recruiting | Met primary |
| Phase 2 | NCT04899349 | Apr 2022 → May 2023 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05250752 | Nov 2021 → Feb 2022 | end stage renal failure | Holbaek Sygehus | Unknown | No outcome recorded |
| Phase 2 | NCT04794517 | Nov 2021 → May 2024 | chronic kidney disease | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 2 | NCT04818034 | Aug → Dec 2021 | cystinuria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT05025735 | Aug 2021 → Dec 2022 | Her2-receptor negative breast cancer | Saint Luke's Health System | Unknown | No outcome recorded |
| Phase 2 | NCT04724837 | Apr 2021 → Jun 2023 | chronic kidney disease | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT04730947 | Feb 2021 → Nov 2022 | diastolic heart failure | Mayo Clinic | Completed | Met primary |
| Phase 2 | NCT04595370 | Jan 2021 → Sep 2023 | chronic kidney disease, heart failure | AstraZeneca | Completed | Missed primary |
| Phase 2 | NCT04304560 | Mar 2020 → Mar 2021 | cardiomyopathy, systolic heart failure, type 2 diabetes mellitus | Damanhour University | Unknown | No outcome recorded |
| Phase 2 | NCT04258371 | Feb 2020 → Dec 2023 | — | University Health Network, Toronto | Unknown | Met primary |
| Phase 2 | NCT04419337 | Sep 2019 → Jul 2023 | diabetes mellitus, stroke disorder | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03190694 | Nov 2017 → Nov 2019 | chronic kidney disease, proteinuria | Hiddo Lambers Heerspink | Completed | Missed primary |
| Phase 2 | NCT03316131 | Oct 2017 → Jul 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT03180489 | May 2017 → Dec 2018 | — | Christopher Bell | Completed | No outcome recorded |
| Phase 2 | NCT02695810 | Feb 2016 → Sep 2018 | obesity disorder, prediabetes syndrome | Steno Diabetes Center Copenhagen | Completed | Met primary |
| Phase 2 | NCT02520518 | Aug 2015 → May 2017 | — | Christopher Bell | Terminated | No outcome recorded |
| Phase 2 | NCT02371187 | Jun 2015 → Jan 2018 | — | Christopher Bell | Completed | No outcome recorded |
| Phase 2 | NCT02279407 | Jan → Dec 2015 | NAFLD1 | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT02313220 | Dec 2014 → Mar 2016 | obesity disorder | Uppsala University | Completed | No outcome recorded |
| Phase 2 | NCT01498185 | Feb → Oct 2012 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00976495 | Oct 2009 → Nov 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 2 | NCT00972244 | Aug 2009 → May 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00831779 | Apr 2009 → Aug 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00263276 | Dec 2005 → Feb 2007 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 2/318 trials · 4 met primary | ||||||
| Phase 2/3 | NCT07684326 | Jul 2026 → Jul 2027 expected | — | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07214818 | Nov 2025 → Jul 2026 overdue | nephrotic syndrome | Mansoura University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07033585 | Jun 2025 → Oct 2026 expected | type 2 diabetes mellitus | Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT06783166 | Aug 2024 → Jul 2025 overdue | heart failure | Mansoura University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06111443 | Dec 2023 → Nov 2026 expected | atrial fibrillation | Chang Gung Memorial Hospital | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05713851 | Jan 2023 → Dec 2024 | acute kidney injury, chronic kidney disease | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Unknown | No outcome recorded |
| Phase 2/3 | NCT05676684 | Sep 2022 → Nov 2024 | diastolic heart failure | University of Porto | Completed | Met primary |
| Phase 2/3 | NCT05406505 | Apr 2022 → May 2023 | heart failure | Mansoura University | Completed | Met primary |
| Phase 2/3 | NCT06286878 | Dec 2021 → Jul 2025 overdue | acute coronary syndrome, cardiac ventricle disorder, diabetes mellitus, myocardial infarction | University of Sao Paulo | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04764097 | Jun 2021 → Jun 2025 | cardiovascular disorder, end stage renal failure | Tan Tock Seng Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT05565976 | Aug 2020 → Dec 2024 | cognitive impairment with or without cerebellar ataxia, ischemic stroke, metabolic syndrome X, vascular dementia | Jaime Daniel Mondragon | Unknown | No outcome recorded |
| Phase 2/3 | NCT04393246 | Jul 2020 → Jun 2022 | COVID-19 | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2/3 | NCT04400760 | May 2020 → Jun 2022 | platelet disorder, undefined | The University of The West Indies | Completed | No outcome recorded |
| Phase 2/3 | NCT03899402 | May 2019 → Jan 2026 overdue | type 1 diabetes mellitus | State University of New York at Buffalo | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03968224 | Aug 2018 → Jul 2024 | morbid obesity, prediabetes syndrome, type 2 diabetes mellitus | Centro Medico Nacional Siglo XXI IMSS | Completed | No outcome recorded |
| Phase 2/3 | NCT02547935 | Sep 2015 → May 2018 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 2/3 | NCT02113241 | Apr 2014 → May 2015 | metabolic syndrome X | University of Guadalajara | Completed | No outcome recorded |
| Phase 2/3 | NCT00357370 | Oct 2006 → Mar 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3103 trials · 41 met primary · 6 missed | ||||||
| Phase 3 | NCT06907251 | Sep 2026 → Jun 2028 expected | COVID-19, long COVID-19 | Ottawa Heart Institute Research Corporation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07569640 | Aug 2026 → Apr 2029 expected | symptomatic heart failure | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT07662044 | Jul 2026 → Jul 2028 expected | type 2 diabetes mellitus | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07662109 | Jul 2026 → Jul 2028 expected | type 2 diabetes mellitus | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07056699 | Jul 2026 → Jun 2027 expected | type 1 diabetes mellitus | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
| Phase 3 | NCT07488689 | Jul 2026 → Aug 2029 expected | infectious disease with sepsis | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07598864 | May 2026 → May 2027 expected | diabetic kidney disease | Chittagong Medical College | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06405178 | Mar 2026 | polycystic ovary syndrome | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT07297589 | Dec 2025 → Jan 2027 expected | ST-elevation myocardial infarction | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT07295223 | Dec 2025 → Aug 2026 overdue | ST-elevation myocardial infarction | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT07280585 | Dec 2025 → May 2030 expected | autosomal dominant polycystic kidney disease | University of Cologne | Recruiting | No outcome recorded |
| Phase 3 | NCT07105917 | Aug 2025 → Aug 2026 overdue | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07026968 | Jun 2025 → Oct 2026 expected | type 2 diabetes mellitus | CSPC Ouyi Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07187570 | Jun 2025 → Dec 2027 expected | atrial fibrillation | Region Stockholm | Recruiting | No outcome recorded |
| Phase 3 | NCT06982079 | May 2025 → Jun 2026 overdue | end stage renal failure | Ain Shams University | Recruiting | No outcome recorded |
| Phase 3 | NCT06647745 | Apr 2025 → Jun 2026 overdue | hypertensive disorder, type 2 diabetes mellitus | THPharm Corp. | Recruiting | No outcome recorded |
| Phase 3 | NCT06890143 | Mar 2025 → Dec 2026 expected | inherited kidney disorder | Children's Hospital of Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT06759077 | Feb 2025 → Mar 2026 | kidney disorder | Al-Azhar University | Completed | No outcome recorded |
| Phase 3 | NCT07356388 | Jan 2025 → Oct 2027 expected | disease related to solid organ transplantation, proteinuria | kewen Chen,MD | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06174753 | Jan 2025 → Jun 2027 expected | ST-elevation myocardial infarction | Ottawa Heart Institute Research Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06750458 | Jan 2025 → Sep 2026 | glioma | Tanta University | Completed | No outcome recorded |
| Phase 3 | NCT06434025 | May 2024 → May 2026 overdue | iron metabolism disease, systolic heart failure | Hospital de Clinicas de Porto Alegre | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06772168 | Apr 2024 → Nov 2026 expected | hyperlipidemia, type 2 diabetes mellitus | CMG Pharmaceutical Co. Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06304857 | Apr 2024 → Dec 2026 expected | breast cancer, heart failure | 4th Military Clinical Hospital with Polyclinic, Poland | Recruiting | No outcome recorded |
| Phase 3 | NCT05944016 | Mar 2024 → Sep 2026 overdue | chronic renal failure syndrome | University Hospital Goettingen | Recruiting | No outcome recorded |
| Phase 3 | NCT06711185 | Jan 2024 → Jan 2026 overdue | breast cancer | University of Campinas, Brazil | Recruiting | No outcome recorded |
| Phase 3 | NCT05468203 | Nov 2023 → Jul 2025 | acute kidney injury | The George Institute | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT06117137 | Nov 2023 → Jan 2025 | NAFLD1 | Sohag University | Completed | No outcome recorded |
| Phase 3 | NCT05764057 | Jun 2023 → Oct 2026 expected | ST-elevation myocardial infarction | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05849766 | Apr 2023 → May 2024 | dilated cardiomyopathy | October 6 University | Completed | No outcome recorded |
| Phase 3 | NCT05345327 | Jan 2023 → Jun 2026 overdue | type 2 diabetes mellitus | The George Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05618223 | Dec 2022 → May 2023 | heart failure, mitral valve stenosis, rheumatic heart disease | Universitas Sebelas Maret | Unknown | No outcome recorded |
| Phase 3 | NCT05374291 | Nov 2022 → Jul 2027 expected | chronic kidney disease, heart failure, kidney failure | University Medical Center Groningen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06142474 | Oct 2022 → Oct 2030 expected | heart failure, ventilation pneumonitis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05505994 | Sep 2022 → Feb 2024 | type 2 diabetes mellitus | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT07344922 | Sep 2022 → Nov 2023 | anemia, calcinosis, chronic kidney disease | Mansoura University | Completed | No outcome recorded |
| Phase 3 | NCT05310916 | Jun 2022 → May 2023 | diabetic retinopathy | Nidae Alaa | Unknown | No outcome recorded |
| Phase 3 | NCT05196347 | May 2022 → Aug 2024 | chronic kidney disease | Kaohsiung Medical University | Completed | No outcome recorded |
| Phase 3 | NCT04965935 | Jul 2021 → Aug 2024 | disease related to solid organ transplantation, type 2 diabetes mellitus | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 3 | NCT05998525 | Jun 2021 → Dec 2022 | intermediate coronary syndrome, myocardial infarction, type 2 diabetes mellitus | Hilda Elizabeth Macías Cervantes | Completed | Missed primary |
| Phase 3 | NCT06619600 | May 2021 → Mar 2025 overdue | ST-elevation myocardial infarction, diabetes mellitus, heart failure | Hospital Clinic of Barcelona | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04860011 | Apr 2021 → Oct 2022 | heart failure | NHS Greater Glasgow and Clyde | Unknown | Missed primary |
| Phase 3 | NCT06329674 | Apr 2021 → Dec 2022 | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04707352 | Feb 2021 → Mar 2023 | heart failure | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | Met primary |
| Phase 3 | NCT04564742 | Dec 2020 → Jul 2023 | acute myocardial infarction, heart failure | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT04333823 | Dec 2020 → May 2024 overdue | type 1 diabetes mellitus | The Hospital for Sick Children | Active not recruiting | Met primary |
| Phase 3 | NCT04255238 | Jun 2020 → May 2022 | type 2 diabetes mellitus | LG Chem | Unknown | No outcome recorded |
| Phase 3 | NCT04356742 | May 2020 → Feb 2022 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04298229 | Apr 2020 → May 2023 | heart failure, type 2 diabetes mellitus | Vanderbilt University Medical Center | Completed | Missed primary |
| Phase 3 | NCT05109949 | Mar 2020 → Jun 2022 | type 2 diabetes mellitus | Centro Universitario de Ciencias de la Salud, Mexico | Unknown | No outcome recorded |
| Phase 3 | NCT04213677 | Mar 2020 → Oct 2022 | polycystic ovary syndrome | Nanfang Hospital, Southern Medical University | Completed | No outcome recorded |
| Phase 3 | NCT04035031 | Jan → Nov 2020 | type 1 diabetes mellitus | Insel Gruppe AG, University Hospital Bern | Completed | Missed primary |
| Phase 3 | NCT04195243 | Dec 2019 → Jun 2020 | type 2 diabetes mellitus | Centro Universitario de Ciencias de la Salud, Mexico | Unknown | No outcome recorded |
| Phase 3 | NCT03877237 | Apr 2019 → Mar 2020 | systolic heart failure | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT03877224 | Apr 2019 → Jul 2020 | diastolic heart failure | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT03723252 | Mar 2019 → Mar 2024 | metabolic dysfunction-associated steatohepatitis | Nanfang Hospital, Southern Medical University | Completed | Met primary |
| Phase 3 | NCT03658031 | Mar 2019 → Dec 2020 | myocardial infarction, prediabetes syndrome, type 2 diabetes mellitus | Hamad Medical Corporation | Unknown | No outcome recorded |
| Phase 3 | NCT03794518 | Mar 2019 → Sep 2021 | — | Hamad Medical Corporation | Unknown | No outcome recorded |
| Phase 3 | NCT03608358 | Feb 2019 → Aug 2020 | type 2 diabetes mellitus | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03762850 | Dec 2018 → Aug 2023 overdue | IgA glomerulonephritis | Travere Therapeutics, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03619213 | Aug 2018 → Mar 2022 | diastolic heart failure | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT03419624 | Feb 2018 → Apr 2019 | obesity disorder, type 2 diabetes mellitus | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded |
| Phase 3 | NCT03313752 | Dec 2017 → Oct 2022 | coronary artery disorder, type 2 diabetes mellitus | Giaccari Andrea | Completed | No outcome recorded |
| Phase 3 | NCT03199053 | Oct 2017 → Feb 2023 | type 2 diabetes mellitus | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT03036124 | Feb 2017 → Jul 2019 | heart failure | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT03036150 | Feb 2017 → Jun 2020 | chronic kidney disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02946632 | Dec 2016 → Dec 2019 | type 2 diabetes mellitus | Korea University Anam Hospital | Unknown | Met primary |
| Phase 3 | NCT02725593 | Jun 2016 → Apr 2020 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02635386 | Mar 2016 → Jul 2020 | obesity disorder, polycystic ovary syndrome | Woman's | Completed | No outcome recorded |
| Phase 3 | NCT02582814 | Oct 2015 → Jun 2017 | type 1 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02551874 | Oct 2015 → May 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02532855 | Oct 2015 → Oct 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02419612 | Aug 2015 → Aug 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02460978 | Jul 2015 → Sep 2017 | type 1 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02413398 | Jun 2015 → Nov 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02268214 | Nov 2014 → Jan 2017 | type 1 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02284893 | Sep 2014 → Sep 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02229396 | Sep 2014 → Apr 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02096705 | Mar 2014 → Jan 2016 | diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01730534 | Apr 2013 → Sep 2018 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01646320 | Sep 2012 → Aug 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01606007 | Jul 2012 → Jan 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01257412 | Jan 2012 → Jun 2013 | type 2 diabetes mellitus | AstraZeneca | Suspended | No outcome recorded |
| Phase 3 | NCT01392677 | Oct 2011 → Jan 2013 | hyperglycemia, type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01294423 | Feb 2011 → Mar 2012 | hyperglycemia, type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01294436 | Feb 2011 → Sep 2012 | hyperglycemia, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01217892 | Nov 2010 → Aug 2011 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01195662 | Oct 2010 → Feb 2013 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01137474 | Jul 2010 → Feb 2013 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01095666 | Jun 2010 → Mar 2013 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01095653 | Jun 2010 → Mar 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01042977 | Mar 2010 → May 2011 | cardiovascular disorder, type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01031680 | Feb 2010 → May 2011 | hypertensive disorder, type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00859898 | Apr 2009 → May 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00855166 | Feb 2009 → Jun 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00736879 | Sep 2008 → Dec 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00683878 | Jul 2008 → Jan 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00643851 | Jun 2008 → Aug 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00680745 | Apr 2008 → Nov 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00673231 | Apr 2008 → May 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00660907 | Mar 2008 → Dec 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00528879 | Sep 2007 → Nov 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00528372 | Sep 2007 → Feb 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 4136 trials · 3 met primary · 8 missed | ||||||
| Phase 4 | NCT07848191 | Sep 2026 → Nov 2027 expected | metabolic dysfunction-associated steatohepatitis | Madrigal Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07342764 | Sep 2026 → Nov 2028 expected | — | Sultan Qaboos University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07631156 | Aug 2026 → Jun 2029 expected | left ventricular failure, symptomatic heart failure | Kyungsub Song | Recruiting | No outcome recorded |
| Phase 4 | NCT07572032 | May 2026 → May 2028 expected | coronary atherosclerosis, heart failure, intrinsic cardiomyopathy | Kyungsub Song | Recruiting | No outcome recorded |
| Phase 4 | NCT07405216 | Apr 2026 → May 2027 expected | chronic kidney disease, proteinuria | Centenario Hospital Miguel Hidalgo | Recruiting | No outcome recorded |
| Phase 4 | NCT07482943 | Apr 2026 → Apr 2028 expected | heart failure | The University of Hong Kong | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07513883 | Mar 2026 → Sep 2028 expected | heart failure | Ziekenhuis Oost-Limburg | Recruiting | No outcome recorded |
| Phase 4 | NCT07351643 | Feb → Oct 2026 expected | acute coronary syndrome | Shenyang Northern Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07614230 | Jan 2026 → Jun 2027 expected | atherosclerosis, coronary artery disorder, type 2 diabetes mellitus | Junjie Yang | Recruiting | No outcome recorded |
| Phase 4 | NCT07311551 | Dec 2025 → Dec 2026 expected | type 2 diabetes mellitus | Bhavya Bhavya, MD | Not yet recruiting | No outcome recorded |
| Show all 136 trials opens the full record — a long page | ||||||
| Phase not applicable31 trials · 1 missed | ||||||
| — | NCT07595289 | Aug → Dec 2026 expected | type 2 diabetes mellitus | The Third Xiangya Hospital of Central South University | Not yet recruiting | No outcome recorded |
| — | NCT07679828 | Jul 2026 → Dec 2029 expected | hyperlipidemia, hypertensive disorder, type 2 diabetes mellitus | China Medical University, China | Recruiting | No outcome recorded |
| — | NCT07491042 | Apr → Sep 2026 overdue | end stage renal failure | Oman Ministry of Health | Recruiting | No outcome recorded |
| — | NCT07392788 | Apr 2026 → Dec 2027 expected | symptomatic heart failure | Centre Hospitalier Universitaire de Besancon | Not yet recruiting | No outcome recorded |
| — | NCT07403955 | Feb 2026 → Dec 2027 expected | congestive heart failure | Qilu Hospital of Shandong University | Not yet recruiting | No outcome recorded |
| — | NCT07331727 | Jan → Sep 2026 overdue | atrial fibrillation | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07272057 | Dec 2025 → Oct 2026 expected | lung cancer | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07204743 | Aug 2025 → Jun 2026 overdue | proteinuria | Al-Quds University | Active not recruiting | No outcome recorded |
| — | NCT06740786 | Dec 2024 → May 2026 overdue | atrial fibrillation | Xu Liu | Not yet recruiting | No outcome recorded |
| — | NCT06719661 | Dec 2024 → May 2025 | type 2 diabetes mellitus | University of Sulaimani | Completed | No outcome recorded |
| — | NCT06433479 | Jul 2024 → Jul 2025 | atrial fibrillation | Beijing Anzhen Hospital | Completed | Missed primary |
| — | NCT06915870 | Jul 2024 → Jan 2025 | diabetes mellitus, heart failure | Fatima Maqsood | Completed | No outcome recorded |
| — | NCT06187493 | Jan 2024 → Jan 2025 | diabetic kidney disease | Assiut University | Unknown | No outcome recorded |
| — | NCT06147518 | Dec 2023 → Dec 2024 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT06091475 | Dec 2023 → Aug 2026 overdue | dilated cardiomyopathy, heart failure | Imperial College London | Recruiting | No outcome recorded |
| — | NCT05965440 | Nov 2023 → Feb 2026 | chronic kidney disease | Hospices Civils de Lyon | Completed | No outcome recorded |
| — | NCT06344247 | Sep 2023 → Sep 2025 | chronic kidney disease, obesity disorder | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT05849220 | May 2023 → Mar 2024 | cirrhosis of liver | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT07338331 | Apr 2023 → Apr 2025 | NAFLD1, type 2 diabetes mellitus | Galala University | Completed | No outcome recorded |
| — | NCT05390307 | Apr 2023 → Jan 2024 | type 1 diabetes mellitus | Dasman Diabetes Institute | Completed | No outcome recorded |
| — | NCT06065280 | Nov 2022 → Dec 2024 | heart failure | Damanhour University | Completed | No outcome recorded |
| — | NCT05795400 | Jun 2022 → May 2025 | amyloidosis, diastolic heart failure, mild heart failure | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | Completed | No outcome recorded |
| — | NCT07539584 | Mar 2022 → Apr 2024 | metabolic dysfunction-associated steatotic liver disease, type 2 diabetes mellitus | Moscow Regional Research and Clinical Institute (MONIKI) | Completed | No outcome recorded |
| — | NCT05141552 | Jan → Jul 2022 | — | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT04923295 | Jun → Jul 2021 | — | An-Najah National University | Completed | No outcome recorded |
| — | NCT04882358 | May 2021 → Aug 2022 | heart failure | Sequana Medical N.V. | Unknown | No outcome recorded |
| — | NCT04717986 | Jan 2021 → Jun 2022 | acute myocardial infarction, heart failure, intermediate coronary syndrome | Mexican Social Security Institute | Completed | No outcome recorded |
| — | NCT04591639 | Aug 2020 → Jan 2025 | cardiomyopathy, heart failure | University of Edinburgh | Completed | No outcome recorded |
| — | NCT03917758 | Oct 2018 → Jul 2020 | hypertensive disorder, type 2 diabetes mellitus | University of Turin, Italy | Unknown | No outcome recorded |
| — | NCT02420392 | Feb 2015 → Apr 2016 | type 2 diabetes mellitus | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT01439854 | Mar 2011 → Jun 2018 | — | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Comparator or background therapy187 trials | ||||||
| Phase 0 | NCT04780438 Comparator | Sep 2021 → Sep 2023 | atrial fibrillation | G.Gennimatas General Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT04806633 Comparator | Apr 2021 → Sep 2023 | acute kidney injury | G.Gennimatas General Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT06759909 Comparator | Jan 2025 → Dec 2026 expected | atrial fibrillation | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06639087 Comparator | Sep 2024 → May 2025 | heart failure, impaired renal function disease | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05217654 Comparator | Feb 2022 → Feb 2023 | vascular insufficiency disorder | Medical University of Vienna | Unknown | No outcome recorded |
| Show all 187 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 130
| Date | Issuer | Release |
|---|---|---|
| 2026-07-07 | Kailera | Results Kailera Therapeutics Announces Positive Topline Data from Two Hengrui Pharma Phase 3 Clinical Trials of Oral Small Molecule GLP-1 Receptor Agonist HRS-7535/KAI-7535 kailera.com ↗
At Week 32: Based on the efficacy estimand 3 , the reductions in HbA1c from baseline for the HRS-7535 30 mg, 60 mg, and 90 mg groups and the dapagliflozin 10 mg group were 1.58%, 1.50%, 1.68%, and 1.28%, respectively. |
| 2026-04-08 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Dapagliflozin Tablets, 5 mg and 10 mg zyduslife.com ↗
Zydus Lifesciences Limited (“Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga ® Tablets, 5 mg and 10 mg). |
| 2026-04-07 | Lupin Limited | Regulatory Lupin Announces the Approval of Dapagliflozin Tablets in the United States lupin.com ↗
The U.S. FDA has approved Lupin’s Dapagliflozin Tablets, 5 mg and 10 mg, as bioequivalent to Farxiga® for the indications in the approved labeling. |
| 2026-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory 7th April, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg. |
| 2026-02-04 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Dapagliflozin tablets zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga® Tablets, 5 mg and 10 mg). |
| 2025-12-29 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN, DAPAGLIFLOZIN AND METFORMIN EXTENDED-RELEASE TABLETS OBTAIN CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗ |
| 2025-10-15 | Eli Lilly and Company | Results Lilly's oral GLP-1, orforglipron, demonstrated superior glycemic control in two successful Phase 3 trials, reconfirming its potential as a foundational treatment in type 2 diabetes lilly.com ↗
In ACHIEVE-2, orforglipron lowered A1C by up to 1.7% compared to 0.8% with dapagliflozin, meeting the primary endpoint |
| 2024-07-12 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical Presented Superiority of Enavogliflozin at 84th ADA Scientific Sessions daewoong.co.kr ↗
After 24 weeks of treatment, 78.1% of patients on Enavogliflozin achieved an HbA1c level below 7%, compared to 65.7% for dapagliflozin. |
| 2024-06-12 | AstraZeneca | Regulatory Farxiga approved in the US for the treatment of paediatric type-2 diabetes astrazeneca.com ↗
AstraZeneca’s Farxiga (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in paediatric patients with type-2 diabetes (T2D) aged 10 years and older. |
| 2024-04-15 | Theracos | Results Head-to-Head Study Finds BRENZAVVY® (bexagliflozin) Non-Inferior to Dapagliflozin in Chinese Patients With Type 2 Diabetes theracosbio.com ↗
The study results demonstrated the noninferiority of BRENZAVVY® (bexagliflozin) to dapagliflozin, marketed as Farxiga in the United States, in patients with type 2 diabetes mellitus. |
| 2024-03-22 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - DAPAGLIFLOZIN TABLETS OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Dapagliflozin Tablets (5mg/10mg) (the “Product”) developed by the Group has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China, and is deemed to have passed the consistency evaluation of quality and efficacy for generic drugs. |
| 2023-11-21 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Dapagliflozin Tablets lupin.com ↗ |
| 2023-11-03 | AstraZeneca | Results Zibotentan/dapagliflozin combination demonstrated significant albuminuria reduction in patients with chronic kidney disease and proteinuria in ZENITH-CKD Phase IIb trial astrazeneca.com ↗
Combination of zibotentan with dapagliflozin showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), used to assess albuminuria, at 12 weeks compared with dapagliflozin alone. |
| 2023-10-04 | AstraZeneca | Results Forxiga met primary endpoint in T2NOW Phase III trial, one of the largest paediatric type 2 diabetes studies performed to date astrazeneca.com ↗
Positive results from the T2NOW Phase III trial demonstrated significant reduction in A1C, a marker of average blood sugar, for patients treated with Forxiga (dapagliflozin) compared with patients receiving placebo. |
| 2023-10-04 | Jeil Pharmaceutical Co., Ltd. | Regulatory 제일약품, 당뇨복합제 ‘듀글로우정’ 허가 획득 jeilpharm.co.kr ↗
제일약품(대표 성석제)이 식품의약품안전처로부터 당뇨 복합제인 ‘듀글로우정’에 대한 품목허가를 획득했다고 4일 밝혔다. |
| 2023-08-18 | AstraZeneca | Regulatory Forxiga approved in China to reduce the risk of cardiovascular death and hospitalisation in adult patients with symptomatic chronic heart failure astrazeneca.com ↗
Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. |
| 2023-05-09 | AstraZeneca | Regulatory Farxiga extended in the US to reduce risk of cardiovascular death and hospitalisation for heart failure to a broader range of patients astrazeneca.com ↗
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. |
| 2023-04-18 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 제2형 당뇨병 복합제 ‘슈가다파메트서방정’ 품목허가 신청 donga-st.com ↗
동아에스티(대표이사 사장 김민영)는 식품의약품안전처에 제2형 당뇨병 복합제 ‘슈가다파메트서방정’의 품목허가를 신청했다고 18일 밝혔다. |
| 2023-02-07 | AstraZeneca | Regulatory Forxiga approved in the EU for the treatment of symptomatic chronic heart failure astrazeneca.com ↗ |
| 2023-01-10 | Ono Pharmaceutical Co., Ltd. | Regulatory Revision of Electronic Package Insert of Forxiga, a Selective SGLT2 inhibitor, related to Indication of Chronic Heart Failure ono-pharma.com ↗
This revision of the electronic package insert allows Farxiga to be used as a treatment of patients with chronic heart failure regardless of left ventricular ejection fraction. |
| 2022-12-19 | AstraZeneca | Regulatory Forxiga recommended for approval in the EU by CHMP for symptomatic chronic heart failure astrazeneca.com ↗ |
| 2022-11-07 | AstraZeneca | Results Farxiga improved symptom burden and health-related quality of life in patients with mildly reduced or preserved ejection fraction in DELIVER Phase III trial astrazeneca.com ↗
In the analysis, Farxiga, in addition to standard care compared with placebo, improved symptom burden, physical limitations and quality of life as measured by mean KCCQ scores, with benefits achieved as early as one month 1 . |
| 2022-11-05 | AstraZeneca | Results AstraZeneca presents data at ASN Kidney Week 2022 reinforcing urgent need for early screening of chronic kidney disease and the benefits of earlier treatment initiation for patients and healthcare systems astrazeneca.com ↗
Findings from INSIDE-CKD demonstrate that Farxiga could cut 33 percent of healthcare costs by delaying disease progression and reducing incidence of cardiorenal events |
| 2022-09-05 | AstraZeneca | Regulatory Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes astrazeneca.com ↗
Approval marks the first SGLT2 inhibitor approved in China for chronic kidney disease in adult patients with and without type-2 diabetes |
| 2022-08-27 | AstraZeneca | Results New data show Farxiga significantly lowers the risk of cardiovascular death in patients with heart failure astrazeneca.com ↗
Today, new results from a pre-specified, patient level, pooled analysis from the Phase III DAPA-HF and DELIVER trials demonstrated mortality benefit of Farxiga (dapagliflozin), compared to placebo, in patients with heart failure (HF). |
| 2022-08-27 | AstraZeneca | Results Farxiga significantly reduced the risk of cardiovascular death or worsening of heart failure in patients with mildly reduced or preserved ejection fraction in DELIVER Phase III trial astrazeneca.com ↗
Farxiga reduced the composite outcome of CV death or worsening of HF by 18% (p<0.001, 16.4% in the dapagliflozin group and 19.5% in the placebo group over a median follow-up of 2.3 years). |
| 2022-07-29 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 제2형 당뇨병 복합제 ‘슈가다파정’ 품목허가 신청 donga-st.com ↗
동아에스티(대표이사 사장 김민영)는 식품의약품안전처에 제2형 당뇨병 복합제 ‘슈가다파정’의 품목허가를 신청했다고 29일 밝혔다. |
| 2022-05-05 | AstraZeneca | Results Farxiga met primary endpoint in DELIVER Phase III trial, reducing risk of cardiovascular death or worsening heart failure in patients with preserved ejection fraction astrazeneca.com ↗
High-level results from the DELIVER Phase III trial showed AstraZeneca’s Farxiga (dapagliflozin) reached a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular (CV) death or worsening heart failure (HF). |
| 2022-02-24 | Zydus Lifesciences Limited | Regulatory Zydus gets final approval for Dapagliflozin Tablets zyduslife.com ↗
Zydus has received final approval from the USFDA to market Dapagliflozin Tablets in the strengths of 5 mg and 10 mg (USRLD: Farxiga). |
| 2021-12-07 | LG Life Sciences | Results LG Chem finds ‘SOLUTION’ to maximize blood sugar lowering effects lgchem.com ↗
When ‘Zemiglo’ is added to patients taking ‘Metformin + Dapagliflozin’, blood sugar lowering effects and safety were identified, and superior effects compared to placebo were demonstrated |
| 2021-08-26 | Ono Pharmaceutical Co., Ltd. | Regulatory Forxiga Approved in Japan for the Treatment of Chronic Kidney Disease in Patients with and without Type-2 Diabetes Approval marks a significant progress in the treatment of patients suffering from chronic kidney disease in Japan PDF(252 KB) AstraZeneca K.K. (Osaka, Japan; President and Representative Director: Stefan Woxstrӧm) and Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director: Gyo Sagara) announced that Forxiga® (generic name: dapagliflozin propylene glycolate hydrate) Tablets 5mg, 10mg (“Forxiga”), an inhibitor of sodium-glucose co-transporter 2 (SGLT2), received an additional approval for the indication of “chronic kidney disease (excluding patients with end-stage renal disease or undergoing dialysis)” with and without type-2 diabetes on August 25, 2021. The approval by the Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial. 1 The approval was made under the Priority Review designated by the MHLW earlier this year. CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke. 2-4 The condition affects 840 million people worldwide and approximately 13 million people in Japan. 5,6 However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease. 4 Forxiga is the first ever approved medicine for the treatment of the disease in Japan. 7,8 The national coordinator of the DAPA-CKD Phase III trial in Japan, Naoki Kashihara, President of Japanese Society of Nephrology, said: “DAPA-CKD is the landmark trial that demonstrated unprecedented risk reduction for chronic kidney disease patients with and without type-2 diabetes. This transformational milestone will bring great hope to many patients with chronic kidney disease in Japan.” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “This approval is an important step towards realising our ambition of improving outcomes for patients with chronic kidney disease. While new medicines like Forxiga advance the standard of care, we are also committed to the prevention and early detection of this often debilitating and life-threatening disease.” The DAPA-CKD Phase III trial demonstrated that Forxiga, on top of standard-of-care (SoC) treatment with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39%, the primary composite endpoint, compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. Forxiga also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo. 9 The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine. Forxiga (known as Farxiga in the US) was recently approved in the US and the European Union for the treatment of CKD in adults with and without T2D and is currently under review in several other countries around the world. Forxiga is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). It is also approved for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults with and without T2D. In 2013, AstraZeneca K.K. (AZKK), a subsidiary in Japan of AstraZeneca, entered into an agreement with Ono Pharmaceutical Co., Ltd. (Ono) for Forxiga. Based on this agreement, Ono is responsible for distribution and marketing of Forxiga in Japan and has been co-promoting it with AZKK for the treatment of T2D, T1D and chronic HF. Both Companies will co-promote for the treatment of CKD. ＊＊＊＊＊ Chronic Kidney Disease (CKD) CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months). 4 The most common causes of CKD are diabetes, hypertension and glomerulonephritis. 10 CKD is associated with significant patient morbidity and an increased risk of CV events, such as HF and premature death. In its most severe form, known as ESKD, kidney damage and deterioration of kidney function have progressed to the point where dialysis or kidney transplantation are required. 2 The majority of patients with CKD will die from CV causes before reaching ESKD. 11 Currently in Japan, more than 13 million people are living with CKD. 6 DAPA-CKD DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase III trial in 4,304 patients designed to evaluate the efficacy of Forxiga 10mg, compared with placebo, in patients with CKD Stage 2-4 and elevated urinary albumin excretion, with and without T2D. Forxiga was given once daily in addition to SoC. The primary composite endpoint was worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, onset of ESKD or death from CV or renal cause). The secondary endpoints included the time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD or renal death), the composite of CV death or hospitalisation for HF (hHF), and death from any cause. The trial was conducted in 21 countries. 1 Detailed results from the trial were published in The New England Journal of Medicine . 1 Forxiga Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Forxiga’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas. 1,12,13 Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including T2D, HF and CKD. 14-16 Forxiga is approved as an adjunct to diet and exercise to improve glycaemic control in adults with T2D and in T2D to reduce the risk of hHF or CV death when added to SoC based on the findings of the DECLARE-TIMI 58 Phase III CV outcomes trial. 12 Forxiga is also approved for the treatment of HFrEF and the treatment of CKD based on the findings of the DAPA-HF and DAPA-CKD Phase III trials. 1,13 Indications of Forxiga approved in Japan: - Type 2 diabetes mellitus - Type 1 diabetes mellitus - Chronic heart failure (limited to the patients who receive standard of care for chronic heart failure) - Chronic kidney disease (excluding patients with end-stage renal disease or undergoing dialysis) DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of Forxiga. It includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience. Forxiga is currently being tested in the DELIVER Phase III trial to evaluate its efficacy in the treatment of patients with HF with preserved ejection fraction with or without T2D and in the DAPA-MI Phase III trial - a first of its kind, indication-seeking registry-based randomised controlled trial in patients without T2D following an acute myocardial infarction (MI) or heart attack. AstraZeneca in CVRM Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca’s main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca . In Japan, AstraZeneca is actively working to further contribute to the health and medical development of patients with primary focus on Oncology, Cardiovascular, Renal and Metabolism, and Respiratory, Immunology fields. For more information, please visit https://www.astrazeneca.co.jp/ Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on the oncology, immunology, neurology and specialty research with high medical needs, as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website https://www.ono-pharma.com/ . References Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446. Centers for Disease Control and Prevention (CDC) [Internet]. Chronic kidney disease in the United States; 2019 [cited 2021 Jul 08]. Available from: URL: https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html / Segall L, et al. Heart failure in patients with chronic kidney disease: a systematic integrative review. Biomed Res Int. 2014;2014:937398. Bikbov B, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733. Jager KJ, et al. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Nephrol Dial Transplant. 2019;34(11):1803-1805. Okada K, et al. Evidence-based clinical practice guidelines for chronic kidney disease 2018. Tokyo Medical Co., Ltd; 2018 Jun. Fukui, A., Yokoo, T., Nangaku, M. et al. New measures against chronic kidney diseases in Japan since 2018. Clinical and Experimental Nephrology. 2019;23:1263–1271. National Health Service [Internet]. Chronic kidney disease; Treatment; 2016 [cited 2021 Jul 09]. Available from: URL: https://www.nhs.uk/conditions/kidney-disease/treatment/ . Heerspink H. DAPA-CKD - Dapagliflozin in Patients with Chronic Kidney Disease. presented at: ESC Congress 2020 - The Digital Experience, 2020 August 29 - September 01. National Kidney Foundation [Internet]. Kidney Disease: Causes; 2015 [cited 2021 Jul 08]. Available from: URL: https://www.kidney.org/atoz/content/kidneydiscauses. Briasoulis A, Bakris GL. Chronic kidney disease as a coronary artery disease risk equivalent. Curr Cardiol Rep. 2013;15(3):340. Wiviott SD et al., for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type-2 diabetes [article and supplementary appendix]. N Engl J Med. 2019;380:347-357. McMurray J et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019; 381:1995-2008 Mayo Clinic [Internet]. Heart failure; 2020 [cited 2021 Jul 09]. Available from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142 Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States; 2020 [cited 2021 Jul 09]. Available from: URL: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html . National Institute of Diabetes and Digestive And Kidney Diseases (NIH) [Internet]. Heart disease & kidney disease; 2016 [cited 2021 Jul 09]. Available from: URL: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease . Back to List ono-pharma.com ↗
AstraZeneca K.K. (Osaka, Japan; President and Representative Director: Stefan Woxstrӧm) and Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director: Gyo Sagara) announced that Forxiga® (generic name: dapagliflozin propylene glycolate hydrate) Tablets 5mg, 10mg (“Forxiga”), an inhibitor of sodium-glucose co-transporter 2 (SGLT2), received an additional approval for the indication of “chronic kidney disease (excluding patients with end-stage renal disease or undergoing dialysis)” with and without type-2 diabetes on August 25, 2021. |
| 2021-08-26 | AstraZeneca | Regulatory Forxiga approved in Japan for the treatment of chronic kidney disease in patients with and without type-2 diabetes astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). |
| 2021-08-09 | AstraZeneca | Regulatory Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type-2 diabetes astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). |
| 2021-06-28 | AstraZeneca | Regulatory Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). |
| 2021-04-30 | AstraZeneca | Regulatory Farxiga approved in the US for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes astrazeneca.com ↗ |
| 2021-04-12 | AstraZeneca | Results Update on the DARE-19 Phase III trial for Farxiga in COVID-19 astrazeneca.com ↗
The trial did not achieve statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days. |
| 2021-02-04 | AstraZeneca | Regulatory Forxiga approved in China for heart failure astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF). |
| 2021-01-06 | AstraZeneca | Regulatory Farxiga granted Priority Review in the US for the treatment of patients with chronic kidney disease astrazeneca.com ↗
AstraZeneca’s Farxiga (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). |
| 2020-11-30 | AstraZeneca | Regulatory Forxiga approved in Japan for chronic heart failure astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving standard of care. |
| 2020-11-05 | AstraZeneca | Regulatory Forxiga approved in the EU for heart failure astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin) has been approved in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D). |
| 2020-10-29 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Dapagliflozin Tablets zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Dapagliflozin Tablets, 5 mg and 10 mg (US RLD: Farxiga® Tablets). |
| 2020-10-28 | AstraZeneca | Regulatory Forxiga cardiovascular outcomes benefit approved in China astrazeneca.com ↗
China’s National Medical Products Administration (NMPA) has updated the label for AstraZeneca’s Forxiga (dapagliflozin) to include data from the DECLARE-TIMI 58 Phase III trial. |
| 2020-10-23 | AstraZeneca | Results Farxiga DAPA-CKD Phase III trial reduced worsening of kidney function, risk of cardiovascular or renal death in patients with chronic kidney disease, irrespective of underlying cause astrazeneca.com ↗ |
| 2020-10-19 | AstraZeneca | Regulatory Forxiga recommended for approval in the EU by CHMP for heart failure astrazeneca.com ↗
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D). |
| 2020-10-02 | AstraZeneca | Regulatory Farxiga granted Breakthrough Therapy Designation in US for chronic kidney disease astrazeneca.com ↗
AstraZeneca’s Farxiga (dapagliflozin) has been granted Breakthrough Therapy Designation (BTD) in the US for patients with chronic kidney disease (CKD), with and without type-2 diabetes (T2D). |
| 2020-08-30 | AstraZeneca | Results Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease in the Phase III DAPA-CKD trial astrazeneca.com ↗
The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo. |
| 2020-07-28 | AstraZeneca | Results Farxiga met all primary and secondary endpoints in groundbreaking Phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease astrazeneca.com ↗ |
| 2020-07-16 | AstraZeneca | Regulatory Farxiga granted Fast Track Designation in the US for heart failure following acute myocardial infarction leveraging an innovative registry-based trial design astrazeneca.com ↗ |
| 2020-05-06 | AstraZeneca | Regulatory Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction astrazeneca.com ↗
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). |
| 2020-03-30 | AstraZeneca | Results Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease astrazeneca.com ↗
The decision to stop the trial early was made following a routine assessment of efficacy and safety which showed Farxiga’s benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial. |
| 2020-03-28 | AstraZeneca | Results Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial astrazeneca.com ↗ |
| 2020-01-06 | AstraZeneca | Regulatory Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction astrazeneca.com ↗
AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). |
| 2019-11-15 | AstraZeneca | Regulatory Qtrilmet approved in the EU for the treatment of type-2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D). |
| 2019-10-21 | AstraZeneca | Regulatory Farxiga approved in the US to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. |
| 2019-09-16 | AstraZeneca | Regulatory FDA grants Fast Track designation for Farxiga in heart failure astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) |
| 2019-09-01 | AstraZeneca | Results Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure astrazeneca.com ↗
AstraZeneca today announced detailed results from the landmark Phase III DAPA-HF trial that showed Farxiga (dapagliflozin) on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure. |
| 2019-08-29 | AstraZeneca | Results AstraZeneca to present data at ESC Congress 2019 that potentially redefine the treatment of heart failure astrazeneca.com ↗
Farxiga DAPA-HF trial demonstrates significant benefits in patients with heart failure with and without diabetes |
| 2019-08-27 | AstraZeneca | Regulatory FDA grants Fast Track designation for Farxiga in chronic kidney disease astrazeneca.com ↗
The designation was assigned to CKD patients with and without type-2 diabetes (T2D). |
| 2019-08-20 | AstraZeneca | Results Farxiga met primary endpoint in landmark Phase III DAPA-HF trial for the treatment of patients with heart failure astrazeneca.com ↗
AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo. |
| 2019-08-05 | AstraZeneca | Regulatory Forxiga label updated in the EU in type-2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). |
| 2019-07-15 | AstraZeneca | Regulatory Update on US regulatory decision for Farxiga in type-1 diabetes astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) |
| 2019-07-01 | AstraZeneca | Regulatory Forxiga receives positive EU CHMP opinion for DECLARE-TIMI 58 cardiovascular outcomes data astrazeneca.com ↗
AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial. |
| 2019-05-03 | AstraZeneca | Regulatory Qternmet XR approved in the US for the treatment of type-2 diabetes astrazeneca.com ↗
The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D). |
| 2019-03-27 | AstraZeneca | Regulatory Forxiga approved in Japan for type-1 diabetes astrazeneca.com ↗
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). |
| 2019-03-25 | AstraZeneca | Regulatory Forxiga approved in Europe for type-1 diabetes astrazeneca.com ↗
Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for adults with type-1 diabetes and the first AstraZeneca medicine ever approved for type-1 diabetes |
| 2019-03-18 | AstraZeneca | Results First sub-analyses from the DECLARE-TIMI 58 trial further support the cardiovascular effects of Farxiga in type-2 diabetes astrazeneca.com ↗
Farxiga reduced major adverse cardiovascular events by 16% in patients who had a prior heart attack |
| 2019-02-01 | AstraZeneca | Regulatory Forxiga receives positive EU CHMP opinion for the treatment of adults with type-1 diabetes astrazeneca.com ↗
Forxiga is the first oral medicine recommended for approval in Europe as an adjunct treatment to insulin for adults with type-1 diabetes |
| 2018-11-12 | AstraZeneca | Results Farxiga significantly reduced hospitalisation for heart failure or CV death in a broad patient population with type-2 diabetes in the landmark DECLARE-TIMI 58 trial astrazeneca.com ↗ |
| 2018-10-22 | AstraZeneca | Results AstraZeneca to present new data demonstrating breadth of research portfolio in renal disease at ASN Kidney Week 2018 astrazeneca.com ↗
Reduction in albuminuria with dapagliflozin cannot be predicted by baseline clinical characteristics or changes in most other risk markers |
| 2018-09-24 | AstraZeneca | Results Farxiga achieved a positive result in the Phase III DECLARE-TIMI 58 trial, a large cardiovascular outcomes trial in 17,000 patients with type-2 diabetes astrazeneca.com ↗
Farxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death, one of the two primary efficacy endpoints. |
| 2018-06-23 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from the Comparative Trials with Sitagliptin (CompoSIT) Clinical Trial Program with JANUVIA® (sitagliptin) merck.com ↗
In the CompoSIT-R study, among patients with mild renal impairment inadequately controlled on metformin, with or without a sulfonylurea, treatment with JANUVIA showed non-inferiority and superiority in reducing A1C levels compared with patients treated with dapagliflozin. |
| 2018-05-21 | AstraZeneca | Regulatory Regulatory submission in Japan for Forxiga in type-1 diabetes astrazeneca.com ↗
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Forxiga (dapagliflozin), a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). |
| 2018-03-12 | AstraZeneca | Results New data from landmark CVD-REAL study of patients with type-2 diabetes confirms CV benefits associated with SGLT-2 Inhibitors astrazeneca.com ↗
There was also a 40% lower risk of the composite endpoint of hHF or ACD (p<0.001). |
| 2018-03-05 | AstraZeneca | Regulatory The European Medicines Agency accepts regulatory submission for Forxiga in adults with type-1 diabetes astrazeneca.com ↗
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). |
| 2017-11-20 | Janssen Research & Development, LLC | Results New Real-World Analysis Shows INVOKANA® (canagliflozin) and Other SGLT2 Inhibitors Reduced the Risk of Death and Cardiovascular Events Compared to Other Diabetes Medicines jnj.com ↗
EASEL is the first real-world study to show adults with type 2 diabetes and established cardiovascular disease (CVD) have a lower risk of major adverse cardiovascular events (MACE) with SGLT2i therapy |
| 2017-06-12 | AstraZeneca | Results AstraZeneca presents new data underpinning safety profile and real-world CV outcomes of Farxiga at ADA 2017 astrazeneca.com ↗
In an updated safety analysis, data pooled from 30 Phase IIb/III clinical trials for dapagliflozin showed no new safety signals and the incidence of adverse events was generally similar to that in the control groups. |
| 2017-03-19 | AstraZeneca | Results AstraZeneca’s CVD-REAL study shows SGLT-2 inhibitors significantly reduced death and hospitalisations for heart failure versus other type-2 diabetes medicines astrazeneca.com ↗
Landmark real-world evidence from an international study of more than 300,000 patients with type-2 diabetes showed treatment with SGLT-2 inhibitors reduced all-cause mortality by 51% and risk of hospitalisation for heart failure by 39% |
| 2017-02-28 | AstraZeneca | Regulatory FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. |
| 2016-09-16 | AstraZeneca | Results Phase III combination trial of Bydureon and Forxiga shows significant benefits in patients with type-2 diabetes astrazeneca.com ↗
The trial achieved its primary endpoint with the combination of exenatide and dapagliflozin significantly reducing HbA1c from baseline compared with exenatide or dapagliflozin alone (1.95% versus 1.58% and 1.37% respectively, both P<0.01)1 at 28 weeks. |
| 2016-07-19 | AstraZeneca | Regulatory AstraZeneca receives approval in the EU for Qtern (saxagliptin and dapagliflozin) for treatment of Type 2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. |
| 2016-05-27 | AstraZeneca | Regulatory Positive CHMP opinion in EU for saxa/dapa (saxagliptin and dapagliflozin) for adults with type-2 diabetes astrazeneca.com ↗
27 May 2016 AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes. |
| 2015-10-16 | AstraZeneca | Regulatory AstraZeneca receives Complete Response Letter from US FDA for saxagliptin / dapagliflozin fixed-dose-combination astrazeneca.com ↗
The CRL states that more clinical data are required to support the application. |
| 2015-09-17 | AstraZeneca | Results AstraZeneca presents positive pooled analysis demonstrating the effect of dapagliflozin on albuminuria in hypertensive patients with type 2 diabetes astrazeneca.com ↗
Secondary analysis of this data also demonstrated that the effect of dapagliflozin treatment on albuminuria appears to be independent of changes in HbA1c, SBP and eGFR. |
| 2015-06-06 | AstraZeneca | Results AstraZeneca presents new positive phase III data on triple therapy approach with dapagliflozin, saxagliptin and metformin for the treatment of type 2 diabetes astrazeneca.com ↗
Data in oral presentation demonstrate that the investigational combination of dapagliflozin, saxagliptin and metformin resulted in statistically significant reductions in HbA1c in patients uncontrolled on saxagliptin and metformin |
| 2014-10-30 | AstraZeneca | Regulatory US FDA approves once-daily XIGDUO™ XR tablets for adults with Type 2 Diabetes astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. |
| 2014-05-15 | AstraZeneca | Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
Positive results from Phase III study of saxagliptin/dapagliflozin combination in patients with type 2 diabetes inadequately controlled on metformin and outlines future development plans for the oral antidiabetic franchise. |
| 2014-05-13 | AstraZeneca | Results AstraZeneca announces positive results from Phase III study of saxagliptin/dapagliflozin combination in patients with type 2 diabetes inadequately controlled on metformin and outlines future development plans for the oral antidiabetic franchise astrazeneca.com ↗
AstraZeneca today announced results from a Phase III study evaluating the investigational combination of saxagliptin/dapagliflozin as a dual add-on therapy in adult patients with type 2 diabetes who were inadequately controlled on metformin. |
| 2014-03-24 | AstraZeneca | Regulatory Forxiga® receives regulatory approval in Japan for the treatment of type 2 diabetes astrazeneca.com ↗
AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved FORXIGA® (dapagliflozin in 5 and 10 mg tablets), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, as a once-daily oral treatment for type 2 diabetes. |
| 2014-01-13 | AstraZeneca | Regulatory US FDA approves FARXIGA™ (dapagliflozin) tablets for the treatment of adult patients with type 2 diabetes astrazeneca.com ↗ |
| 2014-01-13 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Farxiga™ (Dapagliflozin) Tablets for the Treatment of Adult Patients with Type 2 Diabetes bms.com ↗ |
| 2014-01-08 | AstraZeneca | Regulatory AstraZeneca and Bristol-Myers Squibb announce US FDA approval of FARXIGA™ (dapagliflozin) astrazeneca.com ↗
Thursday, 8 January 2014 AstraZeneca and Bristol-Myers Squibb Company today announced the US Food and Drug Administration (FDA) approved FARXIGA™ (dapagliflozin). |
| 2014-01-08 | Bristol-Myers Squibb | Regulatory AstraZeneca and Bristol-Myers Squibb Announce U.S. FDA Approval of Farxiga™ (dapagliflozin) bms.com ↗
AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Farxiga ™ (dapagliflozin). |
| 2013-12-12 | AstraZeneca | Regulatory FDA Advisory Committee recommends the investigational SGLT2 inhibitor dapagliflozin for treatment of type 2 diabetes in adults astrazeneca.com ↗
Thursday, 12 December 2013 AstraZeneca and Bristol-Myers Squibb Company today announced the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. |
| 2013-12-12 | Bristol-Myers Squibb | Regulatory FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for the Treatment of Type 2 Diabetes in Adults bms.com ↗
AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. |
| 2013-11-22 | Bristol-Myers Squibb | Regulatory Xigduo™ (dapagliflozin and metformin hydrochloride) Receives Positive CHMP Opinion in the European Union for the Treatment of Type 2 Diabetes bms.com ↗
This is the first CHMP recommendation for a SGLT2 and metformin hydrochloride fixed dosage combination. |
| 2013-09-24 | AstraZeneca | Results New Phase III data showed dapagliflozin significantly reduced HBA1C compared to placebo at 24 weeks in patients with type 2 diabetes inadequately controlled with the combination of metformin plus sulfonylurea astrazeneca.com ↗
Dapagliflozin added to metformin plus sulfonylurea demonstrated significantly greater improvements in HbA1c from baseline compared to placebo |
| 2013-09-24 | Bristol-Myers Squibb | Results New Phase III Data Showed Dapagliflozin Significantly Reduced HbA1c Compared to Placebo at 24 Weeks in Patients with Type 2 Diabetes Inadequately Controlled with the Combination of Metformin Plus Sulfonylurea bms.com ↗
Patients treated with dapagliflozin 10 mg as an add-on therapy to metformin plus sulfonylurea demonstrated significant improvements in glycosylated hemoglobin levels (HbA1c) and, among key secondary endpoints, significant reductions in fasting plasma glucose (FPG) and in body weight compared to placebo at 24 weeks. |
| 2013-07-25 | AstraZeneca | Regulatory US FDA acknowledges receipt of resubmission of the New Drug Application for investigational compound dapagliflozin for the treatment of type 2 diabetes astrazeneca.com ↗
AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. |
| 2013-07-25 | AstraZeneca | Regulatory AstraZeneca and Bristol-Myers Squibb resubmit dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S astrazeneca.com ↗
Thursday, 25 July 2013 AstraZeneca and Bristol-Myers Squibb today announced they have resubmitted to the U.S. Food and Drug Administration (FDA), a New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes. |
| 2013-07-25 | Bristol-Myers Squibb | Regulatory U.S. FDA Acknowledges Receipt of Resubmission of the New Drug Application for Investigational Compound Dapagliflozin for the Treatment of Type 2 Diabetes bms.com ↗
AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. |
| 2013-07-25 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Reports Second Quarter 2013 Financial Results bms.com ↗
The company and its partner AstraZeneca resubmitted to the FDA the New Drug Application for Forxiga for the treatment of adults with type 2 diabetes. |
| 2013-06-22 | Bristol-Myers Squibb | Results Phase IIa Study Assessing Safety and Tolerability of Dapagliflozin after 14 Days as Add-on to Insulin in Adult Patients with Type 1 Diabetes Presented at the 2013 American Diabetes Association Scientific Sessions® bms.com ↗
Results from this study showed that in patients treated with dapagliflozin, no subjects discontinued due to lack of glycemic control, few genital and urinary tract infections were reported and hypoglycemia was observed in all treatment groups. |
| 2012-11-14 | AstraZeneca | Regulatory FORXIGA™ (dapagliflozin) now approved in European Union for treatment of type 2 diabetes astrazeneca.com ↗
Wednesday, 14 November 2012 AstraZeneca and Bristol-Myers Squibb Company today announced that the European Commission has approved FORXIGA™ (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). |
| 2012-11-14 | Bristol-Myers Squibb | Regulatory Forxiga™ (dapagliflozin), First-In-Class SGLT2 That Works Independently of Insulin, Now Approved in European Union for Treatment of Type 2 Diabetes bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the European Commission has approved Forxiga ™ (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). |
| 2012-06-09 | AstraZeneca | Results New data show investigational compound dapagliflozin demonstrated significant reductions in blood sugar levels when added to sitagliptin in adults with type 2 diabetes at 24 weeks, with results maintained over 48 weeks astrazeneca.com ↗
In this study, dapagliflozin, in addition to diet and exercise, resulted in reduced blood sugar levels when added to sitagliptin, a DPP4 inhibitor. |
| 2012-06-09 | Bristol-Myers Squibb | Results New Data Show Investigational Compound Dapagliflozin Demonstrated Significant Reductions in Blood Sugar Levels When Added to Sitagliptin in Adults with Type 2 Diabetes at 24 Weeks, with Results Maintained Over 48 Weeks bms.com ↗
In this study, dapagliflozin, in addition to diet and exercise, resulted in reduced blood sugar levels when added to sitagliptin, a DPP4 inhibitor. |
| 2012-04-20 | AstraZeneca | Regulatory FORXIGA (dapagliflozin) receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes astrazeneca.com ↗
This is the first in the new SGLT2 class to receive a positive CHMP opinion for the treatment of type 2 diabetes, a disease where high unmet medical need exists. |
| 2012-01-19 | AstraZeneca | Regulatory AstraZeneca and Bristol-Myers Squibb receive complete response letter from US Food and Drug Administration for dapagliflozin astrazeneca.com ↗
The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. |
| 2012-01-19 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and AstraZeneca Receive Complete Response Letter from U.S. Food and Drug Administration for Dapagliflozin bms.com ↗
The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. |
| 2011-12-08 | Bristol-Myers Squibb | Results New Data Show Investigational Compound Dapagliflozin When Added to Glimepiride Maintained Reductions in Blood Sugar Levels in Adults with Type 2 Diabetes Over 48 Weeks of Treatment bms.com ↗
In addition to maintaining reductions in blood sugar levels, the 48-week study reported that patients taking dapagliflozin added to glimepiride maintained reductions in fasting plasma glucose levels (FPG), post-prandial glucose (PPG) and total body weight. |
| 2011-11-16 | Bristol-Myers Squibb | Results Meta-Analysis of Clinical Data on Cardiovascular Safety Presented for Investigational Compound Dapagliflozin in Adult Patients with Type 2 Diabetes bms.com ↗
The relative risk between dapagliflozin and the control group, measured by hazard ratio, was 0.67 (98% CI: 0.38, 1.18). |
| 2011-10-26 | AstraZeneca | Regulatory US Food and Drug Administration extends action date for dapagliflozin by three months astrazeneca.com ↗
AstraZeneca and Bristol-Myers Squibb Company announced today that the US Food and Drug Administration (FDA) has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. |
| 2011-10-26 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Extends Action Date for Dapagliflozin by Three Months bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. |
| 2011-07-20 | AstraZeneca | Regulatory FDA Advisory Committee makes recommendation on investigational compound dapagliflozin astrazeneca.com ↗
Wednesday, 20 July 2011 AstraZeneca and Bristol-Myers Squibb Company today reported the outcome of the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin. |
| 2011-07-19 | Bristol-Myers Squibb | Regulatory FDA Advisory Committee Makes Recommendation on Investigational Compound Dapagliflozin bms.com ↗
On the question: “Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus?” the Advisory Committee voted 6 yes and 9 no. |
| 2011-06-27 | AstraZeneca | Results Bristol Myers Squibb and AstraZeneca announce investigational compound DAPAGLIFLOZIN sustained glycemic control and weight reduction in study of Type2 Diabetes patients inadequately controlled with metformin astrazeneca.com ↗
Bristol-Myers Squibb Company and AstraZeneca announced on June 25th results from an exploratory 78-week study extension of a Phase 3 clinical study that showed the investigational compound dapagliflozin plus metformin sustained greater mean reductions from baseline in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin over 102 weeks. |
| 2011-06-27 | Bristol-Myers Squibb | Results Investigational Compound Dapagliflozin with Metformin Extended-Release (XR) as Initial Combination Therapy Significantly Improved Blood Sugar Control in Previously-Untreated Adult Type 2 Diabetes Patients with High Blood Sugar Levels bms.com ↗
The studies showed that dapagliflozin in combination with metformin XR improved morning blood sugar (fasting plasma glucose, or FPG), had a higher proportion of patients achieving a therapeutic glycemic response of HbA1c < 7% and improved weight reduction compared to dapagliflozin or metformin XR alone. |
| 2011-06-26 | Bristol-Myers Squibb | Results Investigational Compound Dapagliflozin Added to Metformin Sustained Reductions in Blood Sugar Levels in Adult Patients with Type 2 Diabetes in Two-Year Study bms.com ↗
Episodes of low blood sugar were less frequent in patients treated with dapagliflozin added to metformin than in patients treated with glipizide added to metformin |
| 2011-06-25 | Bristol-Myers Squibb | Results Investigational Compound Dapagliflozin Sustained Glycemic Control and Weight Reduction in Study of Type 2 Diabetes Patients Inadequately Controlled with Metformin bms.com ↗
The reductions seen in the study ranged from -0.48 percent in patients receiving dapagliflozin 2.5mg plus metformin to -0.78 percent in patients receiving dapagliflozin 10 mg plus metformin, as compared to 0.02 percent in patients taking placebo plus metformin. |
| 2011-03-08 | AstraZeneca | Regulatory FDA accepts new drug application for investigational compound Dapagliflozin for the treatment of type 2 diabetes astrazeneca.com ↗
A Marketing Authorisation Application (MAA) for dapagliflozin has also been validated by the European Medicines Agency (EMA). |
| 2011-03-08 | Bristol-Myers Squibb | Regulatory FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the Treatment of Type 2 Diabetes bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus. |
| 2010-09-24 | AstraZeneca | Results 52-Week Phase 3 Study Found Investigational Drug Dapagliflozin Plus Metformin Similar to Glipizide Plus Metformin in Improving Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus astrazeneca.com ↗
The study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. |
| 2010-09-24 | Bristol-Myers Squibb | Results 52-Week Phase 3 Study Found Investigational Drug Dapagliflozin Plus Metformin Similar to Glipizide Plus Metformin in Improving Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus bms.com ↗
The study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. |
| 2010-09-20 | AstraZeneca | Results 24-Week Phase 3 Study Found Investigational Drug Dapagliflozin Improved Glycosylated Hemoglobin (HbA1c) When Added to Glimepiride in Adults with Type 2 Diabetes Mellitus astrazeneca.com ↗
More people taking dapagliflozin and glimepiride were able to achieve a target HbA1c of less than 7% compared to patients taking glimepiride alone. |
| 2010-09-20 | Bristol-Myers Squibb | Results 24-Week Phase 3 Study Found Investigational Drug Dapagliflozin Improved Glycosylated Hemoglobin (HbA1c) When Added to Glimepiride in Adults with Type 2 Diabetes Mellitus bms.com ↗
More people taking dapagliflozin and glimepiride were able to achieve a target HbA1c of less than 7% compared to patients taking glimepiride alone. |
| 2010-06-26 | Bristol-Myers Squibb | Results Dapagliflozin As Add On Therapy To Insulin Demonstrated Improved Glycemic Control in Patients With Type 2 Diabetes Inadequately Controlled With Insulin bms.com ↗
The study also demonstrated that dapagliflozin achieved reductions in the secondary endpoints that evaluated the change in total body weight from baseline, change from baseline in mean daily insulin dose, and change from baseline in fasting plasma glucose (FPG). |
| 2010-06-22 | Bristol-Myers Squibb | Results Dapagliflozin as Monotherapy Demonstrated Improved Glycemic Control in Treatment-Naïve Adults with Type 2 Diabetes bms.com ↗
Findings from a 24-week Phase 3 clinical study published online in the latest issue of Diabetes Care demonstrated that the investigational drug dapagliflozin, administered as a monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of glycosylated hemoglobin levels (HbA1c) in treatment-naïve adult patients with newly diagnosed type 2 diabetes, compared to placebo. |
| 2009-10-02 | Bristol-Myers Squibb | Results Dapagliflozin Study Demonstrated Significantly Improved Glycemic Control and Weight Reduction in Type 2 Diabetes Patients Inadequately Controlled with Metformin bms.com ↗
The study also showed that individuals receiving dapagliflozin had statistically greater mean reductions in body weight compared to individuals taking placebo. |
| 2009-06-06 | Bristol-Myers Squibb | Results Dapagliflozin Study Demonstrated Improved Glycemic Control In Type 2 Diabetes Patients Treated With High Doses of Insulin and Common Oral Anti-Diabetic Medicines bms.com ↗
The study also showed that individuals receiving dapagliflozin had greater reductions in body weight compared to individuals taking placebo, and support the findings from a previous 12-week, Phase 2b study. |
| 2009-03-27 | Bristol-Myers Squibb | Results Dapagliflozin Clinical Trial Results Indicate Improvement In Key Glycemic Measures In Treatment-Naïve Type 2 Diabetes Patients bms.com ↗
Findings published today in Diabetes Care from a 12-week, Phase IIb dose-ranging study showed that dapagliflozin, a novel, selective, sodium glucose co-transporter2 (SGLT2) inhibitor, produced clinically meaningful reductions across all key glycemic measures studied [glycosylated hemoglobin level (HbA1c), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG)] in treatment-naïve type 2 diabetes patients, compared to placebo. |
All press releases naming this drug 144 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 144 releases opens the full record — a long page | ||
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 625 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dapagliflozin | “HFrEF polypill strength 1: bisoprolol 2.5 mg + losartan 25 mg + eplerenone 25 mg + dapagliflozin 10 mg; HFrEF polypill strength 2: bisoprolol 5 mg + losartan 50 mg + eplerenone...” NCT06831864 ↗612“BACKGROUND AND OBJECTIVES: To establish pharmacokinetic bioequivalence and assess the safety of a single-dose administration of fixed-dose combination (FDC) tablet containing...” PMID 42270920 ↗ Jun 2026 “A total of 235 patients with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day) were randomized to receive either dapagliflozin/linagliptin fixed-dose...” PMID 39375869 ↗ Oct 2024 “Participants randomized to the intervention group will receive empagliflozin (10 mg once daily, with optional titration to 25 mg according to clinical judgement and...” NCT07694596 ↗ “Patients with acute decompensated HF will be open-label randomly assigned to be treated with or without SGLT2 inhibitors (either empagliflozin 10 mg once daily or dapagliflozin...” NCT06142474 ↗ “This clinical trial will evaluate whether combination therapy with Dapagliflozin + Macitentan improves outcomes compared to Dapagliflozin + placebo in patients with combined...” NCT07147114 ↗ “The primary objective of the study is to examine the effect of combination therapy with pioglitazone (15 mg) plus dapagliflozin (10 mg) versus placebo on hospitalization for...” NCT03794518 ↗ “The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and clinical guidelines applicable to patients with end-stage renal...” NCT06929169 ↗ “Sequential discontinuation of angiotensin receptor-neprilysin inhibitor (ARNI; e.g., sacubitril/valsartan) and sodium-glucose cotransporter-2 inhibitor (SGLT2i; e.g.,...” NCT07631156 ↗ “The study intervention is a HFrEF polypill consisting of bisoprolol (beta-blocker), losartan (ARB), eplerenone (MRA), and dapagliflozin (SGLT2i) manufactured using the...” NCT07569640 ↗ “Dulaglutide and Dapagliflozin Combination Concurrently Improves the Endothelial Glycocalyx and Vascular and Myocardial Function in Patients with T2DM and Albuminuria vs. DPP-4i.” PMID 39768420 ↗ Dec 2024 |
| Known as | A51R1 | “Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together” NCT04972539 ↗ |
| Known as | ATB-1012 | “ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10...” NCT07590466 ↗ |
| Known as | BMS -512148 | “The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated...” NCT01606007 ↗ |
| Known as | BMS-51248 | “The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control” NCT00643851 ↗ |
| Known as | CKD-380 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03601910 ↗ |
| Known as | DAPA | “Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor (SGLT2-I), has proven to be an effective hyperglycemic suppressor due to its role in inhibiting the...” NCT05792540 ↗28“The overarching hypothesis of this study is that vildagliptin (vilda) as add on therapy to metformin (met) in Egyptian type 2 diabetic obese patient will produce an equal, if...” NCT07077525 ↗ “FDA-approved drug dapagliflozin (Dapa) improves submaximal exercise endurance and skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) in patients with heart failure...” NCT04956809 ↗ “AIMS: To investigate the potential synergistic effects of combined exenatide (EXE) and dapagliflozin (DAPA) versus (PLAC) placebo and DAPA on hepatocellular lipid (HCL)...” PMID 33464703 ↗ Feb 2021 “treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and...” NCT04730947 ↗ “To investigate the effect of the SGLT2 inhibitor, dapagliflozin (DAPA), on cardiac function and the metabolic and hormonal response to moderate exercise in people with type 2 diabetes.” PMID 36274035 ↗ Mar 2023 “We evaluated the effects of dapagliflozin (DAPA) on measures of cardiovascular autonomic neuropathy (CAN), cardiac function, and glucose variability (GV) in T2D.” PMID 34024686 ↗ May 2021 “Dapagliflozin (DAPA) has shown renal and cardiometabolic benefits in nontransplanted patients with chronic kidney disease.” PMID 42102257 ↗ May 2026 “Dapagliflozin (DAPA) is an inhibitor of sodium-glucose cotransporter 2 prescribed for type 2 diabetes mellitus.” PMID 30689697 ↗ Apr 2019 “The efficacy of once-weekly exenatide (EQW) and dapagliflozin (DAPA) alone and coadministered” PMID 34097062 ↗ Sep 2021 “Dapagliflozin (DAPA), a sodium-glucose cotransporter 2 (SGLT2) inhibitor” NCT06427226 ↗ |
| Known as | dapagliflozin (Farxiga) | “dapagliflozin (Farxiga®)” NCT07325435 ↗ |
| Known as | Dapagliflozin 10mg (Farxiga) | “Dapagliflozin 10mg (Farxiga)” NCT05541484 ↗ |
| Known as | Dapagliflozin propanediol | “Dapagliflozin propanediol (FORXIGA) tablet: 10 mg once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.” NCT04869124 ↗1“Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)” NCT05764057 ↗ |
| Known as | Dapagliflozin/metformin IR FDC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01535677 ↗ |
| Known as | dapagliflozine | “Intervention: Dapagliflozine 10 mg once daily tablet treatment or Empagliflozin10 mg once daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment.” NCT04127084 ↗3“SGL2I(DAPAGLIFLOZINE at a dose (10 mg/day) orally” NCT06759077 ↗ “Drug: dapagliflozine” NCT07351864 ↗ |
| Known as | Dapagliglozin | “The 2019 DAPA-HF trial studied whether the addition of the SCLT-2 inhibitor dapagliglozin could benefit patients with heart failure with reduced ejection fraction (HFrEF),...” NCT04570865 ↗ |
| Known as | Diglifloz | “Dapagliflozin (Diglifloz) 10 mg orally once daily for 24 weeks and the standard therapy (ACEI or ARB).” NCT05966818 ↗ |
| Known as | Farxiga | “The investigational medicinal product (IMP) is Dapagliflozin 10 MG Oral Tablet [Farxiga] given once daily (film coated tablets, oral use).” NCT03887416 ↗19“Subjects receive once daily 10 mg of oral dapagliflozin (Farxiga) for 14 days (or until discharge).” NCT07273838 ↗ “The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.” NCT05194592 ↗ “Dapagliflozin 10 mg [Farxiga] for 3 months after catheter ablation of atrial fibrillation” NCT06111443 ↗ “Dapagliflozin therapy (Farxiga®, 10 mg tablets) is administered orally once daily” NCT06890143 ↗ “Sodium-glucose co-transporter 2 inhibitor (SGLT2i): Farxiga® (dapagliflozin) 5 mg” NCT04697485 ↗ “Drug: Dapagliflozin 10 milligrams [Farxiga]” NCT04591639 ↗ “Dapagliflozin 10 MG Oral Tablet [Farxiga]” NCT07025629 ↗ “Dapagliflozin 10 MG Oral Tablet [Farxiga]” NCT07589075 ↗ “Drug: Dapagliflozin 10 MG [Farxiga]” NCT05719714 ↗ “Drug: Dapagliflozin 10 MG [Farxiga]” NCT05250752 ↗ |
| Known as | FARXIGA1 | “Dapagliflozin propanediol (FORXIGA™/FARXIGA™1)” NCT05764057 ↗ |
| Known as | Forxiga | “each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of...” NCT05066516 ↗27“The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can...” NCT07682350 ↗ “ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10...” NCT07590466 ↗ “Dapagliflozin tablet 10 mg relative to Forxiga® film-coated tablets 10 mg, of AstraZeneca pharmaceuticals LP, Mount Vernon, Indiana, USA in healthy Thai volunteers under...” NCT06233045 ↗ “Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia” NCT06615674 ↗ “The goal of this single arm, prospective study is to test the therapeutic response of oral dapagliflozin (Forxiga) 10 mg/day for 24 weeks in non-diabetic MAFLD patients.” NCT05782972 ↗ “Patients with heart failure with preserved ejection fraction and type 2 diabetes mellitus treated with Dapagliflozin (Forxiga) 10 mg, one capsule per day orally.” NCT04739215 ↗ “FORXIGA（Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day.” NCT05848102 ↗ “The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.” NCT04004793 ↗ “patients receiving dapagliflozin (Forxiga; MP-002596) at a dose of 10 mg / day per os in addition to the current therapy” NCT04778787 ↗ “Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)” NCT06576375 ↗ |
| Known as | MP-002596 | “patients receiving dapagliflozin (Forxiga; MP-002596) at a dose of 10 mg / day per os in addition to the current therapy” NCT04778787 ↗ |
| Known as | THP-00101 | “THP-00101 (Dapagliflozin) 10mg” NCT06063109 ↗ |
| Action | Inhibit | “Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2” PMID 19114612 ↗ Dec 2008 |
| Modality | Small molecule | “SGLT2 inhibitor dapagliflozin” PMID 42467086 ↗ Jul 2026 |
| Route | Oral | “Tablets, Oral” NCT00263276 ↗ |
| Target | SLC5A2 | “a selective inhibitor of sodium-glucose cotransporter 2” PMID 30415602 ↗ Nov 2018 |