SAXAGLIPTIN ANHYDROUS
Small molecule targets DPP4
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 2 diabetes mellitus 4 milestones | |||||
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2015-02-05 | “Saxagliptin/dapagliflozin FDC: filed in the US.” astrazeneca.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2009-12-29 | “Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.” bms.com ↗ |
| Filed | EU (EMA) | ONGLYZA | type 2 diabetes mellitus | 2008-07-01 | “a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA ™ (saxagliptin)” bms.com ↗ |
| Filed | US (FDA) | ONGLYZA | type 2 diabetes mellitus | 2008-06-30 | “In December, Bristol-Myers Squibb and AstraZeneca submitted an application with the U.S. Food and Drug Administration (FDA) for a fixed dose combination of ONGLYZA® (saxagliptin)” bms.com ↗ “The new drug application for ONGLYZA was submitted to the FDA on June 30, 2008” bms.com ↗ “The new drug application for ONGLYZA was submitted to the FDA on 30 June 2008” astrazeneca.com ↗ “The NDA for ONGLYZA was submitted to the FDA on June 30, 2008.” bms.com ↗ “The NDA for ONGLYZA was submitted to the FDA on 30 June 2008.” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | ONGLYZA | — | 2011-02-18 – 2024-10-11 | fda.gov ↗ |
| Approved | EU (EMA) | Onglyza | — | 2009-09-30 | europa.eu ↗ |
| Approved | US (FDA) | ONGLYZA | — | 2009-07-31 | fda.gov ↗ |
Trials 77 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 3 met primary | ||||||
| Phase 1 | NCT03169959 | May → Aug 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01525225 | Sep 2012 → Jun 2013 | type 2 diabetes mellitus | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT01662999 | Aug → Nov 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01582308 | Jun → Dec 2012 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT01441869 | Oct → Dec 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01305551 | Mar 2011 | type 2 diabetes mellitus | AstraZeneca | Withdrawn | No outcome recorded |
| Phase 1 | NCT00935467 | Jul → Aug 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00770302 | Oct 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT01521312 | Sep 2012 → Sep 2014 | glucose intolerance | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT00857558 | Jan 2009 → Mar 2010 | type 2 diabetes mellitus | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00950599 | May 2003 → May 2004 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 2/32 trials · 1 met primary | ||||||
| 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 | NCT02547935 | Sep 2015 → May 2018 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 332 trials · 23 met primary | ||||||
| Phase 3 | NCT03199053 | Oct 2017 → Feb 2023 | type 2 diabetes mellitus | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT02946632 | Dec 2016 → Dec 2019 | type 2 diabetes mellitus | Korea University Anam Hospital | Unknown | Met primary |
| Phase 3 | NCT02551874 | Oct 2015 → May 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02419612 | Aug 2015 → Aug 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02315495 | Apr 2015 → Aug 2016 | type 2 diabetes mellitus | Zilin Sun | Completed | No outcome recorded |
| Phase 3 | NCT02273050 | Dec 2014 → Aug 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02284893 | Sep 2014 → Sep 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02104804 | May 2014 → Feb 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02022007 | Mar 2014 → Aug 2016 | glucose metabolism disease, polycystic ovary syndrome | Woman's | Completed | Met primary |
| Phase 3 | NCT01606007 | Jul 2012 → Jan 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01619059 | Jun 2012 → Jun 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01434186 | May 2012 → Apr 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01204775 | Jun 2011 → Apr 2016 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01162876 | Jul → Nov 2010 | type 2 diabetes mellitus | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01128153 | Jun 2010 → Jun 2011 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00918138 | Aug 2009 → May 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00960076 | Aug 2009 → Oct 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00918879 | May 2009 → Jul 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00757588 | Nov 2008 → Apr 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00683657 | Jul 2008 → Feb 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00661362 | Jun 2008 → Sep 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00698932 | Jun 2008 → Oct 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00666458 | Apr 2008 → Mar 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00614939 | Jan 2008 → Jun 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00575588 | Dec 2007 → Aug 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00374907 | Sep 2006 → Jan 2008 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00316082 | Jun 2006 → Nov 2007 | diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00327015 | May 2006 → Nov 2007 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00313313 | Apr 2006 → Sep 2007 | diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00295633 | Mar 2006 → Oct 2007 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00121667 | Aug 2005 → Oct 2006 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00121641 | Jul 2005 → Aug 2006 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 428 trials · 2 met primary · 5 missed | ||||||
| Phase 4 | NCT04445714 | Apr 2021 → Mar 2023 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT03700801 | Oct 2018 → Dec 2019 | type 2 diabetes mellitus | Zhujiang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02765204 | Mar → Dec 2016 | type 2 diabetes mellitus | Uppsala University | Completed | No outcome recorded |
| Phase 4 | NCT02605772 | Dec 2015 → Nov 2016 | type 2 diabetes mellitus | Fifth Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 4 | NCT02742233 | Nov 2015 → Oct 2017 | ulcer of lower limbs | Long Min,MD | Unknown | No outcome recorded |
| Phase 4 | NCT02583438 | Oct 2015 → Oct 2017 | obesity disorder, type 2 diabetes mellitus | Beijing Chao Yang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02462369 | Jun 2015 → Apr 2017 | proteinuria | The Second Hospital of Nanjing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT02481479 | Jun 2015 → Aug 2018 | heart failure, type 2 diabetes mellitus | Unity Health Toronto | Completed | No outcome recorded |
| Phase 4 | NCT02407899 | Mar 2015 → Dec 2020 | type 1 diabetes mellitus | Second Xiangya Hospital of Central South University | Completed | Missed primary |
| Phase 4 | NCT02312427 | Jan 2015 → Mar 2016 | congestive heart failure, diabetes mellitus | Mitsui Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02920801 | Dec 2014 → Jul 2015 | type 2 diabetes mellitus | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02307695 | Nov 2014 → Mar 2017 | type 1 diabetes mellitus | Nanjing Medical University | Unknown | Missed primary |
| Phase 4 | NCT02243176 | Sep 2014 → Sep 2015 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT02182895 | Jul 2014 → Feb 2017 | type 2 diabetes mellitus | Brigham and Women's Hospital | Completed | Met primary |
| Phase 4 | NCT02089438 | May 2014 → Jun 2017 | type 2 diabetes mellitus | Lund University | Completed | No outcome recorded |
| Phase 4 | NCT02104739 | Apr 2014 → Mar 2017 | obesity disorder, prediabetes syndrome | The University of Texas Health Science Center, Houston | Completed | Missed primary |
| Phase 4 | NCT02386943 | Dec 2013 → Mar 2015 | type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01960205 | Aug 2013 → Dec 2014 | prediabetes syndrome | Shandong Provincial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02285985 | Feb 2013 → Oct 2019 | type 2 diabetes mellitus | Phoenix VA Health Care System | Completed | No outcome recorded |
| Phase 4 | NCT01608724 | Nov 2012 → May 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT01768208 | Oct 2012 → Dec 2016 | type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01660386 | Jul → Dec 2012 | type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01548651 | Feb 2012 → Aug 2017 | glucose intolerance | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01527747 | Jan 2012 → Nov 2024 | hypertriglyceridemia, type 2 diabetes mellitus | Oregon Health and Science University | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT01107886 | May 2010 → May 2013 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT01206647 | Feb 2010 → Feb 2011 | type 2 diabetes mellitus | ikfe-CRO GmbH | Unknown | No outcome recorded |
| Phase 4 | NCT01006590 | Oct 2009 → Dec 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 4 | NCT01006603 | Oct 2009 → Jun 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT04170790 | Dec 2019 | erectile dysfunction, type 2 diabetes mellitus | Ain Shams University | Unknown | No outcome recorded |
| — | NCT02148978 | Mar 2014 → Aug 2015 | cystic fibrosis | Ram Weiss | Unknown | No outcome recorded |
| — | NCT01974544 | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT01703637 | Oct 2012 → Dec 2016 | type 2 diabetes mellitus | Lin Liao | Unknown | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 0 | NCT03933787 Comparator | Jun → Jul 2018 | disorder of catecholamine synthesis, sympathetic nervous system disorder | Eric Grouzmann | Completed | No outcome recorded |
| Phase 2 | NCT03714594 Comparator | Jul 2018 → Aug 2022 | type 2 diabetes mellitus | University of Pisa | Completed | No outcome recorded |
| Phase 2 | NCT02597101 Background | Nov 2015 → Jun 2019 | type 2 diabetes mellitus | Nick Giannoukakis, PhD | Completed | Missed primary |
| Phase 2 | NCT01782261 Comparator | Feb 2012 → Feb 2015 | type 1 diabetes mellitus | Medical University of Graz | Completed | No outcome recorded |
| Phase 3 | NCT06107153 Comparator | Nov 2023 → Nov 2024 | type 2 diabetes mellitus | University of Basrah | Completed | No outcome recorded |
| Phase 3 | NCT03608358 Background | Feb 2019 → Aug 2020 | type 2 diabetes mellitus | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02377388 Comparator | Feb 2017 → Feb 2020 | platelet aggregation, spontaneous | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02681094 Comparator | Feb 2016 → Jul 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01922817 Comparator | Sep 2012 → Apr 2014 | hypoglycemia, type 1 diabetes mellitus | University of Dundee | Completed | No outcome recorded |
| Phase 3 | NCT01646320 Background | Sep 2012 → Aug 2014 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01242228 Background | Oct 2010 → Jun 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT01319357 Comparator | Oct 2010 → Apr 2013 | type 2 diabetes mellitus | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 3 | NCT00885378 Comparator | May 2009 → Feb 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04521049 Comparator | Mar 2019 → Mar 2020 | type 2 diabetes mellitus | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT03660683 Comparator | Oct 2018 → Mar 2021 | cardiovascular disorder, type 2 diabetes mellitus | Sabyasachi Sen | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02965443 Comparator | Feb 2018 → Feb 2020 | type 2 diabetes mellitus | University Hospital Tuebingen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03014479 Comparator | Feb → Oct 2017 | type 2 diabetes mellitus | Takeda | Completed | Missed primary |
| Phase 4 | NCT02917031 Comparator | Jan 2017 → Aug 2019 | heart failure, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02471404 Comparator | Sep 2015 → Mar 2017 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02528019 Comparator | Aug 2015 → Aug 2017 | — | Kurume University | Unknown | No outcome recorded |
| Phase 4 | NCT02304081 Comparator | Jan 2015 → Aug 2016 | type 2 diabetes mellitus | Prof. Dr. Thomas Forst | Completed | No outcome recorded |
| Phase 4 | NCT02280486 Comparator | Jan 2015 → Oct 2016 | type 2 diabetes mellitus | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Completed | No outcome recorded |
| Phase 4 | NCT01267448 Comparator | Sep 2014 → Jul 2015 | hyperglycemia, type 2 diabetes mellitus | Cook County Health | Completed | No outcome recorded |
| Phase 4 | NCT02024477 Comparator | Nov 2013 → Sep 2017 | type 2 diabetes mellitus | George Washington University | Completed | No outcome recorded |
| Phase 4 | NCT02365233 Comparator | May 2013 → Dec 2016 | NAFLD1, type 2 diabetes mellitus | The University of Texas Medical Branch, Galveston | Terminated | No outcome recorded |
| Phase 4 | NCT01765270 Comparator | Mar 2013 → Jun 2014 | cardiovascular disorder, type 2 diabetes mellitus | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01552018 Comparator | Mar 2012 → Feb 2014 | coronary artery disorder, type 2 diabetes mellitus | Oslo University Hospital | Completed | No outcome recorded |
| — | NCT02613897 Comparator | Jan 2016 → Jun 2018 | type 2 diabetes mellitus | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| — | NCT02239458 Comparator | Jun 2015 → Jun 2016 | cystic fibrosis | Ram Weiss | Unknown | No outcome recorded |
| — | NCT02244164 Comparator | Oct 2014 → Feb 2023 | type 2 diabetes mellitus | Erasme University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02969798 Comparator | Jan 2014 → Feb 2027 expected | glucose intolerance, prediabetes syndrome, type 2 diabetes mellitus | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 57
| Date | Issuer | Release |
|---|---|---|
| 2023-08-01 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg |
| 2023-02-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg |
| 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). |
| 2019-05-03 | 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). |
| 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. |
| 2016-07-19 | 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. |
| 2015-06-08 | AstraZeneca | Results New real-world data analysis finds no evidence of increased risk of hospitalisation for heart failure with saxagliptin compared with sitagliptin astrazeneca.com ↗
AstraZeneca today announced results from an observational, retrospective study which found no evidence of increased risk of hospitalisation for heart failure (hHF) with saxagliptin, compared with sitagliptin, both of which are dipeptidyl peptidase-4 (DPP-4) inhibitors, in patients with type 2 diabetes. |
| 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 |
| 2015-04-14 | AstraZeneca | Regulatory FDA Advisory Committee reviews SAVOR outcomes study results for ONGLYZA® (saxagliptin) and KOMBIGLYZE® XR (saxagliptin and metformin HCI extended-release) astrazeneca.com ↗
In addition, 14 out of 15 Committee members recommended that the FDA supplement the products’ labeling to add new safety information, with one vote to withdraw saxagliptin from the market. |
| 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. |
| 2013-09-26 | Kyowa Kirin, Inc. | Results Subanalyses of the SAVOR clinical trial for Onglyza® will be presented at the 49th Annual Meeting of the European Association for the Study of Diabetes kyowakirin.com ↗
Rates of pancreatitis were balanced between the Onglyza and placebo groups and majority of cases resolved without study treatment being withdrawn |
| 2013-09-26 | AstraZeneca | Results New hypoglycemia and pancreatitis subanalyses from the Onglyza® (saxagliptin) SAVOR cardiovascular outcomes trial presented at the 49th annual meeting of the European Association for the Study of Diabetes (EASD) astrazeneca.com ↗
Additionally, a greater percentage of patients taking Onglyza reached their target HbA1c without hypoglycemia, except patients who were treated with sulfonylreas alone at baseline. |
| 2013-09-26 | Bristol-Myers Squibb | Results New Hypoglycemia and Pancreatitis Subanalyses from the Onglyza® (saxagliptin) SAVOR Cardiovascular Outcomes Trial Presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD) bms.com ↗
Additionally, a greater percentage of patients taking Onglyza reached their target HbA1c without hypoglycemia, except patients who were treated with sulfonylureas alone at baseline. |
| 2013-09-02 | Kyowa Kirin, Inc. | Results Results of the SAVOR-TIMI53 clinical trial for Onglyza® will be presented at the European Society of Cardiology Congress and published in The New England Journal of Medicine kyowakirin.com ↗
(WILMINGTON, Del., and PRINCETON, N.J., September 2, 2013) - AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced the full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. |
| 2013-09-02 | AstraZeneca | Results ONGLYZA® (saxagliptin) achieves primary safety endpoint, demonstrating no increased risk for cardiovascular death, heart attack or stroke in SAVOR cardiovascular outcomes trial astrazeneca.com ↗ |
| 2013-09-02 | Bristol-Myers Squibb | Results Onglyza® (saxagliptin) Achieves Primary Safety Endpoint, Demonstrating No Increased Risk for Cardiovascular Death, Heart Attack or Stroke in SAVOR Cardiovascular Outcomes Trial bms.com ↗
In this study, Onglyza ® (saxagliptin) met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo. |
| 2013-06-19 | AstraZeneca | Results AstraZeneca and Bristol-Myers Squibb announce top-line results for SAVOR-TIMI-53 cardiovascular outcomes trial of ONGLYZA® (SAXAGLIPTIN) astrazeneca.com ↗
Wednesday, 19 June 2013 AstraZeneca and Bristol-Myers Squibb announced today top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin). |
| 2013-06-19 | Bristol-Myers Squibb | Results AstraZeneca and Bristol-Myers Squibb Announce Top Line Results for SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza® (saxagliptin) bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin). |
| 2013-05-24 | Kyowa Kirin, Inc. | Regulatory Completion of Drug Price Listing and Marketing Authorization Transfer of Onglyza® Tablets 2.5mg, 5mg for Type 2 Diabetes kyowakirin.com ↗
Kyowa Hakko Kirin is preparing to launch Onglyza® now that the drug has been listed on the NHI drug price list. |
| 2013-03-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Obtains Marketing Approval in Japan for Onglyza Tablets to Treat Type 2 Diabetes; Transferred Rights to Kyowa Hakko Kirin® otsuka.co.jp ↗
Otsuka has obtained marketing approval for Onglyza Tablets 2.5mg and 5mg(generic name: saxagliptin hydrate) to treat type 2 diabetes. |
| 2013-03-25 | Kyowa Kirin, Inc. | Regulatory Otsuka Obtains Marketing Approval in Japan for Onglyza® Tablets to Treat Type 2 Diabetes; Transferred Rights to Kyowa Hakko Kirin kyowakirin.com ↗
Tokyo, Japan, March 25, 2013-Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Kyowa Hakko Kirin Co., Ltd.(Kyowa Hakko Kirin) today announced that Otsuka has obtained marketing approval for Onglyza® Tablets 2.5mg and 5mg(generic name: saxagliptin hydrate) to treat type 2 diabetes. |
| 2012-07-30 | Bristol-Myers Squibb | Results Pooled Analysis Showed Onglyza® (saxagliptin) Provided Improvements in Key Measures of Blood Sugar Control in Adults with Type 2 Diabetes at High Risk for CV Disease bms.com ↗ |
| 2011-11-29 | AstraZeneca | Regulatory KOMBOGLYZE™ receives marketing authorisation in the European Union for adult patients with Type 2 diabetes astrazeneca.com ↗
Tuesday, 29 November 2011 AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for KOMBOGLYZE™ (saxagliptin and metformin HCl immediate-release fixed dose combination) that will cover the 27 Member States of the European Union. |
| 2011-11-28 | Bristol-Myers Squibb | Regulatory ONGLYZA® (saxagliptin) Approved for Use in Europe as Combination Therapy With Insulin (With or Without Metformin) in Adults With Type 2 Diabetes bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the European Commission has approved ONGLYZA ® (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with type 2 diabetes. |
| 2011-09-23 | AstraZeneca | Regulatory KOMBOGLYZE™ (saxagliptin and metformin HCl immediate-release) receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes astrazeneca.com ↗ |
| 2011-09-16 | Bristol-Myers Squibb | Results ONGLYZA™ (saxagliptin) When Added to Insulin in Adults with Type 2 Diabetes Maintained Reductions in Blood Sugar Levels (HbA1c) Over 52 Weeks in Investigational Study Extension bms.com ↗
In the 52-week analysis, change from baseline in HbA1c in patients taking ONGLYZA 5 mg added to insulin (with or without metformin) was -0.75% compared to -0.38% for those taking placebo added to insulin (with or without metformin). |
| 2011-06-25 | Bristol-Myers Squibb | Results Investigational Study Reported ONGLYZA™ (saxagliptin) Added to Insulin Significantly Improved Blood Sugar Levels in Adults with Type 2 Diabetes Compared to Placebo Added to Insulin bms.com ↗
The results, which were presented at the 71 st American Diabetes Association (ADA) Scientific Sessions in San Diego, CA, showed that the study met its primary endpoint of mean change in HbA1c from baseline to week 24. |
| 2011-03-04 | AstraZeneca | Regulatory Onglyza becomes the first DPP4 inhibitor available for use in Europe in Type 2 Diabetes patients with moderate or severe renal impairment astrazeneca.com ↗
AstraZeneca and Bristol-Myers Squibb Company today announced that the European Commission has approved a label update for ONGLYZA® (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. |
| 2011-02-23 | AstraZeneca | Regulatory ONGLYZA™ US label update provides further evidence regarding use in renally impaired adults with type 2 diabetes astrazeneca.com ↗
AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) has approved the inclusion of data from two clinical studies in an update to the ONGLYZA (saxagliptin) US Prescribing Information for adult type 2 diabetes patients. |
| 2011-02-23 | Bristol-Myers Squibb | Regulatory ONGLYZA™ (saxagliptin) U.S. Label Update Provides Further Evidence Regarding Use in Renally Impaired Adults with 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 has approved the inclusion of data from two clinical studies in an update to the ONGLYZA ™ (saxagliptin) U.S. Prescribing Information for adult type 2 diabetes patients. |
| 2010-11-05 | AstraZeneca | Regulatory KOMBIGLYZE™ XR tablets approved in the US for the treatment of type 2 diabetes mellitus in adults astrazeneca.com ↗
Friday, 5 November 2010 AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) approved KOMBIGLYZE™ XR for the treatment of type 2 diabetes in adults. |
| 2010-11-05 | Bristol-Myers Squibb | Regulatory KOMBIGLYZE™ XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) approved KOMBIGLYZE ™ XR for the treatment of type 2 diabetes in adults. |
| 2010-06-26 | Bristol-Myers Squibb | Results ONGLYZA™ (saxagliptin) With Metformin as Initial Combination Therapy Provided 76-Week Long-Term Glycemic Control in Treatment-Naïve Adults With Type 2 Diabetes bms.com ↗
These data show that at 76 weeks, ONGLYZA and metformin when given as an initial treatment provided improved HbA1c levels for adult patients with type 2 diabetes. |
| 2010-06-26 | Bristol-Myers Squibb | Results 52-Week Study Finds ONGLYZA™ (saxagliptin) When Added to Metformin Was Non-Inferior to Titrated Glipizide When Added to Metformin in Reducing Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus bms.com ↗
This study found that the addition of ONGLYZA ™ (saxagliptin) 5 mg to existing metformin therapy achieved the primary objective of demonstrating non-inferiority compared to the addition of titrated glipizide (sulphonylurea) to existing metformin therapy in reducing glycosylated hemoglobin levels (HbA1c). |
| 2010-03-17 | Bristol-Myers Squibb | Regulatory U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza™ (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults bms.com ↗ |
| 2009-10-05 | AstraZeneca | Results Study Finds That ONGLYZA (saxagliptin) When Added to Metformin was Non-Inferior to Januvia (sitagliptin) When Added to Metformin in Reducing Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus astrazeneca.com ↗
In this study, overall adverse events were reported at a similar rate for individuals taking ONGLYZA 5 mg plus metformin and JANUVIA 100 mg plus metformin. |
| 2009-10-05 | AstraZeneca | Regulatory ONGLYZA (saxagliptin) Receives Marketing Authorisation in Europe for the Treatment of Type 2 Diabetes astrazeneca.com ↗
AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for ONGLYZA (saxagliptin) in the 27 countries of the European Union. |
| 2009-10-05 | Bristol-Myers Squibb | Results Study Finds That ONGLYZA™ (saxagliptin) When Added To Metformin Was Non-Inferior To JANUVIA (SITAGLIPTIN) When Added To Metformin In Reducing Hemoglobin (HbA1c) In Adults With Type 2 Diabetes Mellitus bms.com ↗
the addition of treatment with ONGLYZA ™ (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA ® (sitagliptin) 100 mg per day in reducing HbA1c from baseline. |
| 2009-10-05 | Bristol-Myers Squibb | Regulatory ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE/LSE: AZN) announced today that the European Commission has granted marketing authorisation for ONGLYZA TM in the 27 countries of the European Union. |
| 2009-08-01 | AstraZeneca | Regulatory FDA Approves ONGLYZA For The Treatment Of Type 2 Diabetes In The US astrazeneca.com ↗
AstraZeneca and Bristol-Myers Squibb today announced that the US Food and Drug Administration (FDA) has approved ONGLYZA (saxagliptin) for the treatment of type 2 diabetes mellitus in adults. |
| 2009-07-31 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves ONGLYZA™ (saxagliptin) for the Treatment of Type 2 Diabetes Mellitus in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) approved ONGLYZA ™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor. |
| 2009-07-31 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves ONGLYZA™ (saxagliptin) for the Treatment of Type 2 Diabetes Mellitus in Adults bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) approved ONGLYZA ™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor. |
| 2009-06-25 | AstraZeneca | Regulatory ONGLYZA (saxagliptin) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes astrazeneca.com ↗
The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development programme that included six core Phase III trials assessing the safety and efficacy of saxagliptin as a once daily therapy. |
| 2009-06-25 | Bristol-Myers Squibb | Regulatory ONGLYZA™ (Saxagliptin) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that their marketing authorization application for ONGLYZA™ (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea. |
| 2009-06-06 | Bristol-Myers Squibb | Results Interim Analysis of Long-Term Data with ONGLYZA™ (saxagliptin) When Added to Metformin in People with Inadequately Controlled Type 2 Diabetes Presented at ADA Annual Scientific Sessions bms.com ↗
Results were presented at the 69 th American Diabetes Association Annual Scientific Sessions. |
| 2009-04-23 | AstraZeneca | Regulatory US Food and Drug Administration Extends Review Timeline for Onglyza (Saxagliptin) New Drug Application astrazeneca.com ↗
Accordingly, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from 30 April 2009 to 30 July 2009. |
| 2009-04-23 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Extends Review Timeline for ONGLYZA™ (saxagliptin) New Drug Application bms.com ↗
Accordingly, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from April 30, 2009 to July 30, 2009. |
| 2009-04-02 | AstraZeneca | Regulatory ONGLYZA (Saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee astrazeneca.com ↗
The Advisory Committee unanimously recommended that the sponsors perform a post-marketing trial to confirm the cardiovascular profile of ONGLYZA. |
| 2009-04-01 | Bristol-Myers Squibb | Regulatory ONGLYZA™ (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee bms.com ↗
The Committee unanimously recommended that the Sponsors perform a post-marketing trial to confirm the cardiovascular profile of ONGLYZA. |
| 2008-09-09 | Bristol-Myers Squibb | Results ONGLYZATM (saxagliptin) With Metformin as Initial Combination Therapy Significantly Lowered A1C and Demonstrated Significant Improvements Across Key Measures of Glucose Control in Treatment Naïve People With Type 2 Diabetes bms.com ↗
The initial combination of saxagliptin and metformin was well tolerated over the course of the study, and significantly more people were able to achieve target A1C of less than 7 percent, compared to monotherapy with saxagliptin or metformin. |
| 2008-09-09 | Bristol-Myers Squibb | Results ONGLYZA(TM) (saxagliptin) With Metformin as Initial Combination Therapy Significantly Lowered A1C and Demonstrated Significant Improvements Across Key Measures of Glucose Control in Treatment Naive People With Type 2 Diabetes bms.com ↗
The initial combination of saxagliptin and metformin was well tolerated over the course of the study, and significantly more people were able to achieve target A1C of less than 7 percent, compared to monotherapy with saxagliptin or metformin. |
| 2008-09-08 | Bristol-Myers Squibb | Results ONGLYZA(TM) (saxagliptin) Demonstrated Significant Improvements Across Key Measures of Glucose Control When Added to a Sulfonylurea or Thiazolidinedione in People With Inadequately Controlled Type 2 Diabetes bms.com ↗
The addition of saxagliptin to SU or TZD was well tolerated over the course of the studies, and significantly more people were able to achieve target A1C of less than 7 percent versus the comparators. |
| 2008-07-23 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for ONGLYZA(TM) (saxagliptin) for the Treatment of Type 2 Diabetes bms.com ↗ |
| 2008-06-07 | Bristol-Myers Squibb | Results ONGLYZA(TM) (saxagliptin) Demonstrated Significant Reductions in Key Measures of Glucose Control in Treatment Naive People with Type 2 Diabetes bms.com ↗
Over 24 weeks, saxagliptin had an adverse event profile that appeared similar to placebo. |
All press releases naming this drug 60 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 112 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAXAGLIPTIN ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | - saxagliptine (Onglyza) | “- saxagliptine (Onglyza®)” NCT02244164 ↗ |
| Known as | BMS-477118 | “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 ↗2“hydroxyadamantyl compound BMS-477118 (saxagliptin), a highly efficacious, stable, and long-acting DPP-IV inhibitor” PMID 16033281 ↗ Jul 2005 “Saxagliptin (BMS-477118)” NCT01434186 ↗ |
| Known as | BMS-477118-11 | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | NSC-760407 | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Onglyza | “Patients would be assigned to saxagliptin (Onglyza® AstraZeneca Pharmaceuticals LP, Indiana, USA), either received a dose of 5 mg or 2.5 mg daily if patients had eGFR \<50...” NCT04521049 ↗4“Onglyza® (saxagliptin) 5 mg” NCT07033585 ↗ “Onglyza (saxagliptin)” NCT01441869 ↗ “Saxagliptin, Onglyza” NCT02551874 ↗ “Onglyza” NCT02243176 ↗ |
| Known as | SAXA | “dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA)” PMID 28228317 ↗ Oct 2016 |
| Known as | saxagliptin | “DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427 ↗107“The recommended dose of the dipeptidyl peptidase-4 inhibitor saxagliptin is 2.5 mg in patients with moderate or severe renal impairment” PMID 27402391 ↗ Jul 2016 “Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors” NCT06449235 ↗ “Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin” NCT03014479 ↗ “A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus” NCT01162876 ↗ “Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg” NCT02946632 ↗ “Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day” NCT02365233 ↗ “Metformin, Dapagliflozin and Saxagliptin” NCT03700801 ↗ “saxagliptin (2.5-5mg daily)” NCT02528019 ↗ “Drug: Saxagliptin” NCT03199053 ↗ |
| Known as | Saxagliptin component of qternmet | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | SAXAGLIPTIN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin hydrochloride component of kombiglyze | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin hydrochloride component of qtern | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin hydrochloride component of qternmet xr | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | Saxagliptin/Metformin XR FDC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01305551 ↗ |
| Known as | Saxagliptina | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Known as | saxagliptine | “- saxagliptine (Onglyza®)” NCT02244164 ↗ |
| Known as | SBMS-477118 | ChEMBL registry synonym — accepted as the source's own label CHEMBL385517 ↗ |
| Action | Inhibit | “dipeptidyl peptidase-4 inhibitor saxagliptin” PMID 27402391 ↗ Jul 2016 |
| Modality | Small molecule | — CHEMBL385517 ↗ |
| Route | Oral | “Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)” NCT00121667 ↗ |
| Target | DPP4 | “dipeptidyl peptidase-4 inhibitor” PMID 27402391 ↗ Jul 2016 |