Ertugliflozin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | STEGLATRO | — | 2021-09-17 | fda.gov ↗ |
| Approved | EU (EMA) | Steglatro | — | 2018-03-21 | europa.eu ↗ |
| Approved | US (FDA) | STEGLUJAN | — | 2017-12-19 | fda.gov ↗ |
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04167761 | Jul 2020 → Dec 2023 | atherosclerosis, type 2 diabetes mellitus | Stanford University | Completed | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT05662865 | Mar 2023 → Jul 2024 overdue | — | AdventHealth Translational Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02411929 | Oct 2014 → Jan 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02115347 | Sep 2014 → Jan 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01948986 | Oct 2013 → Oct 2014 | impaired renal function disease, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01223339 | Oct 2010 → Feb 2011 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01127308 | Jun → Jul 2010 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01114568 | May → Jun 2010 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01054300 | Feb → Apr 2010 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01018823 | Dec 2009 → Mar 2010 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00989079 | Oct → Dec 2009 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04438213 | Mar 2021 → Dec 2025 overdue | heart failure | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT03416270 | Jun 2018 → Apr 2021 | heart failure, type 2 diabetes mellitus | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01096667 | May 2010 → Feb 2011 | hypertensive disorder, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01059825 | Feb 2010 → Jan 2011 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT04490681 | Aug 2020 → Dec 2021 | intrinsic cardiomyopathy | Yonsei University | Unknown | No outcome recorded |
| Phase 3 | NCT04029480 | Oct 2019 → Apr 2025 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT03717194 | Jun 2019 → Dec 2022 | heart failure, type 2 diabetes mellitus | Soo Lim | Completed | No outcome recorded |
| Phase 3 | NCT02630706 | Dec 2015 → Dec 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02226003 | Sep 2014 → Feb 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02099110 | Apr 2014 → May 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02036515 | Mar 2014 → Jun 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01999218 | Dec 2013 → Apr 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02033889 | Dec 2013 → Aug 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01986855 | Dec 2013 → Sep 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01986881 | Nov 2013 → Dec 2019 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01958671 | Oct 2013 → Jul 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07621380 | Jul 2026 → Jan 2028 expected | type 2 diabetes mellitus | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05644717 | Mar 2023 → Nov 2025 overdue | fatty liver disease, fibrotic liver disease, glucose metabolism disease | Getz Pharma | Recruiting | No outcome recorded |
| Phase 4 | NCT04027530 | Dec 2020 → Jan 2023 | diabetic kidney disease, type 2 diabetes mellitus | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 4 | NCT04505774 | Sep 2020 → Aug 2023 | COVID-19 | Matthew Neal MD | Completed | No outcome recorded |
| Phase 4 | NCT04071626 | Mar 2020 → Jan 2023 | diastolic heart failure, type 2 diabetes mellitus | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03813316 | May → Sep 2019 | type 2 diabetes mellitus | LMC Diabetes & Endocrinology Ltd. | Withdrawn | No outcome recorded |
| Phase 4 | NCT03640221 | Sep 2018 → May 2020 | essential hypertension, type 2 diabetes mellitus | Cedars-Sinai Medical Center | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT04600921 Comparator | Jun 2021 → Jun 2023 | symptomatic heart failure | Medical University of Graz | Terminated | No outcome recorded |
| Phase 3 | NCT04231331 Comparator | Nov 2020 → Nov 2023 | left ventricular failure, mitral valve insufficiency | Asan Medical Center | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | 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 | NCT05727579 Comparator | Jul 2023 → Nov 2025 | diabetic kidney disease, hypertensive disorder, type 2 diabetes mellitus | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 4 | NCT05152940 Comparator | Feb → Oct 2023 | symptomatic heart failure | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-12-22 | Pfizer | FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes pfizer.com ↗ |
| 2017-06-10 | Pfizer | Merck and Pfizer Announce that Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies pfizer.com ↗ |
| 2017-03-06 | Pfizer | Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes pfizer.com ↗ |
| 2016-09-15 | Pfizer | Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Sitagliptin and Metformin in People with Type 2 Diabetes pfizer.com ↗ |
| 2016-06-11 | Pfizer | Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin, an Investigational SGLT-2 Inhibitor, Met Primary Endpoints, Showing Significant A1C Reductions in Patients with Type 2 Diabetes pfizer.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ertugliflozin | “Chemical Name: Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin) Class: SGLT2 Inhibitors” NCT06449235 ↗39“Adding ertugliflozin (SGLT2i) add-on using a fixed-dose combination with metformin(Segluromet® 2.5/1000 mg BID)” NCT03813316 ↗ “dapagliflozin","empagliflozin","canagliflozin","ertugliflozin” NCT04505774 ↗ “ertugliflozin” NCT05662865 ↗ |
| Known as | MK-8835 | “Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)” NCT01223339 ↗9“A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)” NCT00989079 ↗ “Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)” NCT01054300 ↗ “This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus” NCT02036515 ↗ “Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)” NCT01114568 ↗ “A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)” NCT01127308 ↗ “Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)” NCT01059825 ↗ “following oral administration of unlabeled ertugliflozin (MK-8835) and intravenous (IV) and oral administration” NCT02411929 ↗ “Ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.” NCT02115347 ↗ “Ertugliflozin (PF-04971729, MK-8835)” NCT01096667 ↗ |
| Known as | MK-8835/PF-04971729 | “Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic...” NCT02226003 ↗ |
| Known as | PF-04971729 | “Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)” NCT01223339 ↗8“This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus” NCT02036515 ↗ “A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)” NCT00989079 ↗ “Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)” NCT01054300 ↗ “Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)” NCT01114568 ↗ “A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)” NCT01127308 ↗ “Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)” NCT01059825 ↗ “Ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.” NCT02115347 ↗ “Ertugliflozin (PF-04971729, MK-8835)” NCT01096667 ↗ |
| Known as | steglatro | “Adding both a DPP-4i as Fixed dose combination (Janumet) plus SGLT2i ertugliflozin (steglatro) as add-on to metformin.” NCT03813316 ↗ |
| Action | Inhibit | “Ertugliflozin, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2),” PMID 32337660 ↗ Aug 2020 |
| Route | Oral | “After Administration of Single Escalating Oral Doses” NCT00989079 ↗ |