Ertugliflozin
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 2 diabetes mellitus 2 milestones | |||||
| Filed | EU (EMA) | — | type 2 diabetes mellitus | 2017-03-06 | “Additionally, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two...” pfizer.com ↗ “has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products.” merck.com ↗ |
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2017-03-06 | “the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin” pfizer.com ↗ “Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin” merck.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 · 2 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT01096667 | May 2010 → Feb 2011 | hypertensive disorder, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT01059825 | Feb 2010 → Jan 2011 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 312 trials · 8 met primary · 1 missed | ||||||
| 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 | Met primary |
| Phase 3 | NCT03717194 | Jun 2019 → Dec 2022 | heart failure, type 2 diabetes mellitus | Soo Lim | Completed | Met primary |
| Phase 3 | NCT02630706 | Dec 2015 → Dec 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02226003 | Sep 2014 → Feb 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02099110 | Apr 2014 → May 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02036515 | Mar 2014 → Jun 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01999218 | Dec 2013 → Apr 2017 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 47 trials · 1 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT04071626 | Mar 2020 → Jan 2023 | diastolic heart failure, type 2 diabetes mellitus | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03813316 | May → Sep 2019 | type 2 diabetes mellitus | LMC Diabetes & Endocrinology Ltd. | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03640221 | Sep 2018 → May 2020 | essential hypertension, type 2 diabetes mellitus | Cedars-Sinai Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy6 trials | ||||||
| Phase 3 | NCT04600921 Comparator | Jun 2021 → Jun 2023 | symptomatic heart failure | Medical University of Graz | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04231331 Comparator | Nov 2020 → Nov 2023 | left ventricular failure, mitral valve insufficiency | Asan Medical Center | Completed | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2020-06-16 | Merck Sharp & Dohme LLC | Results Merck and Pfizer’s SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) Meets Primary Endpoint in VERTIS CV Trial for Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease merck.com ↗
The study met the primary endpoint of non-inferiority on major adverse CV events (MACE), which is composed of a composite of CV death, nonfatal myocardial infarction or nonfatal stroke, compared to placebo. |
| 2017-12-22 | Pfizer | Regulatory FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes pfizer.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO™ (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets. |
| 2017-12-22 | Merck Sharp & Dohme LLC | Regulatory FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN™ (ertugliflozin and sitagliptin) for Adults with Type 2 Diabetes merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved STEGLATRO TM (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) tablets. |
| 2017-06-10 | Pfizer | Results Merck and Pfizer Announce that Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies pfizer.com ↗ |
| 2017-06-10 | Merck Sharp & Dohme LLC | Results Merck and Pfizer Announce That Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE:PFE), today announced that two Phase 3 studies (VERTIS MET and VERTIS SITA) of ertugliflozin, an investigational oral SGLT-2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes, met their primary endpoints. |
| 2017-03-06 | Pfizer | Regulatory 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 ↗
Additionally, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products. |
| 2017-03-06 | Merck Sharp & Dohme LLC | Regulatory 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 merck.com ↗
Additionally, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products. |
| 2016-09-15 | Pfizer | Results 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 ↗
Both 5 mg and 15 mg daily doses of ertugliflozin showed significantly greater reductions in A1C* of 0.69 percent and 0.76 percent, respectively, compared with placebo (p<0.001, for both comparisons), when added to patients on a background of sitagliptin (100 mg/day) and stable metformin (≥1500 mg/day). |
| 2016-09-15 | Merck Sharp & Dohme LLC | Results Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Sitagliptin and Metformin in People with Type 2 Diabetes merck.com ↗
These study results were presented for the first time during an oral session today at the 52 nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany. |
| 2016-06-11 | Pfizer | Results 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 ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Pfizer Inc. (NYSE:PFE), today announced that two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, met their primary endpoints. |
| 2016-06-11 | Merck Sharp & Dohme LLC | Results 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 merck.com ↗
The study results showed statistically significant reductions in A1C (a measure of average blood glucose) for both ertugliflozin doses tested (5 mg and 15 mg daily). |
All press releases naming this drug 15 releases
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“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 ↗ “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 ↗ |