Drugs / Omarigliptin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | type 2 diabetes mellitus | 2014-11-24 | “submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals” merck.com ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01767688 | Jan → Mar 2013 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01407276 | Aug 2011 → Mar 2012 | chronic renal failure syndrome, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01088711 | Mar → May 2010 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01217073 | Oct 2010 → Jan 2012 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 311 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT01863667 | Jul 2013 → Apr 2014 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01841697 | Jun 2013 → Nov 2014 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01814748 | May 2013 → Sep 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT01755156 | Jan 2013 → Mar 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01717313 | Dec 2012 → Jun 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01697592 | Oct 2012 → May 2014 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01703221 | Oct 2012 → Apr 2014 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01704261 | Oct 2012 → Dec 2014 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01703208 | Oct 2012 → May 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01698775 | Oct 2012 → Jan 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01682759 | Sep 2012 → Jan 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 42 trials | ||||||
| Phase 4 | NCT06449235 | 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 | NCT02906709 | Oct 2016 → Aug 2018 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase not applicable1 trial | ||||||
| — | NCT04365907 | Mar → May 2020 | — | British University In Egypt | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT03362398 Comparator | Nov 2017 | type 2 diabetes mellitus | British University In Egypt | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2015-09-28 | Merck Sharp & Dohme LLC | Regulatory MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan merck.com ↗
Japan is the first country to have approved omarigliptin. |
| 2015-09-16 | Merck Sharp & Dohme LLC | Results Merck’s Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor, Achieved Similar A1C Reductions to JANUVIA® (sitagliptin) in Patients with Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy merck.com ↗
Omarigliptin was found to be non-inferior to Merck’s once-daily DPP-4 inhibitor, JANUVIA ® (sitagliptin), at reducing patients’ A1C * levels from baseline, with similar A1C reductions achieved in both groups. |
| 2014-11-24 | Merck Sharp & Dohme LLC | Regulatory Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes merck.com ↗
today announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). |
| 2014-09-17 | Merck Sharp & Dohme LLC | Results Merck Presents First Phase 3 Data in Japanese Patients for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes merck.com ↗
In a study in Japanese patients, omarigliptin provided comparable efficacy and tolerability to Merck’s once-daily DPP-4 inhibitor JANUVIA ® (sitagliptin) 50 mg, which is the standard starting dose for sitagliptin in Japan. |
| 2012-10-03 | Merck Sharp & Dohme LLC | Results Phase IIb Data Showed Merck’s Investigational Once-Weekly DPP-4 Inhibitor MK-3102 Significantly Lowered Blood Sugar in Patients with Type 2 Diabetes merck.com ↗
MK-3102 significantly lowered blood sugar in this 12-week study compared with placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo, in patients with type 2 diabetes. |
All press releases naming this drug 8 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omarigliptin | “one Marizev® tablet nominally containing 12.5 mg of Omarigliptin” NCT04365907 ↗ |
| Known as | Marizev | “one Marizev® tablet nominally containing 12.5 mg of Omarigliptin” NCT04365907 ↗ |
| Known as | MK-3102 | “A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on...” NCT01682759 ↗9“Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes.” PMID 26310692 ↗ Aug 2015 “Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus” NCT01704261 ↗ “Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly” NCT01703208 ↗ “Chemical name: MK-3102 Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor” NCT06449235 ↗ “Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly.” NCT01697592 ↗ “Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly” NCT01863667 ↗ “Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly” NCT01703221 ↗ “Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks” NCT01841697 ↗ |
| Known as | Omarigliptina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105762 ↗ |
| Known as | Omarigliptine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105762 ↗ |
| Known as | Zafatek tablets | “Other Name: Zafatek tablets” NCT04365907 ↗ |
| Action | Inhibit | “Omarigliptin (MK-3102) is a potent, oral, long-acting dipeptidyl peptidase (DPP)-4 inhibitor” PMID 26869191 ↗ Feb 2016 |
| Modality | Small molecule | — CHEMBL2105762 ↗ |
| Route | Oral | “Omarigliptin (MK-3102) is a potent, oral, long-acting dipeptidyl peptidase (DPP)-4 inhibitor” PMID 26869191 ↗ Feb 2016 |
| Target | DPP4 | “q.w. DPP-4 inhibitor omarigliptin” PMID 28589493 ↗ Jun 2017 |