Drugs / Imeglimin
Imeglimin
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03802786 | Nov 2018 → Jul 2019 | — | Poxel SA | Completed | No outcome recorded |
| Phase 1 | NCT03618316 | Jun → Jul 2018 | — | Poxel SA | Completed | No outcome recorded |
| Phase 1 | NCT02924337 | Sep → Dec 2016 | PR interval, variation in | Poxel SA | Completed | No outcome recorded |
| Phase 1 | NCT02373150 | Feb → Oct 2015 | type 2 diabetes mellitus | Poxel SA | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01951235 | Jan 2013 → Jul 2014 | type 2 diabetes mellitus | Poxel SA | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07436182 | Mar → Jun 2026 overdue | — | Mansoura University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05366868 | May 2022 → Aug 2026 overdue | type 2 diabetes mellitus | National Center for Global Health and Medicine, Japan | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-08-07 | Sumitomo Pharma America, Inc. | Results Sumitomo Pharma Announces Topline Results from Post-Marketing Clinical Study on TWYMEEG for the Treatment of Type 2 Diabetes in Japan sumitomo-pharma.com ↗
The incidence of adverse events in the Study was 68.3% (41 of 60 subjects) and most of the adverse events were mild or moderate in severity. |
| 2024-08-07 | Sumitomo Pharma America, Inc. | Results 【Joint press release】Sumitomo Pharma and Poxel Announce Topline Results from Post-Marketing Clinical Study on TWYMEEG for the Treatment of Type 2 Diabetes in Japan sumitomo-pharma.com ↗
Safety and tolerability profile observed, consistent with prior clinical studies in the general type 2 diabetes population |
| 2021-06-23 | Sumitomo Pharma America, Inc. | Regulatory Poxel and Sumitomo Dainippon Pharma Announce the Approval of TWYMEEG (Imeglimin hydrochloride) for the Treatment of Type 2 Diabetes in Japan sumitomo-pharma.com ↗ |
| 2020-07-30 | Sumitomo Pharma America, Inc. | Regulatory Sumitomo Dainippon Pharma Submits New Drug Application for Approval of Manufacturing and Marketing for Imeglimin Hydrochloride for the Treatment of Type 2 Diabetes in Japan sumitomo-pharma.com ↗
it submitted today a new drug application for approval of manufacturing and marketing for imeglimin hydrochloride (generic name) in Japan for the treatment of type 2 diabetes. |
| 2019-12-20 | Sumitomo Pharma America, Inc. | Results Poxel and Sumitomo Dainippon Pharma Announce Positive Topline Phase 3 Results from TIMES 2 Trial of Imeglimin for the Treatment of Type 2 Diabetes in Japan and Successful Completion of the Pivotal TIMES Clinical Development Program sumitomo-pharma.com ↗
Imeglimin met its key efficacy endpoint of HbA1c reduction, demonstrating how its unique dual mechanism of action was observed to show added efficacy benefits in combination with existing hypoglycemic agents |
| 2019-06-25 | Sumitomo Pharma America, Inc. | Results Poxel and Sumitomo Dainippon Pharma Announce Second Positive Top-Line Results for Imeglimin Phase 3 Trial (TIMES 3) in Japan for the Treatment of Type 2 Diabetes sumitomo-pharma.com ↗
Imeglimin in combination with insulin Phase 3 TIMES 3 16-week, double-blind, placebo-controlled, randomized part of the trial met its primary endpoint with a favorable safety and tolerability profile |
| 2019-04-09 | Sumitomo Pharma America, Inc. | Results Poxel and Sumitomo Dainippon Pharma Announce Positive Top-Line Results for Imeglimin Phase 3 Trial (TIMES 1) in Japan for the Treatment of Type 2 Diabetes sumitomo-pharma.com ↗
Imeglimin Phase 3 trial (TIMES 1) met its primary and main secondary endpoints |
All press releases naming this drug 10 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imeglimin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01951235 ↗ |
| Known as | EMD-387008 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297514 ↗ |
| Known as | Imeglimina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297514 ↗ |
| Known as | Imeglimine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297514 ↗ |
| Known as | Twymeeg | “Imeglimin (Twymeeg)” NCT07436182 ↗ |
| Action | Activate | “enhances mitochondrial Complex I and III activity” NCT07436182 ↗ |
| Modality | Small molecule | — CHEMBL4297514 ↗ |
| Route | Oral | “Tablet, oral, single dose” NCT02924337 ↗ |