Drugs / Trelagliptin
Trelagliptin
also known as
SYR-472 · SYR-111472 SUCCINATE · Trelagliptin Succinate · Trelagliptina · Trelagliptine · Zafatek
Small molecule targets DPP4 via inhibition
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 | 2014-03-07 | “it has submitted a New Drug Application ("NDA") to the Japanese Ministry of Health, Labour and Welfare” takeda.com ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00653185 | May 2007 → Mar 2008 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00760344 | Mar 2007 → Mar 2008 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT07073768 | Jul 2025 → Dec 2026 expected | type 2 diabetes mellitus | Khyber Medical College, Peshawar | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT03940183 | Jul 2019 → Dec 2020 | type 2 diabetes mellitus | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02512068 | Aug 2015 → Apr 2018 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT02324569 | Dec 2014 → Dec 2016 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01751360 | Apr → Aug 2013 | diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01632007 | May 2012 → Jul 2013 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01431807 | Sep 2011 → Jun 2013 | diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT04374864 | Mar → Jun 2020 | diabetes mellitus | British University In Egypt | Unknown | No outcome recorded |
| Phase 4 | NCT03231709 | Aug 2017 → Feb 2018 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 4 | NCT03014479 | Feb → Oct 2017 | type 2 diabetes mellitus | Takeda | Completed | Missed primary |
| Phase 4 | NCT02771093 | Sep 2016 → Apr 2017 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06889909 | Dec 2024 → Jun 2025 overdue | type 2 diabetes mellitus | Lahore General Hospital | Active not recruiting | No outcome recorded |
| — | NCT06913101 | Nov 2024 → May 2025 overdue | type 2 diabetes mellitus | PNS Hafeez - Naval Hospital | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT02528019 Comparator | Aug 2015 → Aug 2017 | — | Kurume University | Unknown | No outcome recorded |
| — | 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 · 3
| Date | Issuer | Release |
|---|---|---|
| 2015-03-26 | Takeda | Regulatory New Drug Application Approval of Zafatek ® Tablets for the treatment of Type 2 Diabetes in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek ® (generic name: trelagliptin succinate), a drug for treating type 2 diabetes. |
| 2014-09-17 | Takeda | Results Takeda Announces the Results of Phase 3 Trial of Trelagliptin Succinate (SYR-472) for the Treatment of Type 2 Diabetes Mellitus at the 50th EASD Annual Meeting takeda.com ↗ |
| 2014-03-07 | Takeda | Regulatory Takeda Submits a New Drug Application for Trelagliptin Succinate (SYR-472) in Japan for the Treatment of Type 2 Diabetes takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has submitted a New Drug Application ("NDA") to the Japanese Ministry of Health, Labour and Welfare fortrelagliptin succinate (development code: SYR-472), a treatment for type 2 diabetes. |
All press releases naming this drug 5 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trelagliptin | “trelagliptin (50-100mg weekly)” NCT02528019 ↗ |
| Known as | SYR-111472 SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1650443 ↗ |
| Known as | SYR-472 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02324569 ↗ |
| Known as | Trelagliptin Succinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03940183 ↗ |
| Known as | Trelagliptina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1650443 ↗ |
| Known as | Trelagliptine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1650443 ↗ |
| Known as | Zafatek | ChEMBL registry synonym — accepted as the source's own label CHEMBL1650443 ↗ |
| Action | Inhibit | “selective inhibitor of dipeptidyl peptidase-4” NCT00653185 ↗1“Dipeptidyl peptidase IV inhibitor” CHEMBL1650443 ↗ |
| Modality | Small molecule | — CHEMBL1650443 ↗ |
| Route | Oral | “orally” NCT00653185 ↗ |
| Target | DPP4 | “Dipeptidyl peptidase IV inhibitor” CHEMBL1650443 ↗ |