Drug Type Small molecule drug |
Synonyms + [1] |
Target |
Action inhibitors |
Mechanism DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date China (18 Jun 2024), |
RegulationSpecial Review Project (China) |
Molecular FormulaC18H19F5N4O3S |
InChIKeyGUBOXFWNNXSQNH-SVGFKBNWSA-N |
CAS Registry1844874-26-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diabetes Mellitus, Type 2 | China | 18 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Renal Insufficiency | Preclinical | China | 04 Aug 2022 | |
Glucose Intolerance | Preclinical | China | 19 Mar 2021 |
NCT04727580 (Pubmed) Manual | Phase 2 | 99 | cofrogliptin 10 mg | (qhnwzoevdx) = lkccqsypry kobvmwyshb (nxzvapvmbl ) | Positive | 01 Feb 2025 | |
cofrogliptin 25 mg | (qhnwzoevdx) = mdneoteekm kobvmwyshb (nxzvapvmbl ) | ||||||
Phase 3 | - | (tclgjlskgx) = mpuqpsxepn mfphxcoqwy (vwpixatkzy, -1.08 to -0.83) | Positive | 03 Oct 2023 | |||
HSK7653 25mg | (tclgjlskgx) = atpmtohtqo mfphxcoqwy (vwpixatkzy, -1.12 to -0.87) | ||||||
Not Applicable | 475 | (bgcyrouxoo) = gwiinjcswd rabjghkxvb (qemrsoipae ) | Positive | 20 Jun 2023 | |||
HSK7653 25mg | (bgcyrouxoo) = nzppahvvxl rabjghkxvb (qemrsoipae ) | ||||||
NCT04564872 (NEWS) Manual | Phase 3 | 450 | Metformin+HSK 7653 | (czuonwqnhb) = 两个剂量组均能有效降低患者糖化 血红蛋白,且每两周服用一次 HSK7653 片与每天服用一次阳性对照药 利格列汀片的降幅相当 hbmxvtjgxl (vbxhvpluzd ) | Non-inferior | 25 Aug 2022 | |
Metformin+Linagliptin | |||||||
NCT04556851 (NEWS) Manual | Phase 3 | 462 | (aakxjrcnjx) = HSK7653 片的两个剂量组均达到了临床终点,均能有效降低 2 型糖尿 病患者的糖化血红蛋白,且显著优于安慰剂组,安全性与安慰剂类似 dtyumeywkh (masjpemyeu ) | Positive | 25 Aug 2022 | ||
Placebo |