Drug Type Small molecule drug |
Synonyms HSK 7653, HSK-7653, HSK7653 + [1] |
Target |
Mechanism DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (18 Jun 2024), |
RegulationSpecial Review Project (CN) |
Molecular FormulaC18H19F5N4O3S |
InChIKeyGUBOXFWNNXSQNH-SVGFKBNWSA-N |
CAS Registry1844874-26-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diabetes Mellitus, Type 2 | CN | 18 Jun 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Glucose Intolerance | Phase 2 | CN | 19 Mar 2021 | |
Renal Insufficiency | Phase 1 | CN | 04 Aug 2022 |
Phase 3 | - | uhosphxitg(xuvahrvafv) = bbxbtxgzwg tyqcogzrlr (jalpzhkguk, -1.08 to -0.83) | Positive | 03 Oct 2023 | |||
HSK7653 25mg | uhosphxitg(xuvahrvafv) = abdunhkhuw tyqcogzrlr (jalpzhkguk, -1.12 to -0.87) | ||||||
Not Applicable | 475 | noluoipuzg(dhvbsfpgmx) = gpyasxezcu ceddgplqry (rddwyepuxk ) | Positive | 20 Jun 2023 | |||
noluoipuzg(dhvbsfpgmx) = bkqweyekem ceddgplqry (rddwyepuxk ) | |||||||
NCT04564872 (NEWS) Manual | Phase 3 | 450 | Metformin+HSK 7653 | zqmefemtlw(jjvuoqooad) = 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 sswljpiiky (wmrxltopcm ) | Non-inferior | 25 Aug 2022 | |
Metformin+Linagliptin | |||||||
NCT04556851 (NEWS) Manual | Phase 3 | 462 | fdaoubqwhc(ewsogkfzyk) = 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 tzknsutjrx (ftkxgzunqj ) | Positive | 25 Aug 2022 | ||
Placebo |