Drug Type Small molecule drug |
Synonyms Risovalisib mesilate hydrate, Risovalisib mesylate dihydrate, CYH-33 + [4] |
Target |
Action inhibitors |
Mechanism PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationOrphan Drug (Japan) |
Molecular FormulaC25H33F3N8O8S2 |
InChIKeyCYWUJTNXNJVGLY-UHFFFAOYSA-N |
CAS Registry1494684-33-1 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Ovarian clear cell carcinoma | NDA/BLA | Japan | 15 Aug 2025 | |
PIK3CA-related overgrowth syndrome | Phase 2 | China | 10 Aug 2023 | |
PIK3CA-related vascular malformations | Phase 2 | China | 10 Aug 2023 | |
Fallopian Tube Clear Cell Adenocarcinoma | Phase 2 | China | 12 Jul 2022 | |
Fallopian Tube Clear Cell Adenocarcinoma | Phase 2 | China | 12 Jul 2022 | |
Primary clear cell peritoneal carcinoma | Phase 2 | China | 13 Aug 2021 | |
Primary clear cell peritoneal carcinoma | Phase 2 | Japan | 13 Aug 2021 | |
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer | Phase 1 | China | 09 Jul 2021 | |
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer | Phase 1 | Australia | 09 Jul 2021 | |
Advanced breast cancer | Phase 1 | - | 01 Apr 2021 |
Phase 2 | - | zceqmozlmr(pyswuzymiv) = 本次适应症的上市许可申请主要基于CYH33-G201关键II期研究的有效性和安全性数据。 enllfktupk (ggqergiwly ) | Positive | 15 Aug 2025 | |||
NCT04856371 (ASCO2024) Manual | Phase 1 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer HER2 Negative | PIK3CA Mutation | HR Positive | 52 | dvessbfzva(rywjvlgymi) = CYH33 30mg QD + Fulvestrant 500mg hkcuojvclo (wsrzekdncv ) View more | Positive | 24 May 2024 | |
(PIK3CA-mutations without prior fulvestrant treatment) | |||||||
NCT03544905 (Pubmed) Manual | Phase 1 | PIK3CA H1047R mutant Solid Tumors PIK3CA Mutation | 51 | (overall) | jebgdhtjrf(mdejigfewz) = iodejhoqur pxzbtmmuxh (acgzsywvzn ) View more | Positive | 16 Nov 2022 |
(patients with PIK3CA mutations) | xtpnlkqjda(rncdlniksi) = eolkzmshzq bkpjlonwjz (ogllpoufob ) |