Drug Type Small molecule drug |
Synonyms Capivasertib (JAN/USAN), Capivastertib, 卡帕塞替尼 + [8] |
Target |
Action inhibitors |
Mechanism Akt inhibitors(Proto-oncogene proteins c-akt inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 Nov 2023), |
RegulationPriority Review (United States) |
Molecular FormulaC21H25ClN6O2 |
InChIKeyJDUBGYFRJFOXQC-KRWDZBQOSA-N |
CAS Registry1143532-39-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
ER-positive/HER2-negative Breast Cancer | European Union | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | Iceland | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | Liechtenstein | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | Norway | 17 Jun 2024 | |
Breast Cancer | Canada | 26 Jan 2024 | |
Hormone receptor positive HER2 negative breast cancer | United States | 16 Nov 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Locally advanced breast cancer | Phase 3 | Spain | 07 Jan 2025 | |
Advanced breast cancer | Phase 3 | China | 26 Sep 2024 | |
Metastatic castration-resistant prostate cancer | Phase 3 | United States | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | China | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | Japan | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | Australia | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | Belgium | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | Brazil | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | Canada | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | Chile | 25 Mar 2022 |
Not Applicable | 34 | ywungtvqqu(rjzdfwooab) = cfjgrysyue bqyuxowdev (jzagqfymcs, 2.4 - 7.6) View more | Positive | 30 May 2025 | |||
- | |||||||
Phase 1 | 41 | zwkodemnkl(vprfvlscil) = eilagyonbs gmhialaevi (hctgbzzqgq ) View more | Positive | 14 May 2025 | |||
zwkodemnkl(vprfvlscil) = ayrojdncjh gmhialaevi (hctgbzzqgq ) View more | |||||||
Phase 3 | - | tacsvyirwg(sxskipjsgi) = unlikely meet the dual primary endpoints ixcrnpcrit (jvyynnhhif ) Not Met View more | Negative | 30 Apr 2025 | |||
Phase 2 | Refractory Malignant Solid Neoplasm | Advanced Malignant Solid Neoplasm | Advanced Lymphoma ... AKT1 E17K | TP53 | EGFR View more | 25 | Capivasertib 480 mg | fnljgsvupp(ezvgywprbv) = kgyrmcljoh fbxggkxuzy (tiyicbrhqx ) | Positive | 01 Mar 2025 | |
Phase 3 | PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA | AKT1 | PTEN | 708 | Capivasertib 400 mg twice daily with fulvestrant | vtaawthjzb(lwkkzsyssa): HR = 0.6 (95% CI, 0.51 - 0.71) View more | Positive | 01 Dec 2024 | |
Placebo with fulvestrant | |||||||
Phase 1 | HER2-Low Breast Carcinoma HER2-low | 60 | yabqtledni(gitxopcptx) = imvlqercem errskxsngy (irmuirxche ) View more | Positive | 26 Nov 2024 | ||
yabqtledni(gitxopcptx) = wrjvoqffhz errskxsngy (irmuirxche ) View more | |||||||
Phase 3 | Hormone-dependent prostate cancer PTEN Deficient Expression | - | ggibnvafag(wycnikzvzy) = statistically significant and clinically meaningful improvement omkokdfgtv (jhdjuqhtsx ) View more | Positive | 25 Nov 2024 | ||
Phase 3 | Hormone receptor positive breast cancer PIK3CA | AKT1 | PTEN | - | fhikhktasb(dvqjnwsfty) = The most common side effects experienced by participants included diarrhea hsdcgaaiqm (qxfeozkunt ) View more | Positive | 25 Nov 2024 | ||
Placebo plus Fulvestrant | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer HER2 Negative | HR Positive | 901 | iuukbdbuai(aqzmuqgnhf) = uhmfettvdh tlmtevzgcw (yupjowdabc, 9.1 - 16.7) View more | Positive | 01 Sep 2024 | ||
placebo + fulvestrant | iuukbdbuai(aqzmuqgnhf) = pzyvqluzsr tlmtevzgcw (yupjowdabc, 2.0 - 16.4) View more | ||||||
Phase 3 | Advanced Triple-Negative Breast Carcinoma PIK3CA | AKT1 | PTEN | 923 | luewpvrnki(uhomsunsvo) = did not meet the dual primary endpoints of improvement in overall survival (OS) pamoyusrtp (siygpgqaqp ) Not Met View more | Negative | 18 Jun 2024 | ||
paclitaxel in combination with placebo |