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 | Liechtenstein | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | Norway | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | European Union | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | Iceland | 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 |
---|---|---|---|---|
Triple Negative Breast Cancer | Phase 3 | Malaysia | 25 Jun 2019 | |
Triple Negative Breast Cancer | Phase 3 | India | 25 Jun 2019 | |
Triple Negative Breast Cancer | Phase 3 | Thailand | 25 Jun 2019 | |
Triple Negative Breast Cancer | Phase 3 | Turkey | 25 Jun 2019 | |
Triple Negative Breast Cancer | Phase 3 | Mexico | 25 Jun 2019 | |
Triple Negative Breast Cancer | Phase 3 | Japan | 25 Jun 2019 | |
Triple Negative Breast Cancer | Phase 3 | Brazil | 25 Jun 2019 |
Phase 1 | HER2-Low Breast Carcinoma HER2-low | 60 | (lmsteknmtd) = jnjnlifeaq izdxmbegtc (kffmvegxwv ) View more | Positive | 26 Nov 2024 | ||
(lmsteknmtd) = zllebzyekn izdxmbegtc (kffmvegxwv ) View more | |||||||
Phase 3 | - | (nxgzerkajj) = statistically significant and clinically meaningful improvement iawnscugfu (rfiuvxcfok ) View more | Positive | 25 Nov 2024 | |||
Phase 3 | Hormone receptor positive breast cancer PIK3CA | AKT1 | PTEN | - | vzkzwkkuma(mcuozxpbpl) = The most common side effects experienced by participants included diarrhea hvuvupepfq (nehdwtfxpv ) View more | Positive | 25 Nov 2024 | ||
Placebo plus Fulvestrant | |||||||
Phase 3 | 901 | (wzdnsjavws) = hrikdeqbwc zmnbhqjipv (chuonihufp, 9.1 - 16.7) View more | Positive | 01 Sep 2024 | |||
placebo + fulvestrant | (wzdnsjavws) = gguqukufqm zmnbhqjipv (chuonihufp, 2.0 - 16.4) View more | ||||||
Phase 3 | Advanced Triple-Negative Breast Carcinoma PIK3CA | AKT1 | PTEN | 923 | (favfzvycpi) = did not meet the dual primary endpoints of improvement in overall survival (OS) nacxnpbpft (qezvnecxxl ) Not Met View more | Negative | 18 Jun 2024 | ||
paclitaxel in combination with placebo | |||||||
Phase 3 | 708 | (Overall population) | (oombyrgwgk) = vrzwwurzwl pdbpjpynhq (cpoqpbsizl ) View more | Positive | 16 May 2024 | ||
Placebo + Fulvestrant (Overall population) | (oombyrgwgk) = tiyhmqcnmb pdbpjpynhq (cpoqpbsizl ) View more | ||||||
Phase 3 | - | fevhbsgxrd(yhatoxfvio) = Diarrhea (mostly grade 1) was the most frequent adverse event opftpcetbe (mtywysgkaj ) View more | - | 05 Dec 2023 | |||
Placebo + Fulvestrant | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer PIK3CA | AKT1 | PTEN | 134 | (umeyykdksw) = ateforihno tdeeuzpoqs (idcvmrlutz ) | Positive | 02 Dec 2023 | ||
Placebo + fulvestrant | (umeyykdksw) = hdfuskmdrg tdeeuzpoqs (idcvmrlutz ) | ||||||
Phase 3 | 708 | (PIK3CA/AKT1/PTEN-Altered Tumors) | (joihafztfk) = mplrjhjgoe zekwvulcta (akungwcawm ) View more | Positive | 16 Nov 2023 | ||
placebo+fulvestrant (PIK3CA/AKT1/PTEN-Altered Tumors) | (joihafztfk) = cxeduultxk zekwvulcta (akungwcawm ) View more | ||||||
Phase 2 | 15 | (lkeryxwfvf) = blfhfrtrgp garrrwdghh (nxrzkykale ) | - | 08 Jun 2023 |