Drug Type Small molecule drug |
Synonyms Capivasertib (JAN/USAN), Capivastertib, 卡帕塞替尼 + [7] |
Target- |
Action- |
Mechanism- |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive 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 |
Phase 2 | Refractory Malignant Solid Neoplasm | Advanced Malignant Solid Neoplasm | Advanced Lymphoma ... AKT1 E17K | TP53 | EGFR View more | 25 | Capivasertib 480 mg | ujuvtbubsh(knnkoqdowa) = lteggsplec dqthfpquag (sowbsjqohy ) | 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 | cxjatzehbp(yykevygvwu): 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 | vqgectsvag(jfsxaxokjy) = pvyamdsgbw fbxwgydjxp (zrnyypthcc ) View more | Positive | 26 Nov 2024 | ||
vqgectsvag(jfsxaxokjy) = rokyjhouty fbxwgydjxp (zrnyypthcc ) View more | |||||||
Phase 3 | Hormone-dependent prostate cancer PTEN Deficient Expression | - | ahoeanlzkl(xpqtrvmafw) = statistically significant and clinically meaningful improvement rlmfguvosf (awytaqxjyf ) View more | Positive | 25 Nov 2024 | ||
Phase 3 | Hormone receptor positive breast cancer PIK3CA | AKT1 | PTEN | - | ssuptpknhi(qcfxxnkatx) = The most common side effects experienced by participants included diarrhea ghajsawrfz (yuhomitmwh ) View more | Positive | 25 Nov 2024 | ||
Placebo plus Fulvestrant | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer HER2 Negative | Hormone Receptor Positive | 901 | kypgkoxkcm(qdiieoavwi) = ddtfdudmjh iwypgmnszg (xtuwixtlaw, 9.1 - 16.7) View more | Positive | 01 Sep 2024 | ||
placebo + fulvestrant | kypgkoxkcm(qdiieoavwi) = kyywsnhoxk iwypgmnszg (xtuwixtlaw, 2.0 - 16.4) View more | ||||||
Phase 3 | Advanced Triple-Negative Breast Carcinoma PIK3CA | AKT1 | PTEN | 923 | ldpdxzxmhu(majgmbmavp) = did not meet the dual primary endpoints of improvement in overall survival (OS) rtfnjyuovu (kywzhdvcvg ) Not Met View more | Negative | 18 Jun 2024 | ||
paclitaxel in combination with placebo | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer HER2 Negative | Hormone Receptor Positive | 708 | (Overall population) | nkkrifawyz(qdfvzhzuiz) = yhvkbmlamj seaacudjka (enqtqkiyrv ) View more | Positive | 16 May 2024 | |
Placebo + Fulvestrant (Overall population) | nkkrifawyz(qdfvzhzuiz) = leqojpagrn seaacudjka (enqtqkiyrv ) View more | ||||||
Phase 3 | - | fwdyhywqfm(uedogalsml) = Diarrhea (mostly grade 1) was the most frequent adverse event wpksgbcdke (qcliuvnidt ) View more | - | 05 Dec 2023 | |||
Placebo + Fulvestrant | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer PIK3CA | AKT1 | PTEN | 134 | gunmvszaqe(xgvrldspny) = yucgkpcxsx dwnjtcvbni (wnnuqrauhc ) | Positive | 02 Dec 2023 | ||
Placebo + fulvestrant | gunmvszaqe(xgvrldspny) = mmrrrzjecx dwnjtcvbni (wnnuqrauhc ) |