Drug Type Small molecule drug |
Synonyms Capivasertib (JAN/USAN), Capivastertib, AZ12952302 + [4] |
Target |
Mechanism Akt-1 inhibitors(Serine/threonine-protein kinase AKT inhibitors), Akt-2 inhibitors(Serine/threonine-protein kinase AKT2 inhibitors), Akt-3 inhibitors(Serine/threonine-protein kinase AKT3 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (16 Nov 2023), |
RegulationPriority Review (US) |
Molecular FormulaC21H25ClN6O2 |
InChIKeyJDUBGYFRJFOXQC-KRWDZBQOSA-N |
CAS Registry1143532-39-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
ER-positive/HER2-negative Breast Cancer | EU | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | IS | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | LI | 17 Jun 2024 | |
ER-positive/HER2-negative Breast Cancer | NO | 17 Jun 2024 | |
Hormone receptor positive HER2 negative breast cancer | US | 16 Nov 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic castration-resistant prostate cancer | Phase 3 | US | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | CN | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | JP | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | AU | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | BE | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | BR | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | CA | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | CL | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | CZ | 25 Mar 2022 | |
Metastatic castration-resistant prostate cancer | Phase 3 | FR | 25 Mar 2022 |
Phase 2 | 30 | (Relapsed or Refractory Follicular Lymphoma (R/R FL): Capivasertib Monotherapy) | rkdxaofupv(soqqyftgns) = dtluezumhn qyarncdeez (xeqqbyaizi, svjgfewvdw - flgpxbekht) View more | - | 20 Jun 2024 | ||
(Relapsed or Refractory Marginal Zone Lymphoma (R/R MZL): Capivasertib Monotherapy) | rkdxaofupv(soqqyftgns) = ankyhrvrwk qyarncdeez (xeqqbyaizi, zexfthdosb - mhqxugisgz) View more | ||||||
Phase 3 | Advanced Triple-Negative Breast Carcinoma PIK3CA | AKT1 | PTEN | 923 | fooplxkgyq(fsjvpkvkqf) = did not meet the dual primary endpoints of improvement in overall survival (OS) qcvhqmvpub (thexfrkwlt ) Not Met View more | Negative | 18 Jun 2024 | ||
paclitaxel in combination with placebo | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer HER2− defined as IHC 0, or 1+ or IHC2+/ISH- | 708 | hqalvuhpqc(mytcfwwvly) = Diarrhea with C-F was generally manageable, and discontinuations due to diarrhea were low (2.0%; n=7/355) kjuvdgfvsq (kbbtoamhfd ) View more | Positive | 05 Dec 2023 | ||
Placebo + Fulvestrant | |||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer PIK3CA | AKT1 | PTEN | 134 | gcplbyjzgn(yehortyazv) = hlnggudujh acecnygfeg (aocsjqliyh ) | Positive | 02 Dec 2023 | ||
Placebo + fulvestrant | gcplbyjzgn(yehortyazv) = myraonepzq acecnygfeg (aocsjqliyh ) | ||||||
Phase 3 | Hormone receptor positive HER2 negative breast cancer HER2 Negative | HR Positive | 708 | (PIK3CA/AKT1/PTEN-Altered Tumors) | yannemkdcf(csjqaqwiff) = wrkiacrjkx vbohyjpahl (nyxbbutkga ) View more | Positive | 16 Nov 2023 | |
placebo+fulvestrant (PIK3CA/AKT1/PTEN-Altered Tumors) | yannemkdcf(csjqaqwiff) = hltltsirgy vbohyjpahl (nyxbbutkga ) View more | ||||||
Phase 2 | 15 | mxspwirtma(lmllyghvrn) = aocleznxwt volfzalaui (omnkjwluhn ) | - | 08 Jun 2023 | |||
Phase 3 | 708 | wxkfkqftbp(reyifwbgwa) = Adverse events leading to discontinuation were reported in 13.0% of the patients receiving capivasertib and in 2.3% of those receiving placebo mpqzkhnxai (pfdjfmudzj ) View more | Positive | 01 Jun 2023 | |||
Phase 3 | Advanced breast cancer HR Positive | HER2 Positive | 705 | jlhrufyfxb(ohudleglmc) = Common AEs were diarrhea, rash, and hyperglycemia; maximum AE grade was mostly 1/2 and led to low rates of discontinuation. In the C+F arm, medications for the management of AEs were used in 151/257 pts (59%) with diarrhea (mostly loperamide; n=135), 109/135 pts (81%) with rash (mostly antihistamines; n=75/topical corticosteroids; n=64), and 28/60 pts (47%) with hyperglycemia (mostly metformin; n=18). maxncfcict (scvvbenbig ) | Positive | 31 May 2023 | ||
Placebo + Fulvestrant 500 mg | |||||||
Phase 2 | Metastatic endometrial cancer Maintenance | - | vsrbkqixow(ymsuureazh) = hobfswjwmx tonjhfvoeb (eyvlyhwhsl ) | - | 31 May 2023 | ||
Phase 3 | 708 | Capivasertib-fulvestrant | focvgzopsr(oqjohqtonw): HR = 0.6 (95% CI, 0.51 - 0.71) | Positive | 11 May 2023 | ||