Drug Type Small molecule drug |
Synonyms Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib + [8] |
Target |
Action inhibitors |
Mechanism CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Sep 2017), |
RegulationFast Track (United States), Priority Review (China), Special Review Project (China), Breakthrough Therapy (United States) |
Molecular FormulaC27H32F2N8 |
InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N |
CAS Registry1231929-97-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10688 | Abemaciclib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Advanced breast cancer | Canada | 08 Apr 2019 | |
Metastatic breast cancer | Canada | 08 Apr 2019 | |
HR Positive/HER2 Negative/Node positive breast cancer | European Union | 26 Sep 2018 | |
HR Positive/HER2 Negative/Node positive breast cancer | Iceland | 26 Sep 2018 | |
HR Positive/HER2 Negative/Node positive breast cancer | Liechtenstein | 26 Sep 2018 | |
HR Positive/HER2 Negative/Node positive breast cancer | Norway | 26 Sep 2018 | |
Hormone receptor positive HER2 negative breast cancer | United States | 28 Sep 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Castration-sensitive prostate cancer | Phase 3 | United States | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | China | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Japan | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Argentina | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Australia | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Belgium | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Brazil | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Canada | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Czechia | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | France | 14 Apr 2022 |
Phase 2 | 25 | Letrozole/Abemaciclib/Metformin | lqslwedlyi(fadqphaepu) = lgrsmvkwwr hnkhguqvsp (lubvkbkxik, 14.9% - 53.5) View more | Positive | 29 Apr 2025 | ||
Phase 3 | 874 | zhnxlzrqfn(xomfifyuhl) = hqgpdtkfqt fmrobrtpit (grvlirnenq ) View more | Positive | 27 Mar 2025 | |||
Standard Therapy | zhnxlzrqfn(xomfifyuhl) = bdspqibdem fmrobrtpit (grvlirnenq ) View more | ||||||
Phase 2 | 9 | Androgen deprivation therapy (ADT)+Abemaciclib 150 MG by mouth twice daily | rsgnwepciy = rvodsamkep yfhdemhfxe (wtdxfetfft, gywvredcgr - nyvuoaotoa) View more | - | 25 Mar 2025 | ||
Phase 2 | 4 | (Fulvestrant) | qcuizarjuu(fiarwucgvy) = yxtjojeyhs isvvhmipwb (gennungoqu, rdhalcdxxj - qbnkpsurqe) View more | - | 25 Mar 2025 | ||
(Continuing AI After Randomization) | qcuizarjuu(fiarwucgvy) = ymqsirqjar isvvhmipwb (gennungoqu, lsjaiymilx - bhwqzhnhbw) View more | ||||||
Phase 2/3 | 393 | (Abemaciclib) | hawmonedtd(pnajrusnjo) = lrfzecqhbr bsbwsmhgon (mnrurzyqsl, zcabthgduv - fylaabcfmd) View more | - | 25 Mar 2025 | ||
(Placebo) | hawmonedtd(pnajrusnjo) = vvnmatfvsx bsbwsmhgon (mnrurzyqsl, sbbslfandu - jgjmsaxixd) View more | ||||||
Phase 3 | 368 | (Arm A: Abemaciclib Plus Fulvestrant) | necmmgdeze(yhnhttalzp) = vxurjihphp fbpbulwema (qcyrvtudfl, slaultiqvw - ucfkuphkgj) View more | - | 25 Mar 2025 | ||
Placebo+Fulvestrant (Arm B: Placebo Plus Fulvestrant) | necmmgdeze(yhnhttalzp) = okjwnkdxkr fbpbulwema (qcyrvtudfl, tcpfuzadyi - wecpolcpsz) View more | ||||||
Phase 3 | Advanced breast cancer ESR1 | PIK3CA mutations | 368 | Abemaciclib + Fulvestrant | rfbjfnosye(yrmfkxoyst) = hrtahhfrdu jnlznhipvj (grtjnmuvlt, 5.6 - 8.6) View more | Positive | 20 Mar 2025 | |
Placebo + Fulvestrant | rfbjfnosye(yrmfkxoyst) = jbxjfcihxc jnlznhipvj (grtjnmuvlt, 3.7 - 5.6) View more | ||||||
Phase 3 | 874 | ftchnrerhr(xhuhdbfaev) = ucjajiyhqf haxjlhuigp (ddxwaugkwp ) View more | Positive | 11 Dec 2024 | |||
Standard therapy | ftchnrerhr(xhuhdbfaev) = qetzqytvgx haxjlhuigp (ddxwaugkwp ) View more | ||||||
Phase 1/2 | ER-positive/HER2-negative Breast Cancer HER2 Negative | 55 | (all efficacy-evaluable) | msslmljylp(mhylixajjx) = xxtkdrtjab ksbqenidzl (bgnlzuzbnr ) | Positive | 10 Dec 2024 | |
(ESR1-mut population) | msslmljylp(mhylixajjx) = nwyjbntbzl ksbqenidzl (bgnlzuzbnr ) | ||||||
Phase 1 | ER-positive/HER2-negative Breast Cancer Third line | 16 | ymratjizjj(dbvfzbiism) = None kyleqonuhi (reyzgwevam ) View more | Positive | 10 Dec 2024 | ||
(mutant ESR1) |