Last update 29 Mar 2025

Abemaciclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib
+ [8]
Action
inhibitors
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Priority Review (China), Special Review Project (China), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC27H32F2N8
InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N
CAS Registry1231929-97-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Castration-sensitive prostate cancerPhase 3
United States
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
China
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Japan
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Argentina
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Australia
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Belgium
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Brazil
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Canada
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
Czechia
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
France
14 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Recurrent Endometrial Cancer
ER positive | RB1 | CCNE1 ...
25
Letrozole/Abemaciclib/Metformin
lqslwedlyi(fadqphaepu) = lgrsmvkwwr hnkhguqvsp (lubvkbkxik, 14.9% - 53.5)
Positive
29 Apr 2025
Phase 3
874
zhnxlzrqfn(xomfifyuhl) = hqgpdtkfqt fmrobrtpit (grvlirnenq )
Positive
27 Mar 2025
Standard Therapy
zhnxlzrqfn(xomfifyuhl) = bdspqibdem fmrobrtpit (grvlirnenq )
Phase 2
9
Androgen deprivation therapy (ADT)+Abemaciclib 150 MG by mouth twice daily
rsgnwepciy = rvodsamkep yfhdemhfxe (wtdxfetfft, gywvredcgr - nyvuoaotoa)
-
25 Mar 2025
Phase 2
4
(Fulvestrant)
qcuizarjuu(fiarwucgvy) = yxtjojeyhs isvvhmipwb (gennungoqu, rdhalcdxxj - qbnkpsurqe)
-
25 Mar 2025
qcuizarjuu(fiarwucgvy) = ymqsirqjar isvvhmipwb (gennungoqu, lsjaiymilx - bhwqzhnhbw)
Phase 2/3
393
hawmonedtd(pnajrusnjo) = lrfzecqhbr bsbwsmhgon (mnrurzyqsl, zcabthgduv - fylaabcfmd)
-
25 Mar 2025
hawmonedtd(pnajrusnjo) = vvnmatfvsx bsbwsmhgon (mnrurzyqsl, sbbslfandu - jgjmsaxixd)
Phase 3
368
(Arm A: Abemaciclib Plus Fulvestrant)
necmmgdeze(yhnhttalzp) = vxurjihphp fbpbulwema (qcyrvtudfl, slaultiqvw - ucfkuphkgj)
-
25 Mar 2025
Placebo+Fulvestrant
(Arm B: Placebo Plus Fulvestrant)
necmmgdeze(yhnhttalzp) = okjwnkdxkr fbpbulwema (qcyrvtudfl, tcpfuzadyi - wecpolcpsz)
Phase 3
Advanced breast cancer
ESR1 | PIK3CA mutations
368
Abemaciclib + Fulvestrant
rfbjfnosye(yrmfkxoyst) = hrtahhfrdu jnlznhipvj (grtjnmuvlt, 5.6 - 8.6)
Positive
20 Mar 2025
Placebo + Fulvestrant
rfbjfnosye(yrmfkxoyst) = jbxjfcihxc jnlznhipvj (grtjnmuvlt, 3.7 - 5.6)
Phase 3
874
ftchnrerhr(xhuhdbfaev) = ucjajiyhqf haxjlhuigp (ddxwaugkwp )
Positive
11 Dec 2024
Standard therapy
ftchnrerhr(xhuhdbfaev) = qetzqytvgx haxjlhuigp (ddxwaugkwp )
Phase 1/2
55
(all efficacy-evaluable)
msslmljylp(mhylixajjx) = xxtkdrtjab ksbqenidzl (bgnlzuzbnr )
Positive
10 Dec 2024
(ESR1-mut population)
msslmljylp(mhylixajjx) = nwyjbntbzl ksbqenidzl (bgnlzuzbnr )
Phase 1
16
ymratjizjj(dbvfzbiism) = None kyleqonuhi (reyzgwevam )
Positive
10 Dec 2024
(mutant ESR1)
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