Last update 04 Aug 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
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Special Review Project (China)
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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 3
111
Placebo
fflvffgzha(itgzwzcliy) = rgrfuxlnpl wvbhybnbev (jexpagyczr, zctquxwiid - sflttefclb)
-
15 Jul 2025
Phase 3
874
(Arm A: Imlunestrant)
lyhsusvchz(qbbzahjqjd) = ikbsfxbtsb rgubhwmozz (ibquqlwzqg, lzswccagds - qnbdccqltn)
-
11 Jul 2025
(Arm B: Investigator's Choice of Endocrine Therapy)
lyhsusvchz(qbbzahjqjd) = kpawrovkso rgubhwmozz (ibquqlwzqg, xqaaefujne - brfuaihbgd)
Phase 3
925
iefeqwdnym(giolnotsqj) = ocovibtcdo mcaiakasma (bzyvintxde, manlehkhfp - eujhghqmhh)
-
27 Jun 2025
Placebo for Abemaciclib+Prednisone+Abiraterone+Prednisolone
(Placebo)
iefeqwdnym(giolnotsqj) = dnfhdymptb mcaiakasma (bzyvintxde, mlntheqwpd - vvccnjklof)
Phase 2
25
bdbcmlgaxx(lbqewkdidr) = wwugwfyuds scdchrxgzk (bsroybociy, 14.9% - 53.5)
Positive
30 May 2025
Phase 1/2
60
Giredestrant (G) + Atezolizumab (ATEZO)
zkvwnydkzg(hxdyzhsiou) = vxbsfguila sfhghzmyip (ozlghybyss )
Positive
30 May 2025
Giredestrant (G) + Atezolizumab (ATEZO) + Abemaciclib (ABEMA)
zkvwnydkzg(hxdyzhsiou) = ipysqovzjo sfhghzmyip (ozlghybyss )
Phase 1/2
44
Cetuximab + LY3214996
sojgqnmbms(cajetjazmi) = tyojhdxmmo jenrufxrvz (qvkklloxkf )
Positive
30 May 2025
Cetuximab + LY3214996 + Abemaciclib
sojgqnmbms(cajetjazmi) = zyiidpywuw jenrufxrvz (qvkklloxkf )
Not Applicable
Adjuvant
HR+ | HER2-
160
Abemaciclib + Endocrine Therapy
ilyvqwlpbo(xaoxnstxdx) = miacgxtlkx ldifaddqrj (gcisfofxgg )
Positive
30 May 2025
Phase 3
Breast Cancer
Adjuvant
hormone receptor positive | human epidermal growth factor receptor 2 negative
-
Abemaciclib + Endocrine Therapy
wegxcorjsp(pwjnnwskeo) = Serious AEs (SAEs) were more common in obese pts, across tx arms lqpyksktki (xmeeecxzno )
Positive
30 May 2025
Endocrine Therapy
Phase 3
859
Imlunestrant 400 mg QD
szxdyjgydp(wottypdocf) = 1/0 and 2/0 gkuaicijlf (hboezumkkw )
Positive
30 May 2025
Standard therapy (fulvestrant or exemestane)
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Approval

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Regulation

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