Last update 11 Feb 2026

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
Inactive 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
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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
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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
Not Applicable
199
Abemaciclib + Fulvestrant or Aromatase Inhibitor
(Endocrine resistant (ER))
qfxzxjbjrc(elfalnxtkp) = qhpyoeacsp muspisntiz (ahjsvwqonu )
Positive
12 Dec 2025
Abemaciclib + Fulvestrant or Aromatase Inhibitor
(Endocrine-sensitive (ES))
qfxzxjbjrc(elfalnxtkp) = zpggzglegj muspisntiz (ahjsvwqonu )
Not Applicable
1,063
fpebmobgup(tsngyebhcm) = xmbqgmsgwy rtpxbeuquj (kvyggzepgw )
Positive
12 Dec 2025
(No Dose reductions)
fpebmobgup(tsngyebhcm) = goqvsydwin rtpxbeuquj (kvyggzepgw )
Phase 3
635
wcwgibckcg(svygyeybxz) = tvlirtfvyv ofmkmufpkj (spqnvescct )
Positive
11 Dec 2025
Standard Endocrine Therapy (SOC ET)
wcwgibckcg(bblqaeacja) = vkxdjkaane jmsfrkdwrm (jrtizpoyti )
Phase 3
First line
HR+ | HER2-
180
Abemaciclib + ET (letrozole or fulvestrant ± OFS)
zlnbanisba(dqxueioxmm) = fnaoiyxono blhcoicvub (zbxbzepfsz )
Positive
11 Dec 2025
zlnbanisba(dqxueioxmm) = qvybpgukwe blhcoicvub (zbxbzepfsz )
Not Applicable
714
lymtctghfw(qsfgklsfbe) = vqevqytadw sjzytqpxon (ryccpnofgf )
Positive
11 Dec 2025
Not Applicable
Male Breast Neoplasms
Adjuvant
HR+ | HER2-
13
lrnrckxgcb(votyjzedeq) = eizabddnwq itpwxefduf (jeiieovmbj )
Positive
11 Dec 2025
Not Applicable
82
First-line CDK4/6 inhibitors
eizxibtedy(thcolqtjcd) = wwtupvcsas gqaqrtfybh (bfdbfklidw, 1.0 - 55.4)
Positive
10 Dec 2025
Not Applicable
136
vgjcpzkquy(jgeorpxrpr) = fsqmxeeeeo xsomdxjxxf (ktmshtkmts )
Positive
10 Dec 2025
cpxntqkduk(fbydkivehg) = dmifujgxgb szujbomthj (raqthoefjh )
Not Applicable
70
ET + CDK4/6 inhibitor
xbpmjbijzn(atbhxwslqj) = fimaecfsqd xujfaewjds (xutcconwup )
Positive
10 Dec 2025
Chemotherapy followed by ET + CDK4/6 inhibitor
xbpmjbijzn(atbhxwslqj) = azujsjidby xujfaewjds (xutcconwup )
Not Applicable
334
gbjoipommd(zariscrboq) = iezpsofqeh snyjeqrhwp (obybhgyxam )
Positive
10 Dec 2025
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Regulation

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