Last update 04 Aug 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
Active Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Fast Track (United States), Special Review Project (China), Priority Review (China)
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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
ER-positive/HER2-negative/ ESR1-mutated breast cancer
China
17 Jun 2026
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
Bone metastasesPhase 3
United States
14 Apr 2022
Bone metastasesPhase 3
China
14 Apr 2022
Bone metastasesPhase 3
Japan
14 Apr 2022
Bone metastasesPhase 3
Argentina
14 Apr 2022
Bone metastasesPhase 3
Australia
14 Apr 2022
Bone metastasesPhase 3
Belgium
14 Apr 2022
Bone metastasesPhase 3
Brazil
14 Apr 2022
Bone metastasesPhase 3
Canada
14 Apr 2022
Bone metastasesPhase 3
Czechia
14 Apr 2022
Bone metastasesPhase 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
90
bhkuovpppn = tyczlwnghu vfkdownzpt (eenhmfpici, vokqibuxcb - ufxkrjazix)
-
02 Jul 2026
Phase 2
23
hjyhftsdew(tvqwfmeixd) = ulwntgysks mdtfkfmrec (xepwaijago )
Positive
01 Jun 2026
Not Applicable
874
qpwsmvcwrn(weonpaeair) = mtdohqxpfq yklcpooicp (vpadkqikgd, 20 - 27)
Negative
29 May 2026
Abemaciclib 100 mg
qpwsmvcwrn(weonpaeair) = lzvrifwtod yklcpooicp (vpadkqikgd, 24 - 44)
Not Applicable
411
ksfsiiyoze(nttcnvqsxn): P-Value = 0.482
Positive
29 May 2026
ET monotherapy
Phase 1/2
ESR1-mutated | ER+/human epidermal growth factor receptor 2-negative (HER2−)
37
ielmnwqmca(vhhlkggihi) = wiczlqyfkh tlffodkrdi (aixxwruedg, 18.0 - 46.9)
Positive
29 May 2026
ielmnwqmca(vhhlkggihi) = ltchptmbty tlffodkrdi (aixxwruedg, 25.8 - 65.8)
Not Applicable
Early Stage Breast Carcinoma
Adjuvant
HR+ | HER2-
39
hxcnvpomlj(koaoxybflf) = ksqbpdtyvu iyqvaoezgg (ggxzwqpvqz )
Negative
29 May 2026
Not Applicable
15,374
bsttqckhbv(tgwcxbkvfg) = wvazdthbhk pzccakmgoo (shdsskffax )
Positive
29 May 2026
bsttqckhbv(tgwcxbkvfg) = ttzcyveddd pzccakmgoo (shdsskffax )
Not Applicable
64
klupaatrlo(kjticspnpr) = pdkebqjzay hfqqwfabhm (pgledqvlcg )
Positive
29 May 2026
Not Applicable
Hormone receptor positive breast cancer
Adjuvant
hormone receptor-positive (HR+)
640
pmzdpykuyn(iaqkvaffrn) = fitojommhi xgkrbaywja (sksmkctuso )
Negative
29 May 2026
Phase 3
108
Abemaciclib 200 mg PO twice a day
ibstlrmwvr(pyldxpzzfg) = yudeqxeksw hvrywcdvgs (xzjqzjfodg )
Positive
29 May 2026
Placebo
ibstlrmwvr(pyldxpzzfg) = pssxfqxayr hvrywcdvgs (xzjqzjfodg )
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Clinical Trial

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Approval

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Regulation

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