Last update 25 Jun 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
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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 1/2
44
Cetuximab + LY3214996
txkxnftift(tbspbljfug) = imrvmeppxp ynmupofcnz (igqdjvmaep )
Positive
30 May 2025
Cetuximab + LY3214996 + Abemaciclib
txkxnftift(tbspbljfug) = zptoeycxis ynmupofcnz (igqdjvmaep )
Phase 3
Breast Cancer
Adjuvant
hormone receptor positive | human epidermal growth factor receptor 2 negative
-
Abemaciclib + Endocrine Therapy
qhwfmzahdz(ustrrefpty) = Serious AEs (SAEs) were more common in obese pts, across tx arms dgovycoyyb (rurbtkhcur )
Positive
30 May 2025
Endocrine Therapy
Phase 1/2
60
Giredestrant (G) + Atezolizumab (ATEZO)
jwuzdopzco(sfhjbinesz) = yohpwjyfgo qzhyzpasqg (xccqhyrvph )
Positive
30 May 2025
Giredestrant (G) + Atezolizumab (ATEZO) + Abemaciclib (ABEMA)
jwuzdopzco(sfhjbinesz) = bbhscejazt qzhyzpasqg (xccqhyrvph )
Not Applicable
-
Abemaciclib + Endocrine Therapy
moefpgorao(srldmmygjc) = higher adverse events were observed in the abemaciclib group wzqabfeegb (xnyiqejhwo )
Positive
30 May 2025
Endocrine Therapy Alone
Phase 2
90
Abemaciclib 50 mg BID
owryesesar(mlvoujwetp) = nhiwnenwqi ddbmgruwgh (nexvjdxyfo )
Positive
30 May 2025
Phase 3
859
Imlunestrant 400 mg QD
xweyqhcqqi(pdehxntfka) = 1/0 and 2/0 lueamhplpz (iozqufysgy )
Positive
30 May 2025
Standard therapy (fulvestrant or exemestane)
Not Applicable
Adjuvant
HR+ | HER2-
160
Abemaciclib + Endocrine Therapy
jsmfwemciw(qlsnglzvkg) = wxnnoqivdg rquxoyecvm (djidiqphwa )
Positive
30 May 2025
Early Phase 1
Carcinoma of urinary bladder, invasive
Neoadjuvant
RB1 phosphorylation | somatic mutations | CCND1 amplification
20
Abemaciclib 200mg BID PO
joyivddxyf(tbjpqgtwop) = 1/20 in Abemaciclib 200mg BID PO group xnvpcxzjgr (zyqwnwkucg )
Positive
30 May 2025
Phase 1/2
AIDS-related Kaposi Sarcoma
HIV-associated | HIV-negative
-
Abemaciclib 200mg BID
hclcnrqnbf(tmiwlbiput) = 63% nqfgenrsqq (yxjhwhrqoc )
Positive
30 May 2025
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Regulation

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