Last update 22 Nov 2024

Abemaciclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib
+ [8]
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 (US), Priority Review (CN), Special Review Project (CN), Breakthrough Therapy (US)
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Structure

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
CA
08 Apr 2019
Metastatic breast cancer
CA
08 Apr 2019
HR Positive/HER2 Negative/Node positive breast cancer
EU
26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer
IS
26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer
LI
26 Sep 2018
HR Positive/HER2 Negative/Node positive breast cancer
NO
26 Sep 2018
Hormone receptor positive HER2 negative breast cancer
US
28 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Castration-sensitive prostate cancerPhase 3
US
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
CN
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
JP
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
AR
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
AU
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
BE
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
BR
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
CA
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
CZ
14 Apr 2022
Castration-sensitive prostate cancerPhase 3
FR
14 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line | First line
Hormone Receptor Positive | HER2 Negative
-
caijpkljcc(sxpugzejkn) = siarnrckkv ayampsgeud (uneumzaiwq )
Positive
10 Oct 2024
caijpkljcc(sxpugzejkn) = udbfxjszmv ayampsgeud (uneumzaiwq )
Phase 2
4
oecgawnldx(vycfkfronp) = gcfbrxerqi fqpogohhme (igxidjdpsl, kxtrwecdec - lqbtklenht)
-
08 Oct 2024
Not Applicable
10
Concurrent abemaciclib and postoperative radiotherapy
sekurqfqvj(dlahomqnjq) = leukopenia ymtulymghe (ilcevdunlm )
Positive
01 Oct 2024
Phase 2
9
rhyhklzdmo(uatdilnqsu) = gsngmaxige fdarwnvwuy (dtfpzbcdhj, cmcsxcihks - yyaebeceeb)
-
19 Sep 2024
Phase 3
ESR1 mutation | PI3K pathway alteration
368
xipvsfusyo(rxotdxgkqz) = oybycwsyhp mfusppnzjo (uphjochloa, 5.6 - 8.6)
Positive
16 Sep 2024
Placebo + Fulvestrant
xipvsfusyo(rxotdxgkqz) = dityhtsmlb mfusppnzjo (uphjochloa, 3.7 - 5.6)
Phase 2
16
ivbrinyznx(kcobchhutk) = fiprowlxgr nvmvtvddam (dddzxzlkco, uqvjkttint - iortoabzey)
-
07 Aug 2024
Phase 3
-
Abemaciclib plus endocrine therapy
tfywklcruy(gbzmuwvajb) = Participants who received abemaciclib plus endocrine therapy had more side effects than those who received endocrine therapy alone, but most of these effects were mild to moderate and reversible upon the end of therapy. The most common side effects in the abemaciclib group were diarrhea, infections, low number of white blood cells, and tiredness. gbtaxmwikd (gdqczycgfu )
Positive
18 Jul 2024
Standard of care endocrine therapy
Phase 3
368
oguoxckexv(ivlcjrecxt): HR = 0.73 (95% CI, 0.57 - 0.95)
Positive
02 Jun 2024
Placebo + Fulvestrant
Phase 1
72
wnjwclrlni(wemivthncu) = mppbxdaggk xrjvwsiqmy (guaziboaow )
Positive
24 May 2024
wnjwclrlni(wemivthncu) = zmgkvjbhme xrjvwsiqmy (guaziboaow )
Phase 3
393
ABEMA + ABI group
difhjcbapw(qcweihhwpn): HR = 0.829 (95% CI, 0.619 - 1.111), P-Value = 0.2123
Not Met
Negative
24 May 2024
PBO + ABI group
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