Last update 15 Jul 2024

Abemaciclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib
+ [7]
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
RegulationBreakthrough Therapy (US), Fast Track (US), Priority Review (CN), Special Review Project (CN)
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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
HR Positive/HER2 Negative/Node positive breast cancer
US
12 Oct 2021
Advanced breast cancer
EU
26 Sep 2018
Advanced breast cancer
IS
26 Sep 2018
Advanced breast cancer
LI
26 Sep 2018
Advanced breast cancer
NO
26 Sep 2018
Early Stage Breast Carcinoma
EU
26 Sep 2018
Early Stage Breast Carcinoma
IS
26 Sep 2018
Early Stage Breast Carcinoma
LI
26 Sep 2018
Early Stage Breast Carcinoma
NO
26 Sep 2018
Metastatic breast cancer
EU
26 Sep 2018
Metastatic breast cancer
IS
26 Sep 2018
Metastatic breast cancer
LI
26 Sep 2018
Metastatic 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-Resistant Prostatic CancerPhase 3
US
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
CN
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
JP
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
AR
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
AU
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
BE
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
BR
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
CA
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
CZ
14 Apr 2022
Castration-Resistant Prostatic CancerPhase 3
FR
14 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
368
fbhucomuma(drdkjmeunk): HR = 0.73 (95% CI, 0.57 - 0.95)
Positive
02 Jun 2024
Placebo + Fulvestrant
Phase 1/2
ER-positive/HER2-negative Breast Cancer
Second line
HER2 Negative | ER Positive | ESR1 Mutation
26
qgvvgrisem(cmhaqrykit) = ilvcybybgz hyfnpveptu (oewgmpciby )
Positive
24 May 2024
Phase 1
72
dixawbzyuz(iimyhnfetn) = rqyjgvciok dvedhocoit (icqihlvixl )
Positive
24 May 2024
dixawbzyuz(iimyhnfetn) = mrhwxjfzhg dvedhocoit (icqihlvixl )
Phase 3
393
ABEMA + ABI group
galsyxyphz(iounnsvuci): HR = 0.829 (95% CI, 0.619 - 1.111), P-Value = 0.2123
Not Met
Negative
24 May 2024
PBO + ABI group
Phase 2
NF2mutations | CDK pathway alterations
36
Abemaciclib 200 mg
chqzojqcyl(djdlctuguq) = dmcdwjvcnb vugwrjryvt (idgervljvo, 33 - 75)
Positive
24 May 2024
Phase 2
Endometrial Carcinoma
CTNNB1 | KRAS | CDKN2Amutation ...
28
Letrozole/abemaciclib
tebbqefjmf(frkzwxxlkc) = ktvrwlzfrr uvkknztcks (lkjwuezill )
Positive
24 May 2024
Early Phase 1
Endometrial Endometrioid Adenocarcinoma
estrogen receptor | PTEN | PI3K ...
27
jzjgxxhgdj(dhuarizfxq) = tegepudwjq ryfoahjvwt (nameeeyblq, 16)
Positive
24 May 2024
Letrozole 2.5mg
jzjgxxhgdj(dhuarizfxq) = fzsqcbevmf ryfoahjvwt (nameeeyblq, 22)
Not Applicable
Hormone receptor positive HER2 negative breast cancer
First line
Hormone Receptor-positive | Human Epidermal growth factor Receptor 2-negative
1,850
ahnzwjcmaw(tfohgudskj) = tdzjhkagam qfwmyyorsq (hpdykrpuks, 32.0 - 37.4)
Positive
24 May 2024
-
Phase 2
HER2-negative breast cancer
Neoadjuvant
Ki67 | Recurrence Score (RS)
-
Letrozole/abemaciclib
weoavpvpnm(xuvihtptzk) = xigopczjuf toxurydhnc (krdeyrmgsv )
Negative
24 May 2024
Chemotherapy
weoavpvpnm(xuvihtptzk) = cxlpfzboak toxurydhnc (krdeyrmgsv )
Not Applicable
281
palbociclib+abemaciclib+proton pump inhibitors
jsmhhvejde(toyuctfwcz) = rzigxoqtln knlohamrsj (obuslfsrgd )
Positive
16 May 2024
jsmhhvejde(toyuctfwcz) = vswrbdykws knlohamrsj (obuslfsrgd )
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