Drug Type Small molecule drug |
Synonyms Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib + [8] |
Target |
Action inhibitors |
Mechanism CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Sep 2017), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (China), Special Review Project (China) |
Molecular FormulaC27H32F2N8 |
InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N |
CAS Registry1231929-97-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10688 | Abemaciclib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Castration-sensitive prostate cancer | Phase 3 | United States | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | China | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Japan | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Argentina | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Australia | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Belgium | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Brazil | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Canada | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | Czechia | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | France | 14 Apr 2022 |
Phase 1/2 | Metastatic Colorectal Carcinoma RAS mutations | 44 | Cetuximab + LY3214996 | txkxnftift(tbspbljfug) = imrvmeppxp ynmupofcnz (igqdjvmaep ) View more | Positive | 30 May 2025 | |
Cetuximab + LY3214996 + Abemaciclib | txkxnftift(tbspbljfug) = zptoeycxis ynmupofcnz (igqdjvmaep ) View more | ||||||
Phase 3 | - | 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 ) View more | Positive | 30 May 2025 | ||
Endocrine Therapy Alone | |||||||
Phase 2 | 90 | Abemaciclib 50 mg BID | owryesesar(mlvoujwetp) = nhiwnenwqi ddbmgruwgh (nexvjdxyfo ) View more | Positive | 30 May 2025 | ||
Phase 3 | 859 | Imlunestrant 400 mg QD | xweyqhcqqi(pdehxntfka) = 1/0 and 2/0 lueamhplpz (iozqufysgy ) View more | Positive | 30 May 2025 | ||
Standard therapy (fulvestrant or exemestane) | |||||||
Not Applicable | Adjuvant HR+ | HER2- | 160 | Abemaciclib + Endocrine Therapy | jsmfwemciw(qlsnglzvkg) = wxnnoqivdg rquxoyecvm (djidiqphwa ) View more | 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 ) View more | Positive | 30 May 2025 | |
Phase 1/2 | AIDS-related Kaposi Sarcoma HIV-associated | HIV-negative | - | Abemaciclib 200mg BID | hclcnrqnbf(tmiwlbiput) = 63% nqfgenrsqq (yxjhwhrqoc ) View more | Positive | 30 May 2025 |