Drug Type Small molecule drug |
Synonyms Abemaciclib (JAN/USAN), Abemaciclib mesylate, Bemaciclib + [8] |
Target |
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 |
Drug Highest PhaseApproved |
First Approval Date US (28 Sep 2017), |
RegulationBreakthrough Therapy (US), Fast Track (US), Priority Review (CN), Special Review Project (CN) |
Molecular FormulaC27H32F2N8 |
InChIKeyUZWDCWONPYILKI-UHFFFAOYSA-N |
CAS Registry1231929-97-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10688 | Abemaciclib |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Castration-sensitive prostate cancer | Phase 3 | US | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | CN | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | JP | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | AR | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | AU | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | BE | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | BR | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | CA | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | CZ | 14 Apr 2022 | |
Castration-sensitive prostate cancer | Phase 3 | FR | 14 Apr 2022 |
Phase 2 | 4 | (Fulvestrant) | dbauitifly(cqmeccpdgq) = oaadddqjod kbjyewyktx (dzatqwuaxx, ysjkxoosbo - thlpdglqnu) View more | - | 27 Dec 2024 | ||
palbociclib (Ibrance)+fulvestrant (Continuing AI After Randomization) | dbauitifly(cqmeccpdgq) = wyxyssshfx kbjyewyktx (dzatqwuaxx, navfvxhwti - pofbniawis) View more | ||||||
Phase 3 | 874 | nrbhsmnxep(rqfhyzwwql) = uvducasgrx blhptgssyy (xzsveomliw ) View more | Positive | 11 Dec 2024 | |||
Standard therapy | nrbhsmnxep(rqfhyzwwql) = iugkdgsodj blhptgssyy (xzsveomliw ) View more | ||||||
Phase 1/2 | ER-positive/HER2-negative Breast Cancer HER2 Negative | 55 | (all efficacy-evaluable) | nviraaowcc(xcfmnnmxiy) = lbvbqugpyr dnjycbzlet (xclpdaudrd ) | Positive | 10 Dec 2024 | |
(ESR1-mut population) | nviraaowcc(xcfmnnmxiy) = twhmidtbxm dnjycbzlet (xclpdaudrd ) | ||||||
Phase 1 | ER-positive/HER2-negative Breast Cancer Third line | 16 | kaaxvaleer(mcmgwbdlfw) = None owvuniirdd (eopoxwdaiz ) View more | Positive | 10 Dec 2024 | ||
(mutant ESR1) | |||||||
Phase 2 | NF2 mutations | CDK pathway alterations | 36 | Abemaciclib 200 mg | mkfqyqggqs(okwiqabaef) = wpztpqsnbl ljgyxapmjn (xldjvbcvaj, 33 - 75) View more | Positive | 11 Nov 2024 | |
Early Phase 1 | Recurrent Glioblastoma intact RB | pERK expression | 42 | wasqycxpur(pbuyqoeqck) = rwhiskywon taearysuyw (hmaiwgljnb ) View more | Negative | 11 Nov 2024 | ||
Phase 3 | Hormone receptor positive HER2 negative breast cancer Second line | First line Hormone Receptor Positive | HER2 Negative | - | xgvzwctfey(fiacctrrrs) = exxflgzoim rslbwzjmmh (ginjtmzzai ) | Positive | 10 Oct 2024 | ||
xgvzwctfey(fiacctrrrs) = eqjscoivnq rslbwzjmmh (ginjtmzzai ) | |||||||
Phase 2 | 4 | hnxeeqeiei(njpeltjmqo) = pjzesmwzvs tnppmgnoeg (mhymvoazgt, tztecwsqzm - wkffnbnubq) View more | - | 08 Oct 2024 | |||
Not Applicable | Breast Cancer Adjuvant | 10 | Concurrent abemaciclib and postoperative radiotherapy | cwgbddrfrq(huzqhofplx) = leukopenia admgopafmx (cwfkqdcrmb ) View more | Positive | 01 Oct 2024 | |
Phase 2 | 9 | zwxucxgbru(ljnmcjggqj) = cjjuwlbowd qchudbtort (qvoypdmfal, fhjqyzeqqy - netqnrcyzu) View more | - | 19 Sep 2024 |