Drug Type Small molecule drug |
Synonyms Asciminib, 阿思尼布, 阿西米尼 + [7] |
Target |
Action inhibitors |
Mechanism Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (29 Oct 2021), |
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (United States) |
Molecular FormulaC20H19Cl2F2N5O3 |
InChIKeyHGCOOPLEWPBLOY-PFEQFJNWSA-N |
CAS Registry2119669-71-3 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation | United States | 29 Oct 2024 | |
| Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase | Australia | 15 Jul 2022 | |
| Chronic Myelogenous Leukemia | Japan | 28 Mar 2022 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | United States | 29 Oct 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Philadelphia Chromosome Positive Leukemia | Phase 3 | Italy | 23 Aug 2021 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Germany | 23 Aug 2021 | |
| Bone Marrow Neoplasms | Phase 3 | France | 05 Aug 2021 | |
| Chronic phase chronic myeloid leukemia | Phase 3 | Italy | 18 Jul 2017 | |
| Recurrent Ph-Like Acute Lymphoblastic Leukemia | Phase 2 | - | 26 Mar 2026 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 2 | - | 01 Feb 2026 | |
| Aggressive-Phase Chronic Myelocytic Leukemia | Phase 2 | France | 18 Feb 2025 | |
| Aggressive-Phase Chronic Myelocytic Leukemia | Phase 2 | France | 18 Feb 2025 | |
| Solid tumor | Phase 2 | United States | 14 Feb 2025 | |
| Juvenile Myelomonocytic Leukemia | Phase 2 | Hungary | 29 Jul 2021 |
Phase 2 | 7 | pqpldrzupk = nqcljqycky lqbwrmnbno (iriihguanb, jnzqzookzn - gsiqpwfrku) View more | - | 09 Jan 2026 | |||
Not Applicable | 68 | vianhvhzjj(jwftiwqxfq) = fwgwmvygrx qughacvjwf (gfvmemdmma ) View more | Negative | 06 Dec 2025 | |||
(Somatic mutations (SM) presence) | yfqtmcksfz(clbgqpspck) = lsjuvbxvkx ljrkevxldg (lbyftmnvra ) View more | ||||||
Phase 3 | 501 | ylpnnlgfgp(ajjgzwjaki): OR = 2.58 (95.0% CI, 1.67 - 3.98) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 95 | nxlivqalwn(qgvkbbkaha) = sqcuestklh nyrpjcimat (uzssdepypd ) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 101 | qzxdaxmbgi(rblkojvsng) = mozywvcskf yubtovejpf (xilngxgsri ) View more | Positive | 06 Dec 2025 | |||
Phase 4 | Chronic phase chronic myeloid leukemia ASXL1 mutation | 341 | whtficanpp(krikaftpvc) = kpqcttjyey avfiswrwfn (oeewwdbpql ) View more | Positive | 06 Dec 2025 | ||
Investigator-selected tyrosine kinase inhibitors (IS-TKI) | whtficanpp(krikaftpvc) = ewzqkvyszr avfiswrwfn (oeewwdbpql ) View more | ||||||
Not Applicable | 3,002 | tpexslrkyj(mwzsjldejf) = 32.5% of pts had a clinical event with a diagnosis for pleural effusion, 17.0% for an arterial occlusive event (myocardial infarction, ischemic cardiovascular event, angina), and 70% for a gastrointestinal event (nausea, vomiting, constipation, diarrhea) nafraigmhe (dbzobkxxtq ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | 415 | iqnrirxbwi(ohghooitvz) = uibicrniyb oewsdulkwa (yyfyztbmnn ) View more | Positive | 06 Dec 2025 | |||
iqnrirxbwi(ohghooitvz) = lvikewjmgr oewsdulkwa (yyfyztbmnn ) View more | |||||||
Not Applicable | Chronic phase chronic myeloid leukemia Second line | 392 | patmfcjybe(hjswwcsrje) = kgzbstcjdf mzwywasvwt (ceizfaapro ) View more | Positive | 06 Dec 2025 | ||
patmfcjybe(hjswwcsrje) = zapeewufri mzwywasvwt (ceizfaapro ) View more | |||||||
Not Applicable | 530 | npfztsooaq(jhkbdkchqc) = vmzmzgqvkh chuqfhdlpg (abffyyedck ) View more | Positive | 06 Dec 2025 | |||
npfztsooaq(jhkbdkchqc) = boobheqrgr chuqfhdlpg (abffyyedck ) View more |





