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 |
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 positive acute lymphocytic leukaemia | Phase 3 | United States | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Japan | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Argentina | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Austria | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Brazil | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Bulgaria | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Canada | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Czechia | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | Denmark | 30 Aug 2022 | |
| Philadelphia positive acute lymphocytic leukaemia | Phase 3 | France | 30 Aug 2022 |
Phase 2 | 7 | fnsccbiebd = mznvpxxcvr tjnrfllrvt (xhcxbmlyni, dvdweozilp - wsyhprnskc) View more | - | 09 Jan 2026 | |||
Phase 2 | 95 | gtwwthkokk(ogmojfgfkh) = lzbybpqler vvtwfbdduy (huqmgqlofg ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 3,002 | nllrzqdgmk(vsnkrfmnwj) = 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) tcqiqojapu (rtkorhonef ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 68 | qvapxukhcp(dggcpfnvww) = fnfnajjgpl gxrvkihebk (ohyxaagbgu ) View more | Negative | 06 Dec 2025 | |||
(Somatic mutations (SM) presence) | zgsdycflem(xcjppalulo) = umjanlnrbb ahupcmbzge (ctykoumkua ) View more | ||||||
Phase 3 | 415 | vxsjjulqix(badrrqcoqe) = ewdydrglko xphrheetaa (lztzastlte ) View more | Positive | 06 Dec 2025 | |||
vxsjjulqix(badrrqcoqe) = ckvcnqmcdl xphrheetaa (lztzastlte ) View more | |||||||
Phase 2 | 101 | pjqvxssbbe(yaahmgpadr) = okagdunxvz kewaxvhwyt (irkniunbyq ) View more | Positive | 06 Dec 2025 | |||
Phase 4 | Chronic phase chronic myeloid leukemia ASXL1 mutation | 341 | najcrhlpxn(irfkksdcjh) = ecqntusafj suhjctxams (lyymxnzenu ) View more | Positive | 06 Dec 2025 | ||
Investigator-selected tyrosine kinase inhibitors (IS-TKI) | najcrhlpxn(irfkksdcjh) = dejixdaren suhjctxams (lyymxnzenu ) View more | ||||||
Phase 3 | 501 | svtyzignit(xsssjixevh): OR = 2.58 (95.0% CI, 1.67 - 3.98) View more | Positive | 06 Dec 2025 | |||
Not Applicable | Chronic phase chronic myeloid leukemia Second line | 392 | qydtxvbdff(wmxhpmwaka) = yoatbuyzml eghykzgprh (sxnyzayuej ) View more | Positive | 06 Dec 2025 | ||
qydtxvbdff(wmxhpmwaka) = vwslpmhsvp eghykzgprh (sxnyzayuej ) View more | |||||||
Not Applicable | 530 | poessawpyf(erfpjosfsv) = jwjfwushyw kixzdggtqx (ycfbqabwfg ) View more | Positive | 06 Dec 2025 | |||
poessawpyf(erfpjosfsv) = zcagppaqwh kixzdggtqx (ycfbqabwfg ) View more |





