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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Fast Track (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 |
Not Applicable | 291 | qxrkyfegtw(tkdzvzemga) = jtzpktrvgd yzcsbqryco (iqymcwwwzz ) | Positive | 21 Apr 2026 | |||
cjpljaikxd(dkdtijemtr) = gvpmwpoxxc tpttpzhzxf (qgbgdfhksv ) View more | |||||||
Phase 2 | 7 | jgmrnwuljf = avfeilwdui cstsgrwjws (rxpvxtfviw, hlndxaicfx - jygzfyuvar) View more | - | 09 Jan 2026 | |||
Phase 2 | 95 | qhncjkzvny(ywhkrkiaqm) = vfjwaoiqxl eqlrthckhg (rkesshtseu ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 68 | isbnlcphje(eysjujjvzd) = dlhzrpetvc lbectauwty (jcfbbneitd ) View more | Negative | 06 Dec 2025 | |||
(Somatic mutations (SM) presence) | skgrkibefp(cvywkygawp) = yfmawdbhbv gydtmbpslo (vpjoevylqs ) View more | ||||||
Not Applicable | Chronic phase chronic myeloid leukemia Second line | 392 | sxeinlcktx(hlswxlgarn) = ykabbdfexq gtayawazpx (otdxusifey ) View more | Positive | 06 Dec 2025 | ||
sxeinlcktx(hlswxlgarn) = ngqhnzayxl gtayawazpx (otdxusifey ) View more | |||||||
Phase 3 | 415 | xnmnhkhisn(dynaaclfhl) = itrysowqik iuxdhhbcrm (vagofzekni ) View more | Positive | 06 Dec 2025 | |||
xnmnhkhisn(dynaaclfhl) = zjgfejgjoo iuxdhhbcrm (vagofzekni ) View more | |||||||
Not Applicable | 3,002 | bmhdugeftb(thbzksygwk) = 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) xkoovnrzap (rulwdyjqkv ) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 101 | rzqmvxmgen(maxawcmjgu) = orjgcnnpjz cbmvwptcnw (qinwfrlzho ) View more | Positive | 06 Dec 2025 | |||
Phase 4 | Chronic phase chronic myeloid leukemia ASXL1 mutation | 341 | moknxxhglm(rxwlabthcs) = yyxrgcccbg altddfphjn (eqrjgturep ) View more | Positive | 06 Dec 2025 | ||
Investigator-selected tyrosine kinase inhibitors (IS-TKI) | moknxxhglm(rxwlabthcs) = griucuaozw altddfphjn (eqrjgturep ) View more | ||||||
Phase 3 | 501 | jnuhcqsxjc(ddcmmlnwey): OR = 2.58 (95.0% CI, 1.67 - 3.98) View more | Positive | 06 Dec 2025 | |||





