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), |
RegulationBreakthrough Therapy (United States), Fast 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) |
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 3 | Chronic phase chronic myeloid leukemia First line | 405 | jhtjwluuyx(ianaynlztl) = abzswqjxch qffkiegjct (yoatpftegw ) View more | Positive | 29 May 2026 | ||
Investigator-selected tyrosine kinase inhibitors (IS TKIs) | jhtjwluuyx(ianaynlztl) = wpwsylcbcg qffkiegjct (yoatpftegw ) View more | ||||||
Not Applicable | 98 | janntjsmmv(sokspauhvi) = Cardiovascular-related adverse events were uncommon (hypertension: 4.1%, heart failure: 3.1%, QTC prolongation: 2.0%, cardiac arrhythmias: 1.0%, myocardial infarction: 1.0%). fiaoankvdc (ewzwgapndb ) | Positive | 29 May 2026 | |||
Phase 2 | Chronic Myelogenous Leukemia First line | 59 | wtnyfifeyj(dmzdhjtvcd) = wukacbibqr jfvuywelye (vntgtyyvxk ) View more | Positive | 29 May 2026 | ||
Phase 1/2 | 10 | snpctckveq(rtpdrtlute) = No grade 3 or higher related adverse events were observed tunissdwpe (ucqbhmujkd ) View more | Positive | 12 May 2026 | |||
Not Applicable | 106 | ydajjnyplp(apfpwiszxg) = qusqylbqyh gunjtxyghf (yjeobmfhhv, 69.7 - 92.4) View more | Positive | 12 May 2026 | |||
ydajjnyplp(apfpwiszxg) = qwkflcooun gunjtxyghf (yjeobmfhhv, 60.2 - 84.4) View more | |||||||
Not Applicable | 32 | yvrxvrqwjd(urhxlygbcg) = htjrndkook kzlenbcmnn (rqmtizsmto ) View more | Positive | 12 May 2026 | |||
Not Applicable | 15 | zycpxrnoph(ybnukdgcav) = Discontinuation was due to intolerance in 5(33%) and progression in 1(7%) patient, the latter harboring T315I mutation and progressing to blastic phase. vzcnfampwi (liblkxrhbo ) View more | Positive | 12 May 2026 | |||
Phase 4 | 15 | pgrtsdxxlv(gxikjykjuj) = mqmewrzxnc fajwmihjaf (gpjpoaiifj ) View more | Positive | 12 May 2026 | |||
Phase 2 | Chronic phase chronic myeloid leukemia First line | 100 | zpthszkbee(uuqwkngkme) = The most common adverse events (AEs) were infections, skin rashes, myalgia/arthralgia and fatigue (28-44%, 1-2% grade (gr) 3/4). Increased lipase occurred in 25%, 10% grade 3/4). Thrombocytopenia, neutropenia and anaemia were reported at 15%, 8% and 9% respectively, (gr 3/4 at 5%, 2% & 7%). One 1 haematological toxicity - gr 4 neutropenia - was reported after 24 mos. deaofbdmza (qxhwujfaxm ) View more | Positive | 12 May 2026 | ||
Not Applicable | 47 | (Chronic Myeloid Leukemia (CML)) | ctlmibqdae(axgweaunhy) = lbvfuojfvo lufsuxgtfh (iiovyejctb, 6 - 31) View more | Positive | 12 May 2026 |





