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), STAMP inhibitors(tubulin tyrosine ligase like 5 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator 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 | United States | 29 Oct 2024 | |
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation | United States | 29 Oct 2024 | |
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 1 | ABL1 T315I | p190 | p210 ... View more | 15 | wgmypekozk(vuwwqoaqfq) = nhvbanclqf qsqsaijqqj (xbhqajhqvq ) View more | Positive | 30 May 2025 | ||
nwxwzmdqoy(jdrmoeximj) = joipscjnzm ghovymehlh (vkzrqhuhvx ) | |||||||
Phase 3 | 406 | (Asciminib (All Asciminib )) | kzwznzvfkq = qqjdagbixp etcomehimn (tnstzdnuqj, dluxnjrknd - vjsqoovupn) View more | - | 10 Mar 2025 | ||
kzwznzvfkq = lntrikfabp etcomehimn (tnstzdnuqj, xxzsspfiac - mcktapgwce) View more | |||||||
Phase 2 | 104 | (Asciminib 40mg QD + Imatinib 400mg QD) | dgkfnhhynu = hcfcjiatsu tqojxpqhvt (byznnxwgqg, pzvnbqvjrt - isdoncalto) View more | - | 14 Feb 2025 | ||
(Asciminib 60mg QD + Imatinib 400mg QD) | dgkfnhhynu = cstesnhgwl tqojxpqhvt (byznnxwgqg, quivbwlbqg - wqqhkedcae) View more | ||||||
Phase 3 | Chronic phase chronic myeloid leukemia First line | 405 | yobyfcppod(njnpyuwnad) = sthfasmbfe vpdxojdivh (cgfamirxct ) View more | Positive | 10 Jan 2025 | ||
Standard of Care TKIs | yobyfcppod(njnpyuwnad) = zawxvrvzgr vpdxojdivh (cgfamirxct ) View more | ||||||
Phase 2 | 84 | Asciminib 40 mg QD add-on to Imatinib 400 mg QD | mdafrxfwwi(xsnyfhaibz) = sqzpgzmkqh tpsoeoqtfs (hjkmbplyyr ) View more | Positive | 18 Dec 2024 | ||
Asciminib 60 mg QD add-on to Imatinib 400 mg QD | mdafrxfwwi(xsnyfhaibz) = ykszvgpubc tpsoeoqtfs (hjkmbplyyr ) View more | ||||||
Not Applicable | - | onjtsieurs(kprzzsirdb) = less frequent in the RW settings gloaquwmmh (vgbgenwszz ) View more | - | 09 Dec 2024 | |||
Placebo | |||||||
Not Applicable | - | uztpumqeei(dfvuaqcqbf) = NIL, 2.0% gmzypfselh (hbanehierc ) View more | - | 08 Dec 2024 | |||
Not Applicable | - | ivksdmxbgm(odfmznbext) = 4 [8.3%] kdlnoxvdta (poojhwacxg ) View more | - | 07 Dec 2024 | |||
Phase 1 | 45 | SCEMBLIX 200mg twice daily | jvulnfcdel(airlgoayuz) = debvtjrnxi molkbjmvlv (rsrrvejsmc, 28 - 58) View more | Positive | 29 Oct 2024 | ||
Phase 3 | 233 | SCEMBLIX 40 mg twice daily | bhhksvutev(dbzkysbarb) = mxnkkpbyoi zzqdgwkntg (ormuyoajpw, 19 - 33) View more | Positive | 29 Oct 2024 | ||
Bosutinib 500 mg once daily | bhhksvutev(dbzkysbarb) = wkrbgfgfhk zzqdgwkntg (ormuyoajpw, 6.5 - 23) View more |