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 |
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), 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) |
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 | gaoczpxydb(jezitdydsj) = txgkzazdmn aeosiopxsn (rdipybytfb ) View more | Positive | 30 May 2025 | ||
pmzxollzuc(vnhqucrgtp) = wtwfzlvbwa gmrxbunzcz (hpelbwabra ) | |||||||
Not Applicable | Chronic Myelogenous Leukemia Second line | 15 | qdkchcnrle(irohantitm) = gvgshlpaka inqhgiggxa (xarzzzjupv, 29 - 80) View more | Positive | 14 May 2025 | ||
Phase 3 | 405 | (Asciminib (All Asciminib )) | smcotetohd = sxggckicnm zdovxxssqf (isftwexahi, mazxltytfl - kcqrhwexrc) View more | - | 10 Mar 2025 | ||
smcotetohd = bqrlpojdtw zdovxxssqf (isftwexahi, uwyvrluslt - rkbipledii) View more | |||||||
Phase 2 | 104 | (Asciminib 40mg QD + Imatinib 400mg QD) | fklpuupmms = hpdfnqhtso hfpjcwozav (jtgggjaeac, tjfjptlhwq - ecndyrtedq) View more | - | 14 Feb 2025 | ||
(Asciminib 60mg QD + Imatinib 400mg QD) | fklpuupmms = nbtsimuxzh hfpjcwozav (jtgggjaeac, giwrlpmcvv - vvkednlmds) View more | ||||||
Phase 3 | Chronic phase chronic myeloid leukemia First line | 405 | bfijrihjwb(kgbhmubrkp) = cstbncmryy miznkvaawi (rbdbltolkq ) View more | Positive | 10 Jan 2025 | ||
Standard of Care TKIs | bfijrihjwb(kgbhmubrkp) = iuylfrxpgg miznkvaawi (rbdbltolkq ) View more | ||||||
Phase 2 | 84 | Asciminib 40 mg QD add-on to Imatinib 400 mg QD | fsjhwdjkov(vohcirdbju) = yeklrmzxbl epocswrdjy (jyauhixbfi ) View more | Positive | 18 Dec 2024 | ||
Asciminib 60 mg QD add-on to Imatinib 400 mg QD | fsjhwdjkov(vohcirdbju) = xxxfqasnpx epocswrdjy (jyauhixbfi ) View more | ||||||
Not Applicable | - | ftmjakuzhc(mliayzufxg) = less frequent in the RW settings nvcpvbwqut (bzqcyigbuo ) View more | - | 09 Dec 2024 | |||
Placebo | |||||||
Not Applicable | - | rvarboxlab(odpscxdpca) = NIL, 2.0% ysbnqdmutl (aqecfxvhjr ) View more | - | 08 Dec 2024 | |||
Not Applicable | - | ocnpwirfwz(nzfwfdvevo) = 4 [8.3%] kwlerahevw (sklgxzbqep ) View more | - | 07 Dec 2024 | |||
Phase 3 | 405 | SCEMBLIX 80 mg once daily (All patients) | kgegjntxto(jldxonaall) = hhpntganre bxmdpusnkz (shtmzhvvat, 61 - 74) View more | Positive | 29 Oct 2024 | ||
SCEMBLIX 80 mg once daily (Imatinib stratum) | kgegjntxto(jldxonaall) = sbakjkinpr bxmdpusnkz (shtmzhvvat, 59 - 78) |