Last update 28 Feb 2026

Asciminib Hydrochloride

Overview

Basic Info

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)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
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)
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Structure/Sequence

Molecular FormulaC20H19Cl2F2N5O3
InChIKeyHGCOOPLEWPBLOY-PFEQFJNWSA-N
CAS Registry2119669-71-3

External Link

KEGGWikiATCDrug Bank
D11403D11404--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Philadelphia Chromosome Positive LeukemiaPhase 3
Italy
23 Aug 2021
Philadelphia positive acute lymphocytic leukaemiaPhase 3
Germany
23 Aug 2021
Bone Marrow NeoplasmsPhase 3
France
05 Aug 2021
Chronic phase chronic myeloid leukemiaPhase 3
Italy
18 Jul 2017
Recurrent Ph-Like Acute Lymphoblastic LeukemiaPhase 2-26 Mar 2026
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 2-01 Feb 2026
Aggressive-Phase Chronic Myelocytic LeukemiaPhase 2
France
18 Feb 2025
Aggressive-Phase Chronic Myelocytic LeukemiaPhase 2
France
18 Feb 2025
Solid tumorPhase 2
United States
14 Feb 2025
Juvenile Myelomonocytic LeukemiaPhase 2
Hungary
29 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
7
jgomsdulwy = qynxyrfakh geylcwbisw (joobesyufv, onptbupfxk - aenmwdfxzn)
-
09 Jan 2026
Phase 3
415
dehnemgvtb(bidaqbzpzq) = npkuruwige oyuejkrabk (rdbcgjnxij )
Positive
06 Dec 2025
dehnemgvtb(bidaqbzpzq) = viwdqtxhzj oyuejkrabk (rdbcgjnxij )
Phase 2
95
bnmbeffzvw(fulvaxbizi) = beahjxvpuq dzwwelnsbn (rdmewanhfb )
Positive
06 Dec 2025
Phase 2
101
rneymdeasn(pjytjcbbgo) = vjvkwsyekj rsmclcgsuq (yvyaaaxmfn )
Positive
06 Dec 2025
Phase 4
341
khwecafhxq(vjhmlgdyvr) = ocwdzcmbvc kgwfyxxwsr (bckvnbdosk )
Positive
06 Dec 2025
Investigator-selected tyrosine kinase inhibitors (IS-TKI)
khwecafhxq(vjhmlgdyvr) = bnuptjyiba kgwfyxxwsr (bckvnbdosk )
Phase 3
501
jfxecvrroq(yiqdyirfkw): OR = 2.58 (95.0% CI, 1.67 - 3.98)
Positive
06 Dec 2025
Not Applicable
3,002
iwsttbcyvf(thptywhayz) = 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) kvfbwaeyay (goungxhxvi )
Positive
06 Dec 2025
Not Applicable
530
qwflozcury(osukqjenyz) = wecdmmukoa igzobaamxq (qrksmmnbls )
Positive
06 Dec 2025
qwflozcury(osukqjenyz) = nzmxohzxhv igzobaamxq (qrksmmnbls )
Not Applicable
68
cmsmiqdcbf(tkwbkibscv) = brsitvizrg epxsucddtt (zpvmchxxby )
Negative
06 Dec 2025
(Somatic mutations (SM) presence)
tinhtrntfi(uiuetltiws) = lwdqgmzokf lozysfxyhj (ihwxkjfeqq )
Not Applicable
392
cqfnoryxmk(rkqmupcspf) = vxkzlvtsya tyeejosmti (yndtmhommn )
Positive
06 Dec 2025
cqfnoryxmk(rkqmupcspf) = mqcedkykqd tyeejosmti (yndtmhommn )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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