Drug · Small Molecule

Asciminib

CI-DRUG-00000081Explore in graph →NCIt C114494 CHEMBL4208229 CIViC Approved

Regulatory

Approvals (10)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory10 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as SCEMBLIX (DIN 02528320) under ATC L01EA06 ASCIMINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 1, 2022	health-canada-dpd
CA Health Canada	—	Marketed in Canada as SCEMBLIX (DIN 02528339) under ATC L01EA06 ASCIMINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 1, 2022	health-canada-dpd
EU EMA	Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive	Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).	approved

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	16	9	6	26	10	CA, EU, US	Oct 29, 2021	Apr 24, 2014
Leukemia	Approved	Phase 3	10	6	4	18	1	EU	Aug 25, 2022	Apr 24, 2014

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (4)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–4 of 4 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ABL2 Fusion1
Asciminib + BCR-ABL Inhibitor HS-10382

Clinical trials

Trials with this intervention (27)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–27 of 27 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06236724	Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.	recruiting	Phase 2	150	M.D. Anderson Cancer CenterOTHER	1	Sep 25, 2026	clinicaltrials
NCT06308588	Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase ABL inhibitor; Bcr/Abl fusion protein inhibitor
Targets: 2 genes
UNII: C5U34S9XFV
Aliases: ABL 001, ABL-001, ABL001, ABL-0013-PYRIDINECARBOXAMIDE, ABL001-NX, Asciminib, ASCIMINIB (ABL001), Asciminib Hydrochloride, AY7, N-[4-(CHLORODIFLUOROMETHOXY)PHENYL]-6-[(3R)-3-HYDROXY-1-PYRROLIDINYL]-5-(1H-PYRAZOL-3-YL)-, NVP-ABL001, SCEMBLIX

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (6)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EA06	ASCIMINIB
DIN (Health Canada)	02528320	SCEMBLIX

ABL1 Fusion2
Asciminib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	A	Supports Sensitivity Response	4	submitted	EID11223 233 patients aged 18 or older who had Ph+ CML and were previously treated with two or more tyrosine kinase inhibitors were recruited to an open-label, multicentre phase 3 trial. The patients were rand… (full text at CIViC) PMID 34407542 · Réa et al., 2021 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	A	Supports Sensitivity Response	4	submitted	EID12213 In the phase 3 ASC4FIRST trial (NCT04971226), patients with newly diagnosed Ph+ CML were randomized 1:1 to receive either asciminib (n=201) or an investigator-selected TKI (n=204). At week 48, major m… (full text at CIViC) PMID 38820078 · Hochhaus et al., 2024 · Open in CIViC	civic