Asciminib

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Asciminib is an onp drug catalogued in DrugCentral. It was first approved by the EMA in 2020. DrugCentral lists 2 molecular targets, including ABL1 and KCNH2. Recorded indications include Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

• Approval status: onp (first approved 2020 by the EMA).
• Molecular targets: ABL1 and KCNH2 (2 listed in DrugCentral).
• Indications: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
• ATC code: L01EA06 (BCR-ABL tyrosine kinase inhibitors).
• Molecular formula: C20H18ClF2N5O3; molecular weight 449.85 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)

Mechanism & targets

Molecular targets (2)

Target	Gene	Action	Activity
Tyrosine-protein kinase ABL1	ABL1	inhibitor	IC50 8.59
Potassium voltage-gated channel subfamily H member 2	KCNH2	unknown	IC50 4.58

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2022-03-28	PMDA	—	Novartis Pharma K.K.	Yes
2021-10-29	FDA	—	NOVARTIS	Yes
2020-03-24	EMA	—	Novartis Europharm Limited	Yes

ATC classification

ATC code	Therapeutic hierarchy
L01EA06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › PROTEIN KINASE INHIBITORS › BCR-ABL tyrosine kinase inhibitors

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

• EMA label: ABL1, BCR · Testing Required
• FDA label: ABL1, BCR · Testing Required
• HCSC label: ABL1, BCR · Testing Required

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Philadelphia chromosome positive	252.3
Cytopenia	219.6
Thrombocytopenia	187.3
Cytogenetic analysis abnormal	163.3
Lipase increased	150.5
Pleural effusion	126.3
Blast crisis in myelogenous leukaemia	114.5
Pericardial effusion	100.8
Malignant neoplasm progression	87.4
Drug intolerance	84.1
Drug resistance	75.9
Pancreatitis	73.1

Chemical structure

• Molecular formula: C₂₀H₁₈ClF₂N₅O₃
• Molecular weight: 449.85 g/mol
• CAS number: —
• InChIKey: VOVZXURTCKPRDQ-CQSZACIVSA-N
• PubChem CID: 72165228

O=C(Nc1ccc(OC(F)(F)Cl)cc1)c1cnc(N2CC[C@@H](O)C2)c(-c2cc[nH]n2)c1

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Asciminib used for?

DrugCentral lists the following indications for Asciminib: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

How does Asciminib work?

Its molecular targets in DrugCentral include ABL1 (inhibitor) and KCNH2.

When was Asciminib first approved?

Asciminib was first approved by the EMA in 2020.

What is the chemical formula of Asciminib?

Asciminib has the molecular formula C20H18ClF2N5O3 and a molecular weight of 449.85 g/mol.

Sources

• DrugCentral drug card 5495 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4208229 — compound record and bioactivity
• PubChem CID 72165228 — chemical identifiers
• DrugBank DB12597 — drug record
• FDA UNII L1F3R18W77 — substance identity
• DailyMed: FDA labels for Asciminib — current prescribing information (label search)
• UniProt P00519 (ABL1) — target protein
• UniProt Q12809 (KCNH2) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
• PharmGKB / CPIC — pharmacogenomic label annotations

How this page is built: methodology · editorial policy & corrections.