Ensartinib

Drug profile

Key facts

Ensartinib is an onp drug catalogued in DrugCentral. It was first approved by the FDA in 2024. DrugCentral lists 3 molecular targets, including ALK, MET and ROS1. Recorded indications include Anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.

• Approval status: onp (first approved 2024 by the FDA).
• Molecular targets: ALK, MET and ROS1 (3 listed in DrugCentral).
• Indications: Anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.
• Molecular formula: C26H27Cl2FN6O3; molecular weight 561.44 g/mol.

Indications & contraindications

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

Indications (1)

• Anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer

Mechanism & targets

Molecular targets (3)

Target	Gene	Action	Activity
ALK tyrosine kinase receptor	ALK	inhibitor	IC50 9.60
Hepatocyte growth factor receptor	MET	inhibitor	IC50 9.13
Proto-oncogene tyrosine-protein kinase ROS	ROS1	inhibitor	IC50 8.00

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
2024-12-18	FDA	—	: Xcovery Holdings, Inc.

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

• FDA label: ALK · Testing Required

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Ensartinib is on its molecule page.

• Molecular formula: C₂₆H₂₇Cl₂FN₆O₃
• Molecular weight: 561.44 g/mol
• CAS number: 1370651-20-9
• InChIKey: GLYMPHUVMRFTFV-QLFBSQMISA-N
• PubChem CID: 56960363

C[C@@H]1CN(C[C@@H](N1)C)C(=O)C2=CC=C(C=C2)NC(=O)C3=NN=C(C(=C3)O[C@H](C)C4=C(C=CC(=C4Cl)F)Cl)N

Frequently asked questions

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

What is Ensartinib used for?

DrugCentral lists the following indications for Ensartinib: Anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.

How does Ensartinib work?

Its molecular targets in DrugCentral include ALK (inhibitor), MET (inhibitor) and ROS1 (inhibitor).

When was Ensartinib first approved?

Ensartinib was first approved by the FDA in 2024.

What is the chemical formula of Ensartinib?

Ensartinib has the molecular formula C26H27Cl2FN6O3 and a molecular weight of 561.44 g/mol.

Sources

• DrugCentral drug card 5845 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4113131 — compound record and bioactivity
• PubChem CID 56960363 — chemical identifiers
• DrugBank DB13104 — drug record
• FDA UNII SMA5ZS5B22 — substance identity
• DailyMed: FDA labels for Ensartinib — current prescribing information (label search)
• UniProt Q9UM73 (ALK) — target protein
• UniProt P08581 (MET) — target protein
• UniProt P08922 (ROS1) — target protein
• PharmGKB / CPIC — pharmacogenomic label annotations

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