Sevabertinib

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Sevabertinib is an onp drug catalogued in DrugCentral. It was first approved by the FDA in 2025. DrugCentral lists 2 molecular targets, including EGFR and ERBB2. Recorded indications include Non-squamous non-small cell lung cancer (NSCLC).

• Approval status: onp (first approved 2025 by the FDA).
• Molecular targets: EGFR and ERBB2 (2 listed in DrugCentral).
• Indications: Non-squamous non-small cell lung cancer (NSCLC).
• ATC code: L01EH06 (Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors).
• Molecular formula: C24H25ClN4O5; molecular weight 484.94 g/mol.

Indications & contraindications

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

Indications (1)

• Non-squamous non-small cell lung cancer (NSCLC)

Mechanism & targets

Molecular targets (2)

Target	Gene	Action	Activity
Epidermal growth factor receptor	EGFR	inhibitor	IC50 9.82
Receptor tyrosine-protein kinase erbB-2	ERBB2	inhibitor	IC50 8.53

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
2025-11-01	FDA	—	Bayer HealthCare Pharmaceuticals Inc.	Yes

ATC classification

ATC code	Therapeutic hierarchy
L01EH06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › PROTEIN KINASE INHIBITORS › Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors

Chemical structure

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

• Molecular formula: C₂₄H₂₅ClN₄O₅
• Molecular weight: 484.94 g/mol
• CAS number: —
• InChIKey: VYQVHWNNPKOJEA-AWEZNQCLSA-N
• PubChem CID: 155234713

COC1=C(C=CC=C1Cl)NC2=C(NC3=C2C(=O)NCC3)C4=C(C=NC=C4)OC[C@@H]5COCCO5

Frequently asked questions

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

What is Sevabertinib used for?

DrugCentral lists the following indications for Sevabertinib: Non-squamous non-small cell lung cancer (NSCLC).

How does Sevabertinib work?

Its molecular targets in DrugCentral include EGFR (inhibitor) and ERBB2 (inhibitor).

When was Sevabertinib first approved?

Sevabertinib was first approved by the FDA in 2025.

What is the chemical formula of Sevabertinib?

Sevabertinib has the molecular formula C24H25ClN4O5 and a molecular weight of 484.94 g/mol.

Sources

• DrugCentral drug card 5790 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL6068074 — compound record and bioactivity
• PubChem CID 155234713 — chemical identifiers
• FDA UNII 2A7VPM5RWH — substance identity
• DailyMed: FDA labels for Sevabertinib — current prescribing information (label search)
• UniProt P00533 (EGFR) — target protein
• UniProt P04626 (ERBB2) — target protein

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