Drug · Small Molecule

Sevabertinib

CI-DRUG-00000552Explore in graph →NCIt C185187 CHEMBL6068074 CIViC Phase 2

Regulatory

Approvals (3)

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-dpdRegulatory3 approval records from 2 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 HYRNUO (DIN 02563444) under ATC L01EH06 SEVABERTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 24, 2026	health-canada-dpd
US FDA	—	Efficacy supplement 2026-09-09 (see label)	approved	Sep 9, 2026	openfda
US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] , and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HYRNUO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 ( ERBB2 ) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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 18 hours 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 3	2	2	1	7	3	CA, US	Nov 19, 2025	Jan 25, 2024
Malignant Lung Neoplasm	Approved	Phase 3	1	1	1	6	1	US	Nov 19, 2025	Jan 25, 2024

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (2)

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

civicCuratedShowing 1–2 of 2 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
ERBB2 Exon 20 Insertion + ERBB2 Kinase Domain Mutation1
Sevabertinib

Clinical trials

Trials with this intervention (8)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–8 of 8 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
NCT06452277	A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)(SOHO-02)	recruiting	Phase 3	555	BayerINDUSTRY	36	Sep 23, 2026	clinicaltrials
NCT06760819	A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Molecule

Record

Kind: Small Molecule
UNII: 2A7VPM5RWH
Aliases: BAY 2927088, BAY2927088, EGFR/HER2 Mutant-selective Inhibitor BAY2927088, Hyrnuo, HYRNUO, Sevabertinib, SEVABERTINIB

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (3)

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

System	Code	Label
ATC (WHO)	L01EH06	SEVABERTINIB
DIN (Health Canada)	02563444	HYRNUO
DPD drug code	106622	HYRNUO

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.