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-dpdRegulatory1 approval record · 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

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 21 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 23 minutes 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.