Hyrnuo

(Sevabertinib)

Phase 3Small molecule

Bayer

Hyrnuo is one of 5 small molecule programs targeting HER2 Mutation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HER2 MutationRecruiting

HER2 MutationPhase 3

Recruiting

Competition

Competitive Landscape

4 competitors in HER2 Mutation

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

1 2

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

1 3

Paraplatin

AAvyxa

Phase 3

1 4

Alimta

GGynecologic Oncology Group

Phase 3

1 5

Hyrnuo

Bayer

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2029

Phase 3Recruiting

HER2 Mutation

NCT06452277

Clinical

Trials by Indication[1]

Absorption1 trial

A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose

Completed· Bayer logo

Bayer·Phase 1·NCT07102095·18 enrolled

Advanced Non-Small Cell Lung Cancer1 trial

An Expanded Access Program to Provide Oral Sevabertinib (BAY 2927088) in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring an HER2 (Human Epidermal Growth Factor Receptor 2) Activating Mutation

Available· Bayer logo

Bayer··NCT06761976

HER2 Mutation1 trial

A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations

Recruiting· Bayer logo

Bayer·Phase 3·NCT06452277·444 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 19, 2025

HYRNUO

NDA NDA219972

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Sevabertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sevabertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sevabertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219972). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Hyrnuo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bayer

Patent Landscape[5]

Patent Cliff

Oct 10, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10428063Oct 10, 2035

Hyrnuo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2029

Trials by Indication[1]

Absorption1 trial

Advanced Non-Small Cell Lung Cancer1 trial

HER2 Mutation1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News