Hyrnuo

(Sevabertinib)

Small molecule

Bayer

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Study completion

NCT07753252

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

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

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

Unspecified1 trial

Phase 1, Open-label, Fixed-sequence Crossover Study to Investigate the Effect of Sevabertinib on the Pharmacokinetics of Metformin in Healthy Participants

Not yet recruiting· Bayer logo

Bayer·Phase 1·NCT07753252·40 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 19, 2025

HYRNUO

NDA NDA219972

Sources

References

[1]
ClinicalTrials.gov — 4 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]
OpenFDA — FDA approval records (NDA NDA219972). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Hyrnuo. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Bayer

Patent Landscape[4]

Patent Cliff

Oct 10, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10428063Oct 10, 2035

12679836Nov 13, 2043