Drugs / Sevabertinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HYRNUO | — | 2025-11-19 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07102095 | Jul → Dec 2025 | liver disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06360211 | Apr → Jun 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06348888 | Apr → Jun 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06378658 | Mar → Jun 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06329895 | Mar → Jun 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06221475 | Jan → Apr 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05099172 | Oct 2021 → Mar 2026 overdue | non-small cell lung carcinoma | Bayer | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06760819 | Feb 2025 → Feb 2029 expected | cancer | Bayer | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06452277 | Aug 2024 → Oct 2027 expected | lung cancer | Bayer | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06761976 | — | non-small cell lung carcinoma | Bayer | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | Bayer | Regulatory U.S. FDA grants accelerated approval to Bayer’s targeted therapy sevabertinib as a first-line treatment option for adults with HER2-mutant non-small cell lung cancer bayer.com ↗ |
| 2026-08-24 | Bayer | Regulatory Bayer’s sevabertinib approved in Japan for patients with HER2-mutant non-small cell lung cancer bayer.com ↗
The Ministry of Health, Labour, and Welfare (MHLW) in Japan has granted approval for Hyrnuo™ (sevabertinib) for the treatment of patients with HER2 (ERBB2) mutation-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC). |
| 2026-05-18 | Bayer | Regulatory FDA grants sevabertinib Priority Review as a first-line treatment for patients with HER2-mutant non-small cell lung cancer bayer.com ↗
The U.S. Food and Drug Administration (FDA) has granted sevabertinib Priority Review designation, recognizing its potential to address a critical unmet need. |
| 2026-01-06 | Bayer | Regulatory Bayer receives Breakthrough Therapy Designation in the U.S. and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer bayer.com ↗ |
| 2025-11-20 | Bayer | Regulatory Accelerated approval in the U.S. for new treatment for patients with previously treated advanced HER2-mutant non-small cell lung cancer bayer.com ↗
U.S. FDA grants accelerated approval to Bayer’s HYRNUO™ (sevabertinib) for patients with previously treated advanced HER2-mutant non-small cell lung cancer |
| 2025-07-28 | Bayer | Regulatory Bayer’s sevabertinib (BAY 2927088) accepted for review in China bayer.com ↗ |
| 2025-05-28 | Bayer | Regulatory Sevabertinib (BAY 2927088) granted FDA Priority Review for the treatment of patients with HER2-mutant non-small cell lung cancer bayer.com ↗
Bayer today announced that the investigational compound sevabertinib (BAY 2927088) has been granted Priority Review status by the US Food and Drug Administration (FDA) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2/ERBB2) mutations and who have received a prior systemic therapy. |
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sevabertinib | “Sevabertinib is an oral, reversible tyrosine kinase inhibitor that has shown anti-HER2 activity in preclinical models.” PMID 41104928 ↗ Oct 2025 |
| Known as | BAY 2927088 | “A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy...” NCT06348888 ↗9“A Phase 1, Open Label, Fixed Sequence, Crossover Study to Investigate the Effect of BAY 2927088 on the Pharmacokinetics of Midazolam in Healthy Participants” NCT06360211 ↗ “A Phase 1, Open-label, Single-dose Study to Assess the Influence of Hepatic Impairment on the Pharmacokinetics of of Sevabertinib (BAY 2927088)” NCT07102095 ↗ “The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.” NCT05099172 ↗ |
| Action | Inhibit | “The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.” NCT05099172 ↗ |
| Modality | Small molecule | “Sevabertinib is an oral, reversible tyrosine kinase inhibitor that has shown anti-HER2 activity in preclinical models.” PMID 41104928 ↗ Oct 2025 |
| Route | Oral | “The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a...” NCT05099172 ↗ |
| Target | EGFR | “The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.” NCT05099172 ↗ |