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 · a red edge is where a trial was stopped
| 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 2027 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 |
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 ↗ |