sevabertinib
Small moleculeapprovedOrphan Drug FDA
Approved
Nov 19, 2025
Clinical trial activity
10 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
7
Phase 2
2
Phase 3
1
Phase 4
0
Earliest trial started Oct 29, 2021 (NCT05099172)
Timeline
Indications
Approved for
Mechanism of action
EGFR inhibitor
Approval history
- approvedPriority reviewNov 19, 2025
Chemistry & pharmacology
Loading structure…
SMILES
COc1c(Cl)cccc1Nc1c(-c2ccncc2OC[C@@H]2COCCO2)[nH]c2c1C(=O)NCC2- Mol. weight
- 484.94 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL6068074 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07102095 | Phase 1 | Jul 24, 2025 | Bayer |
| NCT06760819 | Phase 2 | Feb 13, 2025 | Bayer |
| NCT06452277 | Phase 3 | Aug 28, 2024 | Bayer |
| NCT06360211 | Phase 1 | Apr 17, 2024 | Bayer |
| NCT06348888 | Phase 1 | Apr 10, 2024 | Bayer |
| NCT06378658 | Phase 1 | Mar 29, 2024 | Bayer |
| NCT06329895 | Phase 1 | Mar 25, 2024 | Bayer |
| NCT06221475 | Phase 1 | Jan 25, 2024 | Bayer |
| NCT05099172 | Phase 1 | Oct 29, 2021 | Bayer |
| NCT06761976 | N/A | — | Bayer |
Showing 10 of 10 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 10 | 10 | 4 | 2021 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bayer | For profit | MKTG | Nov 19, 2025 |