Xanomeline
As of the edition of 20 October 2026, Xanomeline is a small molecule: marketed, first approved in 2024 (US); acts on CHRM1 and CHRM4; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Cobenfy
- First approved
- 26 September 2024 (US)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 37, 1 stopped early
- Disease areas
- Mental health; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 0 | 5 | 0 |
| Phase 1 | 6 | 4 | 2 | 0 |
| Phase 2 | 3 | 1 | 2 | 0 |
| Phase 3 | 19 | 7 | 11 | 1 |
| Phase 4 | 4 | 1 | 3 | 0 |
| All trials | 37 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Lead sponsor of trials | 2016 to now |