AXS-05
As of the edition of 20 October 2026, AXS-05 is a drug known only by a code name: in active development; acts on GRIN2A, SIGMAR1 and SLC6A2 and 1 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2026
- Kind
- Code name only
- Registered trials
- 13, 2 stopped early
- Disease areas
- Mental health; Nervous system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 8 | 6 | 1 | 1 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 13 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Axsome Therapeutics | Lead sponsor of trials | 2016 to now |