Brexanolone
As of the edition of 20 October 2026, Brexanolone is a small molecule: marketed, first approved in 2019 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Zulresso
- First approved
- 17 June 2019 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Sage Therapeutics Llc A Wholly Owned Sub Of Supernus Pharmaceuticals
- Registered trials
- 27, 6 stopped early
- Disease areas
- Mental health; Nervous system; Pregnancy and women's health; Urinary and reproductive; Injuries; Chemically induced
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 0 | 0 |
| Phase 1 | 5 | 3 | 1 | 1 |
| Phase 2 | 11 | 7 | 3 | 1 |
| Phase 3 | 4 | 2 | 1 | 1 |
| Phase 4 | 4 | 1 | 0 | 3 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Supernus Pharmaceuticals | Originator and Lead sponsor of trials | 2014 to now |
| Sage Therapeutics Llc A Wholly Owned Sub Of Supernus Pharmaceuticals | Acquired holder | 2026 to now |