Taurursodiol
As of the edition of 20 October 2026, Taurursodiol is a small molecule: marketed, first approved in 2022 (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 2022
- Kind
- Small molecule
- Brand name
- Relyvrio
- First approved
- 29 September 2022 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Amylyx Pharmaceuticals
- Registered trials
- 20, 1 stopped early
- Disease areas
- Nutrition and metabolism; Digestive system; Nervous system; Immune system; Cancer; Hormones
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 | 4 | 3 | 1 | 0 |
| Phase 1 | 2 | 0 | 0 | 1 |
| Phase 2 | 9 | 6 | 3 | 0 |
| Phase 3 | 4 | 2 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 20 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Amylyx Pharmaceuticals | Lead sponsor of trials | 2018 to now |
| Humanitas Mirasole | Lead sponsor of trials | 2019 to now |