Glycerol phenylbutyrate
As of the edition of 20 October 2026, Glycerol phenylbutyrate is a small molecule: marketed, first approved in 2013 (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 2025
- Kind
- Small molecule
- Brand name
- Ravicti
- First approved
- 1 February 2013 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- OrphanPacific, Inc.; 4 holders in all
- Registered trials
- 20, 0 stopped early
- Disease areas
- Nervous system; Nutrition and metabolism; Inherited and neonatal; Digestive system; Eye
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 | 0 | 1 | 0 |
| Phase 1 | 6 | 4 | 1 | 0 |
| Phase 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 4 | 3 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant, Acquired holder and Lead sponsor of trials | 2005 to now |
| Immedica Pharma | Applicant | 2015 to now |