Unoprostone isopropyl
As of the edition of 20 October 2026, Unoprostone isopropyl is a small molecule: marketed, first approved in 2000 (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 2000
- Kind
- Small molecule
- Brand name
- Rescula
- First approved
- 3 August 2000 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Byk-Mallinckrodt CIL
- Registered trials
- 2, 1 stopped early
- Disease areas
- Eye; Inherited and neonatal
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 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 0 | 0 | 1 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Byk-Mallinckrodt CIL | Acquired holder and Lead sponsor of trials | 2011 to now |