Fospropofol
As of the edition of 20 October 2026, Fospropofol is a small molecule: marketed, first approved in 2008 (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 2008
- Kind
- Small molecule
- Brand name
- Lusedra
- First approved
- 12 December 2008 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Eisai
- Registered trials
- 26, 5 stopped early
- Disease areas
- Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Bones, joints and muscles; Inherited and neonatal; Lungs and airways
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 | 1 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 6 | 4 | 0 | 1 |
| Phase 3 | 8 | 6 | 0 | 2 |
| Phase 4 | 8 | 3 | 4 | 1 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eisai | Acquired holder and Lead sponsor of trials | 2002 to now |