Propofol
As of the edition of 20 October 2026, Propofol is a small molecule: marketed, first approved in 1986 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Diprivan
- First approved
- 8 September 1986 (CH)
- Approvals on record
- 8 in 6 regions
- Holder of the most recent approval
- ASPEN PHARMA INDÚSTRIA FARMACÊUTICA LTDA; 7 holders in all
- Registered trials
- 633, 51 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Lungs and airways; Heart and blood vessels; Digestive system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 325 | 193 | 32 | 31 |
| Phase 1 | 32 | 18 | 6 | 2 |
| Phase 2 | 27 | 15 | 5 | 5 |
| Phase 3 | 40 | 32 | 1 | 3 |
| Phase 4 | 209 | 112 | 26 | 10 |
| All trials | 633 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Earlier holder | 1989 to now |
| B. Braun Medical | Applicant | 2001 to now |
| Baxter Healthcare | Applicant | 2001 to now |
| Fresenius Kabi | Acquired holder and Lead sponsor of trials | 2013 to now |