Alcohol
As of the edition of 20 October 2026, Alcohol is a small molecule: marketed, first approved in 1982 (US); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Small molecule
- Brand name
- Avagard
- First approved
- 1 January 1982 (US)
- Approvals on record
- 9 in 3 regions
- Holder of the most recent approval
- Be Biopharma; 6 holders in all
- Registered trials
- 154, 16 stopped early
- Disease areas
- Mental health; Chemically induced; Infections; Cancer; Digestive system; Nutrition and metabolism
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Be Biopharma holds a later exclusivity on its own new formulation or combination product, ending 2032; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 52 | 30 | 15 | 5 |
| Phase 1 | 58 | 39 | 12 | 5 |
| Phase 2 | 21 | 12 | 4 | 5 |
| Phase 3 | 13 | 5 | 4 | 1 |
| Phase 4 | 10 | 8 | 0 | 0 |
| All trials | 154 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| B. Braun Medical | Applicant | 2000 to now |
| Bpi | Acquired holder | 2022 to now |
| Be Biopharma | Acquired holder | 2026 to now |