Butenafine
As of the edition of 20 October 2026, Butenafine is a small molecule: marketed, first approved in 1996 (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 1996
- Kind
- Small molecule
- Brand name
- Mentax
- First approved
- 18 October 1996 (US)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Pharmobedient Consulting; 3 holders in all
- Registered trials
- 7, 1 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Infections
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 1 | 2 | 1 | 0 | 1 |
| Phase 2 | 1 | 0 | 0 | 0 |
| Phase 3 | 4 | 4 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Later holder | 2001 to now |
| Bayer | Acquired holder and Lead sponsor of trials | 2013 to now |
| Pharmobedient Consulting | Acquired holder | 2025 to now |