Benzoyl peroxide
As of the edition of 20 October 2026, Benzoyl peroxide is a small molecule: marketed, first approved in 1984 (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 2014
- Kind
- Small molecule
- Brand name
- Benzamycin
- First approved
- 26 October 1984 (US)
- Approvals on record
- 22 in 3 regions
- Holder of the most recent approval
- Galderma; 10 holders in all
- Registered trials
- 74, 3 stopped early
- Disease areas
- Skin and connective tissue; Bones, joints and muscles; 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 not stated | 13 | 10 | 0 | 0 |
| Phase 1 | 10 | 9 | 1 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 22 | 19 | 1 | 1 |
| Phase 4 | 26 | 22 | 0 | 2 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 1996 to now |
| GSK | Later holder and Lead sponsor of trials | 2006 to now |
| Maruho | Applicant | 2014 to now |
| Galderma | Later holder | 2016 to now |
| Sol-Gel Technologies | Applicant and Lead sponsor of trials | 2018 to now |
| Pfizer | Acquired holder | 2025 to now |