Dapsone
As of the edition of 20 October 2026, Dapsone is a small molecule: marketed, first approved in 1951 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2005
- Kind
- Small molecule
- Brand name
- Aczone
- First approved
- 1 February 1951 (ES)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Almirall; 5 holders in all
- Registered trials
- 59, 7 stopped early
- Disease areas
- Skin and connective tissue; Infections; Immune system; Lungs and airways; Urinary and reproductive; Blood and lymph
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 | 7 | 5 | 0 | 1 |
| Phase 1 | 12 | 9 | 0 | 2 |
| Phase 2 | 7 | 4 | 1 | 2 |
| Phase 3 | 20 | 17 | 0 | 1 |
| Phase 4 | 13 | 10 | 0 | 1 |
| All trials | 59 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Later holder and Lead sponsor of trials | 2005 to now |
| Qlt | Applicant | 2005 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2006 to now |
| Almirall | Acquired holder and Lead sponsor of trials | 2013 to now |