Clofazimine
As of the edition of 20 October 2026, Clofazimine is a small molecule: marketed, first approved in 1969 (CH).
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
- Lamprene
- First approved
- 24 April 1969 (CH)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 38, 5 stopped early
- Disease areas
- Infections; Lungs and airways; Immune system; Urinary and reproductive; Digestive system; Animal diseases
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 | 9 | 6 | 1 | 0 |
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 2 | 11 | 4 | 4 | 2 |
| Phase 3 | 14 | 8 | 3 | 2 |
| Phase 4 | 3 | 1 | 0 | 1 |
| All trials | 38 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GEIGY Pharmaceuticals | Applicant | 1986 to now |
| Novartis | Acquired holder and Lead sponsor of trials | 2003 to now |