Miltefosine
As of the edition of 20 October 2026, Miltefosine is a small molecule: marketed, first approved in 2014 (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
- Impavido
- First approved
- 19 March 2014 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Knight Therapeutics
- Registered trials
- 41, 5 stopped early
- Disease areas
- Infections; Skin and connective tissue; Immune system; Injuries
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 | 6 | 3 | 1 | 2 |
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 2 | 20 | 13 | 1 | 3 |
| Phase 3 | 12 | 11 | 0 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Knight Therapeutics | Acquired holder and Lead sponsor of trials | 2010 to now |
| Endo | Originator | 2014 to 2015 |