Leflunomide
As of the edition of 20 October 2026, Leflunomide is a small molecule: marketed, first approved in 1998 (US); acts on DHODH; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Arava
- First approved
- 10 September 1998 (US)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Withdrawn from market
- 19 July 2017 (in some regions)
- Registered trials
- 73, 7 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Bones, joints and muscles; Cancer; Blood and lymph; Heart and blood vessels
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.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Leflunomide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DHODH | Dihydroorotate dehydrogenase | Q02127 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 3 | 2 | 1 |
| Phase 1 | 15 | 7 | 5 | 2 |
| Phase 2 | 22 | 8 | 8 | 3 |
| Phase 3 | 11 | 9 | 0 | 1 |
| Phase 4 | 12 | 9 | 1 | 0 |
| All trials | 73 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 1998 to now |
| Zentiva k.s | Applicant | 2010 to now |