Teriflunomide
As of the edition of 20 October 2026, Teriflunomide is a small molecule: marketed, first approved in 2012 (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 2019
- Kind
- Small molecule
- Brand name
- Aubagio
- First approved
- 12 September 2012 (US)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 38, 3 stopped early
- Disease areas
- Immune system; Nervous system; Blood and lymph; Cancer; Pregnancy and women's health; Skin and connective tissue
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DHODH | Dihydroorotate dehydrogenase | Q02127 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 7 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 11 | 6 | 2 | 1 |
| Phase 3 | 10 | 9 | 0 | 1 |
| Phase 4 | 6 | 5 | 1 | 0 |
| All trials | 38 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 2001 to now |