Fingolimod
As of the edition of 20 October 2026, Fingolimod is a small molecule: marketed, first approved in 2010 (US); acts on S1PR1, S1PR2 and S1PR3 and 2 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Gilenya
- First approved
- 21 September 2010 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Cycle Pharmaceuticals; 4 holders in all
- Registered trials
- 86, 12 stopped early
- Disease areas
- Nervous system; Immune system; Heart and blood vessels; Cancer; Lungs and airways; Nutrition and metabolism
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
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Fingolimod.
See the 9 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 9 | 1 | 0 |
| Phase 1 | 7 | 7 | 0 | 0 |
| Phase 2 | 17 | 9 | 1 | 4 |
| Phase 3 | 24 | 17 | 3 | 4 |
| Phase 4 | 25 | 17 | 2 | 4 |
| All trials | 86 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2002 to now |
| Mitsubishi Tanabe Pharma | Applicant | 2011 to now |
| Cycle Pharmaceuticals | Acquired holder | 2023 to now |