Ponesimod
As of the edition of 20 October 2026, Ponesimod is a small molecule: marketed, first approved in 2021 (US); acts on S1PR1; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Ponvory
- First approved
- 18 March 2021 (US)
- Approvals on record
- 13 in 3 regions
- Holder of the most recent approval
- Laboratoires Juvisé Pharmaceuticals; 2 holders in all
- Registered trials
- 18, 2 stopped early
- Disease areas
- Immune system; Nervous system; Skin and connective tissue; Digestive system; Lungs and airways
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Vanda Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product30 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ponesimod.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| S1PR1 | Sphingosine 1-phosphate receptor 1 | P21453 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 1 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 5 | 4 | 0 | 1 |
| Phase 3 | 5 | 2 | 2 | 1 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator and Lead sponsor of trials | 2008 to now |
| Laboratoires Juvisé Pharmaceuticals | Applicant | 2021 to now |
| Vanda Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2024 to now |