Siponimod
As of the edition of 20 October 2026, Siponimod is a small molecule: marketed, first approved in 2019 (US); acts on S1PR1; US protection ends in 2028.
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
- Mayzent
- First approved
- 26 March 2019 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 18, 3 stopped early
- Disease areas
- Nervous system; Immune system; Bones, joints and muscles; Skin and connective tissue; Digestive system; Ear, nose and throat
US protection
US protection ends in 2028.
The last listed US drug-substance patent ends in 2028. The application that gives this date is held by Novartis.
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 product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest 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 | 4 | 1 | 2 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 7 | 3 | 1 | 3 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2006 to now |