Selexipag
As of the edition of 20 October 2026, Selexipag is a small molecule: marketed, first approved in 2015 (US); acts on PTGIR; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Uptravi
- First approved
- 21 December 2015 (US)
- Approvals on record
- 25 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Registered trials
- 27, 3 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Blood and lymph; Immune system; Infections; Skin and connective tissue
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Johnson & Johnson.
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 product42 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 42 listings behind itRequest access. Nothing is shown until you do.
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 Selexipag.
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 |
|---|---|---|
| PTGIR | Prostacyclin receptor | P43119 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 10 | 10 | 0 | 0 |
| Phase 2 | 4 | 1 | 1 | 1 |
| Phase 3 | 9 | 6 | 2 | 1 |
| Phase 4 | 2 | 1 | 0 | 1 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2015 to now |
| Nippon Shinyaku | Applicant | 2016 to now |