Fosdenopterin
As of the edition of 20 October 2026, Fosdenopterin is a small molecule: marketed, first approved in 2021 (US); acts on MOCS1; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Nulibry
- First approved
- 26 February 2021 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- TMC Pharma; 2 holders in all
- Registered trials
- 2, 1 stopped early
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Sentynl Therapeutics.
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
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 Fosdenopterin.
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 |
|---|---|---|
| MOCS1 | Molybdenum cofactor biosynthesis protein 1 | Q9NZB8 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 0 | 0 | 1 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bridgebio Pharma | Originator and Lead sponsor of trials | 2013 to now |
| Sentynl Therapeutics | Acquired holder | 2022 to now |
| TMC Pharma | Applicant | 2022 to now |