Sparsentan
As of the edition of 20 October 2026, Sparsentan is a small molecule: marketed, first approved in 2023 (US); acts on AGTR1; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Filspari
- First approved
- 17 February 2023 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- CSL Behring; 3 holders in all
- Registered trials
- 12, 0 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Immune system; Heart and blood vessels; Skin and connective tissue; Blood and lymph
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Retrophin.
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 product8 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 Sparsentan.
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 |
|---|---|---|
| AGTR1 | Type-1 angiotensin II receptor | P30556 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 7 | 4 | 3 | 0 |
| Phase 3 | 2 | 1 | 1 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Retrophin | Originator and Lead sponsor of trials | 2014 to now |
| CSL Behring | Applicant | 2024 to now |