Atrasentan
As of the edition of 20 October 2026, Atrasentan is a small molecule: marketed, first approved in 2025 (US); acts on EDNRA; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Vanrafia
- First approved
- 2 April 2025 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Novartis
- Registered trials
- 18, 1 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Pregnancy and women's health; Immune system; Hormones; Inherited and neonatal
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. 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 product1 listing counts 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
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 Atrasentan.
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 |
|---|---|---|
| EDNRA | Endothelin-1 receptor | P25101 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 8 | 6 | 1 | 1 |
| Phase 3 | 7 | 5 | 2 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator and Lead sponsor of trials | 2025 to now |