Vadadustat
As of the edition of 20 October 2026, Vadadustat is a small molecule: marketed, first approved in 2020 (JP); acts on EGLN1 and EGLN2; US protection ends in 2034.
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
- Vafseo
- First approved
- 29 June 2020 (JP)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Akebia Therapeutics; 3 holders in all
- Registered trials
- 40, 4 stopped early
- Disease areas
- Blood and lymph; Pregnancy and women's health; Urinary and reproductive; Infections; Lungs and airways
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Akebia 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 product24 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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Vadadustat.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 11 | 11 | 0 | 0 |
| Phase 2 | 10 | 9 | 0 | 1 |
| Phase 3 | 18 | 12 | 3 | 3 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Akebia Therapeutics | Applicant and Lead sponsor of trials | 2010 to now |
| Mitsubishi Tanabe Pharma | Applicant | 2020 to now |
| Medice Arzneimittel Pütter | Applicant | 2023 to now |