Andexanet alfa
As of the edition of 20 October 2026, Andexanet alfa is a protein: marketed, first approved in 2018 (US); acts on TFPI; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Protein
- Brand name
- Andexxa
- First approved
- 3 May 2018 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- AstraZeneca
- Registered trials
- 17, 3 stopped early
- Disease areas
- Heart and blood vessels
US protection
US protection ends in 2030.
US protection ends in 2030, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by AstraZeneca. The date is computed, not published.
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.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| TFPI | Tissue factor pathway inhibitor | P10646 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 7 | 5 | 0 | 2 |
| Phase 3 | 4 | 3 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 2015 to now |