Tagraxofusp
As of the edition of 20 October 2026, Tagraxofusp is a protein: marketed, first approved in 2018 (US); acts on EEF2 and IL3RA; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Elzonris
- First approved
- 21 December 2018 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Nippon Shinyaku; 3 holders in all
- Registered trials
- 23, 7 stopped early
- Disease areas
- Blood and lymph; Cancer; Skin and connective tissue; Immune system; Heart and blood vessels; Infections
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 Stemline Therapeutics. 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.
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 Tagraxofusp.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 7 | 0 | 5 | 2 |
| Phase 2 | 15 | 3 | 7 | 5 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Stemline Therapeutics | Applicant and Lead sponsor of trials | 2014 to now |
| Nippon Shinyaku | Applicant | 2025 to now |