Treosulfan
As of the edition of 20 October 2026, Treosulfan is a small molecule: marketed, first approved in 2019 (EU); US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Grafapex
- First approved
- 20 June 2019 (EU)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Medexus Pharma; 2 holders in all
- Registered trials
- 41, 1 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Nutrition and metabolism; Inherited and neonatal; Heart and blood vessels
US protection
US protection ends in 2032.
The last listed US exclusivity ends in 2032. The application that gives this date is held by Medexus Pharma.
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 product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 32 | 14 | 8 | 1 |
| Phase 3 | 7 | 3 | 1 | 0 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| medac Gesellschaft für klinische Spezialpräparate mbH | Applicant | 2019 to now |
| Medexus Pharma | Applicant | 2025 to now |