Luspatercept
As of the edition of 20 October 2026, Luspatercept is a protein: marketed, first approved in 2019 (US); acts on TGFB1, TGFB2 and TGFB3; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Protein
- Brand name
- Reblozyl
- First approved
- 8 November 2019 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Bristol Myers Squibb; 2 holders in all
- Registered trials
- 67, 5 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Cancer; Immune system; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2031.
US protection ends in 2031, 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 Bristol Myers Squibb. 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
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Luspatercept.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 5 | 10 | 3 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 31 | 9 | 20 | 1 |
| Phase 3 | 11 | 2 | 9 | 0 |
| Phase 4 | 5 | 0 | 2 | 1 |
| All trials | 67 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator, Applicant and Lead sponsor of trials | 2013 to now |