Lusutrombopag
As of the edition of 20 October 2026, Lusutrombopag is a small molecule: marketed, first approved in 2015 (JP); acts on MPL; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Mulpleta
- First approved
- 28 September 2015 (JP)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Shionogi
- Withdrawn from market
- 14 April 2026 (in some regions)
- Registered trials
- 8, 2 stopped early
- Disease areas
- Blood and lymph; Immune system
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Shionogi.
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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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Lusutrombopag.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MPL | Thrombopoietin receptor | P40238 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 1 | 1 | 2 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Shionogi | Applicant and Lead sponsor of trials | 2009 to now |