Romiplostim
As of the edition of 20 October 2026, Romiplostim is a protein: marketed, first approved in 2008 (US); acts on MPL; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Protein
- Brand name
- Nplate
- First approved
- 22 August 2008 (US)
- Approvals on record
- 14 in 6 regions
- Holder of the most recent approval
- Amgen; 5 holders in all
- Registered trials
- 74, 7 stopped early
- Disease areas
- Blood and lymph; Immune system; Cancer; Heart and blood vessels; Hormones; Inherited and neonatal
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Amgen.
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Romiplostim.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| MPL | Thrombopoietin receptor | P40238 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 6 | 2 | 0 |
| Phase 1 | 4 | 2 | 1 | 0 |
| Phase 2 | 34 | 20 | 4 | 6 |
| Phase 3 | 22 | 16 | 4 | 1 |
| Phase 4 | 6 | 2 | 0 | 0 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 2002 to now |
| Kyowa Kirin | Applicant and Lead sponsor of trials | 2006 to now |