Romiplostim - Amgen
Alternative Names: AMG-531; Nplate; RomiplateLatest Information Update: 31 Aug 2026
At a glance
- Originator Kirin-Amgen
- Developer Amgen; Kirin-Amgen
- Class Antianaemics; Carrier proteins; Immunotherapies; Radioprotectives; Recombinant fusion proteins; Skin disorder therapies
- Mechanism of Action Thrombopoietin receptor agonists
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Orphan Drug Status
Yes - Idiopathic thrombocytopenic purpura; Radiation injuries; Thrombocytopenia; Aplastic anaemia
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Acute radiation syndrome; Aplastic anaemia; Idiopathic thrombocytopenic purpura
- Phase III Thrombocytopenia
- Phase I/II Myelodysplastic syndromes
Most Recent Events
- 04 Aug 2026 Phase-III clinical trials in Idiopathic thrombocytopenic purpura (Treatment-naive, Combination therapy) (SC) (NCT07700238)
- 13 Jul 2026 Amgen plans a phase III ROMISTER trial for Idiopathic thrombocytopenic purpura (Combination therapy, Treatment naive) (SC) in July 2027 (NCT07700238)
- 30 Sep 2025 Regulatory submission withdrawn for Aplastic anaemia in Taiwan (SC) (Kyowa Kirin pipeline, September 2025)