BLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Aug 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
NPLATE (romiplostim) by Amgen is thrombopoietin receptor agonists [moa]. First approved in 2008.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NPLATE (romiplostim) is a thrombopoietin receptor agonist approved in 2008 as a subcutaneous injectable fusion protein developed by Amgen. It works by binding to and activating the thrombopoietin receptor on megakaryocytes, thereby stimulating platelet production. NPLATE is indicated for patients with immune thrombocytopenia (ITP) and is a foundational therapy in the TPO-RA class, positioned as a standard-of-care option for chronic ITP management.
$0.0BPart D
Mechanism of Action
Thrombopoietin Receptor Agonists
Pharmacologic Class:
Thrombopoietin Receptor Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia
Started Aug 2026
15 enrolled
Aplastic Anemia
CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA
Started Apr 2026
43 enrolled
Severe Aplastic Anemia (SAA)Transfusion-dependent Non-severe Aplastic Anemia
Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA
Started Apr 2026
43 enrolled
Aplastic Anemia
Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy
Started Apr 2026
28 enrolled
Primary Immune Thrombocytopenia (ITP)
CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA
Started Apr 2026
43 enrolled
Severe Aplastic Anemia (SAA)Transfusion-dependent Non-severe Aplastic Anemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.