BLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Aug 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
NPLATE (romiplostim) by Amgen is thrombopoietin receptor agonists [moa]. Approved for thrombopoietin receptor agonist [epc]. First approved in 2008.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NPLATE (romiplostim) is a thrombopoietin receptor agonist administered subcutaneously to treat immune thrombocytopenia (ITP) by stimulating platelet production. It is a fusion protein that mimics the action of endogenous thrombopoietin, increasing platelet counts in patients with chronic ITP who are refractory to or intolerant of other treatments.
$0.014BPart D
LOE ApproachingAs the product approaches loss of exclusivity, commercial teams are likely consolidating, with focus shifting toward managed care defense and specialty distribution efficiency.
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 the Treatment of Newly-diagnosed SAA/TD-NSAA
Started Jun 2026
0Severe Aplastic Anemia (SAA)Transfusion-dependent Non-severe Aplastic Anemia
Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA
Started Jun 2026
0Aplastic 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 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.