Romiplostim (Nplate)

Peptide

Romiplostim is a recombinant Fc-peptide fusion protein thrombopoietin receptor agonist. FDA-approved 2008 for chronic ITP, 2018 for pediatric ITP. Phase 3: 88% overall platelet response vs 14% placebo in non-splenectomized patients. Durable response in 52% pediatric patients vs 10% placebo. Weekly SC injection maintains platelets ≥50,000/μL.

Quick Answer

What it is

Romiplostim is a recombinant Fc-peptide fusion protein thrombopoietin receptor agonist. FDA-approved 2008 for chronic ITP, 2018 for pediatric ITP.

Key findings

  • Grade A: Durable Platelet Response (Immune Thrombocytopenia)
  • Grade A: Overall Platelet Response (Immune Thrombocytopenia)
  • Grade A: Long-term Efficacy (Immune Thrombocytopenia)

Safety

  • Safe long-term with no increased thrombosis or malignancy risk.
⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Romiplostim (Nplate)

Quick Facts: Romiplostim (Nplate)

  • Best Evidence:Grade A
  • Conditions Studied:1
  • Research Outcomes:10
  • Grade A Findings:4
  • Grade B Findings:3
  • Key Effect:Immune Thrombocytopenia
A4
B3
C1
D2
1 conditions · 10 outcomes

Detailed Outcomes

A
Durable Platelet Response
Phase 3: 38% durable response (≥50,000/μL for ≥6 of last 8 weeks) in splenectomized vs 0% placebo (P=0.0013). 52% durable response in pediatric patients vs 10% placebo (P=0.002, OR 9.1).
largeImproves
A
Overall Platelet Response
Phase 3: 88% non-splenectomized and 79% splenectomized achieved platelet response vs 14% and 0% placebo (P<0.0001). Mean 13.8 weeks with platelets ≥50,000/μL vs 0.8 weeks placebo.
largeImproves
A
Long-term Efficacy
5-year extension: 95% achieved platelet response at least once. Platelet response maintained at median 92% of visits. Stable doses (mean 5-8 μg/kg) with platelets 50-200,000/μL throughout.
largeImproves
A
Bleeding Reduction
Reduced bleeding events vs placebo. Lower rescue medication use. Decreased need for concurrent ITP therapies. Safe long-term with no increased thrombosis or malignancy risk.
largeImproves
B
Immune Function
46 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderateImproves
B
Safety/Tolerability
9 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderateImproves
B
Anti-Cancer Activity
8 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.
moderateImproves
C
Reproductive Outcomes
4 systematic reviews and preclinical studies support this finding. Evidence includes systematic reviews/meta-analyses. Primarily preclinical evidence.
smallImproves
D
Liver Protection
2 preclinical studies support this finding. Primarily preclinical evidence.
smallImproves
D
Mortality
2 preclinical studies support this finding. Primarily preclinical evidence.
smallImproves

Research Citations (58)

Role of thrombopoietin receptor agonists in chemotherapy-induced thrombocytopenia: A meta-analysis.
(2025)
PMID: 38155484
Chemotherapy-induced thrombocytopenia: modern diagnosis and treatment.
(2025)
PMID: 40040262
Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System.
(2025)
PMID: 40016824
Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA.
(2025)
PMID: 40101243
Comparative efficacy and safety of rhTPO, romiplostim, and eltrombopag in the treatment of pediatric primary immune thrombocytopenia: a systematic review and network meta-analysis.
(2025)
PMID: 40547032
Predictive factors of romiplostim response in patients with refractory aplastic anemia: data from two clinical trials.
(2025)
PMID: 40593138
Romiplostim with ciclosporin A in patients with aplastic anaemia naïve to immunosuppressive therapy: A phase 2/3 study.
(2025)
PMID: 40639944
Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China
(2024)
PMID: 37601010
Romiplostim in chemotherapy-induced thrombocytopenia: A review of the literature.
(2024)
PMID: 39135303
Immune thrombocytopenia and pregnancy: challenges and opportunities in diagnosis and management.
(2024)
PMID: 39105265