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Peptide

Romiplostim (Nplate)

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.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
10
Graded outcomes
4312

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Immune Thrombocytopenia: outcomes studied for Romiplostim (Nplate)
GradeOutcomeEffectSizeStudiesPeopleStudies list
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.

Improves (the measure goes down)Large effect16 studies

Studies that measured bleeding reduction

and 6 more in the citations list

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).

Improves (the measure goes up)Large effect15 studies

Studies that measured durable platelet response

and 5 more in the citations list

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.

Improves (the measure goes up)Large effect15 studies

Studies that measured overall platelet response

and 5 more in the citations list

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.

Improves (the measure goes up)Large effect15 studies

Studies that measured long-term efficacy

and 5 more in the citations list

General

General: outcomes studied for Romiplostim (Nplate)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Immune Function

46 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect21 studies

Studies that measured immune function

and 11 more in the citations list

Safety/Tolerability

9 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect15 studies

Studies that measured safety/tolerability

and 5 more in the citations list

Anti-Cancer Activity

8 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect14 studies

Studies that measured anti-cancer activity

and 4 more in the citations list

Reproductive Outcomes

4 systematic reviews and preclinical studies support this finding. Evidence includes systematic reviews/meta-analyses. Primarily preclinical evidence.

Improves (the measure goes up)Small effect10 studies
Liver Protection

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect8 studies
Mortality

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes down)Small effect8 studies

Key findings

  • Bleeding ReductionImmune ThrombocytopeniaImproves (the measure goes down)
  • Durable Platelet ResponseImmune ThrombocytopeniaImproves (the measure goes up)
  • Overall Platelet ResponseImmune ThrombocytopeniaImproves (the measure goes up)

Safety notes in the studies

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

Studies cited

58 studies from PubMed

  1. Role of thrombopoietin receptor agonists in chemotherapy-induced thrombocytopenia: A meta-analysis.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2025 · PMID 38155484
  2. Chemotherapy-induced thrombocytopenia: modern diagnosis and treatment.British journal of haematology, 2025 · PMID 40040262
  3. Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System.BMC pharmacology & toxicology, 2025 · PMID 40016824
  4. Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA.Blood advances, 2025 · PMID 40101243
  5. Comparative efficacy and safety of rhTPO, romiplostim, and eltrombopag in the treatment of pediatric primary immune thrombocytopenia: a systematic review and network meta-analysis.Frontiers in immunology, 2025 · PMID 40547032
  6. Predictive factors of romiplostim response in patients with refractory aplastic anemia: data from two clinical trials.Annals of hematology, 2025 · PMID 40593138
  7. Romiplostim with ciclosporin A in patients with aplastic anaemia naïve to immunosuppressive therapy: A phase 2/3 study.British journal of haematology, 2025 · PMID 40639944
  8. Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in ChinaHaematologica, 2024 · PMID 37601010
  9. Romiplostim in chemotherapy-induced thrombocytopenia: A review of the literature.Cancer medicine, 2024 · PMID 39135303
  10. Immune thrombocytopenia and pregnancy: challenges and opportunities in diagnosis and management.Expert review of hematology, 2024 · PMID 39105265
  11. Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings.International journal of hematology, 2024 · PMID 39342544
  12. A Review on Romiplostim Mechanism of Action and the Expressive Approach in E. coli.Recent patents on biotechnology, 2024 · PMID 38282441
  13. Survival and Hematologic Benefits of Romiplostim After Acute Radiation Exposure Supported FDA Approval Under the Animal Rule.International journal of radiation oncology, biology, physics, 2023 · PMID 37224926
  14. Romiplostim use in pregnant women with immune thrombocytopenia.American journal of hematology, 2023 · PMID 36156812
  15. Romiplostim drug presence in pregnancy and lactation.Blood, 2023 · PMID 36848631
  16. Safety of romiplostim and eltrombopag for children with immune thrombocytopenia: a pharmacovigilance study of the FDA adverse event reporting system database.Expert opinion on drug safety, 2023 · PMID 36803342
  17. Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in Patients with Chronic Immune Thrombocytopenia.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion, 2023 · PMID 37304488
  18. Safety of romiplostim administered immediately after cord-blood transplantation: a phase 1 trial.Annals of hematology, 2023 · PMID 37589942
  19. Romiplostim for Primary Immune Thrombocytopenia in Routine Clinical Practice: Results from a Multicentre Observational Study in GermanyPharmaceuticals (Basel), 2022 · PMID 35940802
  20. Romiplostim for PARP inhibitor-induced thrombocytopenia in solid tumor malignancies.Platelets, 2022 · PMID 36050822
  21. Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of a Romiplostim Biosimilar in Chronic Refractory Immune Thrombocytopenic Purpura (ITP) Patients.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion, 2022 · PMID 35125719
  22. Efficacy and quality of life of Romiplostim in adults and children with immune thrombocytopenia: A review.Medicine, 2022 · PMID 36550870
  23. A multicenter study of romiplostim for chemotherapy-induced thrombocytopenia in solid tumors and hematologic malignancies.Haematologica, 2021 · PMID 32499239
  24. Thrombopoietin level predicts response to treatment with romiplostim in chemotherapy-induced thrombocytopenia.American journal of hematology, 2021 · PMID 34453757
  25. Efficacy and safety of romiplostim in refractory aplastic anaemia: a Phase II/III, multicentre, open-label study.British journal of haematology, 2021 · PMID 33152120
  26. A Review of Romiplostim Mechanism of Action and Clinical Applicability.Drug design, development and therapy, 2021 · PMID 34079225
  27. Experts' review: the emerging roles of romiplostim in immune thrombocytopenia (ITP).Expert opinion on biological therapy, 2021 · PMID 34313512
  28. Assessment of romiplostim immunogenicity in pediatric patients in clinical trials and in a global postmarketing registry.Blood advances, 2021 · PMID 34638135
  29. Romiplostim (Nplate(®)) as an effective radiation countermeasure to improve survival and platelet recovery in mice.International journal of radiation biology, 2020 · PMID 31021662
  30. Use of Romiplostim during pregnancy as a rescue therapy in primary immune thrombocytopenia: Literature review and case description.Platelets, 2020 · PMID 31116059
  31. Romiplostim in patients undergoing hematopoietic stem cell transplantation: results of a phase 1/2 multicenter trial.Blood, 2020 · PMID 31805185
  32. Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry.British journal of haematology, 2020 · PMID 32311075
  33. Romiplostim treatment for children with immune thrombocytopenia: Results of an integrated database of five clinical trials.Pediatric blood & cancer, 2020 · PMID 32902132
  34. Romiplostim Treatment of Chemotherapy-Induced ThrombocytopeniaJ Clin Oncol, 2019 · PMID 31545663
  35. Romiplostim-related myelofibrosis in refractory primary immune thrombocytopenia: A Case report.Medicine, 2019 · PMID 31232923
  36. Romiplostim for Immune Thrombocytopenia in Neuroblastoma Patients Receiving Chemotherapy.Journal of pediatric hematology/oncology, 2019 · PMID 29683946
  37. Eltrombopag versus romiplostim in treatment of children with persistent or chronic immune thrombocytopenia: a systematic review incorporating an indirect-comparison meta-analysis.Scientific reports, 2018 · PMID 29330464
  38. Eltrombopag versus romiplostim in treatment of adult patients with immune thrombocytopenia: A systematic review incorporating an indirect-comparison meta-analysis.PloS one, 2018 · PMID 29856837
  39. Efficacy of romiplostim in the treatment of ITP in children: a meta-analysis.European review for medical and pharmacological sciences, 2018 · PMID 30280805
  40. Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled studyLancet, 2016 · PMID 27103127
  41. Romiplostim for management of chemotherapy-induced thrombocytopenia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014 · PMID 24414994
  42. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacyBr J Haematol, 2013 · PMID 23432528
  43. Romiplostim-induced myelofibrosis.Blood, 2013 · PMID 24175353
  44. Romiplostim: a review of its use in immune thrombocytopenia.Drugs, 2012 · PMID 22316355
  45. The burden of immune thrombocytopenia in adults: evaluation of the thrombopoietin receptor agonist romiplostim.Journal of medical economics, 2012 · PMID 22533524
  46. Romiplostim and eltrombopag for immune thrombocytopenia: methods for indirect comparison.International journal of technology assessment in health care, 2012 · PMID 22980701
  47. Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinical trialInt J Hematol, 2011 · PMID 21706145
  48. The development of romiplostim for patients with immune thrombocytopenia.Annals of the New York Academy of Sciences, 2011 · PMID 21434943
  49. Evaluation of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic immune thrombocytopenia (ITP)J Thromb Haemost, 2010 · PMID 20230419
  50. Romiplostim or standard of care in patients with immune thrombocytopeniaN Engl J Med, 2010 · PMID 19005182
  51. Development of romiplostim for the treatment of patients with chronic immune thrombocytopenia: from bench to bedside.British journal of haematology, 2010 · PMID 20298251
  52. Romiplostim: a breakthrough treatment for the management of immune thrombocytopenic purpura.European journal of haematology. Supplementum, 2009 · PMID 19200304
  53. Romiplostim management of immune thrombocytopenic purpura.The Annals of pharmacotherapy, 2009 · PMID 19401474
  54. Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura.Oncology (Williston Park, N.Y.), 2009 · PMID 19711585
  55. Romiplostim for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a single technology appraisal.Health technology assessment (Winchester, England), 2009 · PMID 19804691
  56. Romiplostim in chronic immune thrombocytopenic purpura.Clinical therapeutics, 2009 · PMID 19843480
  57. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trialLancet, 2008 · PMID 18242413
  58. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITPN Engl J Med, 2006 · PMID 17942755