Cancer & blood Protein

Romiplostim

Also known as: Nplate · AMG 531

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application
Randomized controlled trials 39 of 932 publications on PubMed
Registered clinical trials 123 35 active
Adverse event reports 15,126 11,653 classified as serious
  • Romiplostim is an FDA-approved drug, marketed as Nplate (first approval: August 22, 2008).
  • PubMed lists 932 publications mentioning it, including 39 randomized controlled trials and 34 animal-only studies.
  • ClinicalTrials.gov lists 123 registered studies testing it (35 active).
  • FDA's adverse event system (FAERS) holds 15,126 reports mentioning it; 11,653 classified as serious. Reports do not prove causation.

Research topics

  • Recombinant Fusion Proteins 89
  • Thrombopoietin 89
  • Receptors, Fc 87
  • Receptors, Thrombopoietin 64
  • Purpura, Thrombocytopenic, Idiopathic 49
  • Thrombocytopenia 41
  • Hydrazines 38
  • Benzoates 36
  • Pyrazoles 36
  • Platelet Count 30

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
BLA125268 NPLATE Approved, marketed August 22, 2008 AMGEN

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 932
  • Human (MeSH) 678
  • Animal only 34
  • Clinical trials 81
  • Randomized controlled trials 39
  • Systematic reviews & meta-analyses 45
  • Case reports 207
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
123
Active
35
With posted results
32

Conditions studied

  • Thrombocytopenia 23
  • Idiopathic Thrombocytopenic Purpura 15
  • Aplastic Anemia 12
  • Immune Thrombocytopenia 12
  • Myelodysplastic Syndromes 6
  • Chemotherapy-induced Thrombocytopenia 5
  • Primary Immune Thrombocytopenia 4
  • Primary Immune Thrombocytopenia (ITP) 4
  • Solid Tumors 4
  • Chemotherapy-Induced Thrombocytopenia 4
  • Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) 4
  • Thrombocytopenic Purpura 4
Study Status Phase Start
Efficacy and Safety of Romiplostim N01 for Injection in Promoting Platelet Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation
NCT07829952 The First Affiliated Hospital of Henan University of Science and Technology
Not yet recruiting Phase 2 November 1, 2026
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
NCT07700238 Amgen
Recruiting Phase 3 August 21, 2026
Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents
NCT07854561 Chinese University of Hong Kong
Recruiting Phase 2 August 11, 2026
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
NCT07421167 Novartis Pharmaceuticals
Recruiting Phase 2 August 4, 2026
Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer
NCT07771881 Fudan University
Not yet recruiting Phase 2 Aug 2026
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
NCT07278661 Nantes University Hospital
Recruiting Phase 2 July 16, 2026
A Multicenter Clinical Study of Romiplostim N01 in the Treatment of Sepsis-related Thrombocytopenia
NCT07595133 Shanghai 10th People's Hospital
Not yet recruiting Phase 1 June 1, 2026
Atorvastatin Combined With NAC Plus Romiplostim for Management of ITP
NCT07662525 Peking University People's Hospital
Not yet recruiting N/A June 1, 2026
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
NCT07400250 Peking Union Medical College Hospital
Not yet recruiting Phase 2 April 1, 2026
Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia
NCT07572084 Peking Union Medical College Hospital
Not yet recruiting Phase 2 Apr 2026
Show 40 more studies
Study Status Phase Start
CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA
NCT07558434 Peking Union Medical College Hospital
Not yet recruiting Phase 2 Apr 2026
Romiplostim for Oral TPO-RA Resistant ITP
NCT07612319 The First Affiliated Hospital of Soochow University
Recruiting N/A March 15, 2026
Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
NCT07400341 The First Affiliated Hospital of Soochow University
Recruiting Phase 2 January 31, 2026
A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia
NCT07345000 Qilu Pharmaceutical Co., Ltd.
Not yet recruiting Phase 3 Jan 2026
Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients
NCT07043894 Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Recruiting Phase 2 December 25, 2025
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
NCT07586826 Peking University People's Hospital
Recruiting Phase 2 December 22, 2025
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
NCT07586813 Peking University People's Hospital
Recruiting Phase 2 December 22, 2025
Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children
NCT07214025 Assiut University
Not yet recruiting — November 1, 2025
Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients
NCT07162519 Tianjin Medical University Cancer Institute and Hospital
Not yet recruiting N/A September 20, 2025
Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors
NCT07128576 Zhujiang Hospital
Not yet recruiting Phase 2 September 15, 2025
Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
NCT07206823 The First Affiliated Hospital of Soochow University
Recruiting N/A September 1, 2025
A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors
NCT07185893 Jun wang
Not yet recruiting N/A Sep 2025
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
NCT07063225 Institute of Hematology & Blood Diseases Hospital, China
Recruiting Phase 2 Aug 2025
Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia
NCT06898983 Anhui Provincial Hospital
Recruiting Phase 2 July 14, 2025
Romiplostim N01 for Platelet Recovery After Haploidentical HSCT
NCT07321626 First Affiliated Hospital of Zhejiang University
Recruiting Phase 1 June 1, 2025
Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial
NCT06992128 Institute of Hematology & Blood Diseases Hospital, China
Recruiting Phase 2 May 22, 2025
A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
NCT06759636 The First Affiliated Hospital with Nanjing Medical University
Recruiting Phase 3 February 24, 2025
Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
NCT06693791 Anhui Provincial Hospital
Recruiting Phase 2 December 1, 2024
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
NCT06345495 M.D. Anderson Cancer Center
Recruiting Phase 2 October 1, 2024
Single Arm Romiplostim to Prevent CIT
NCT07048249 Children's Hospital Medical Center, Cincinnati
Recruiting Early phase 1 January 26, 2024
Thrombopoietin Agonists in Patients With Idiopathic Thrombocytopenic Purpura
NCT06137105 Assiut University
Not yet recruiting — December 1, 2023
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
NCT06497036 Geropharm
Active, not recruiting Phase 3 April 4, 2023
Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia
NCT05325593 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Active, not recruiting Phase 3 December 2, 2022
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
NCT04870346 Kyowa Kirin Co., Ltd.
Active, not recruiting — May 10, 2021
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
NCT03937154 Amgen
Active, not recruiting Phase 3 February 26, 2020
CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA
NCT07523009 Peking Union Medical College Hospital
Withdrawn Phase 2 Jun 2026
Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA
NCT07532408 Peking Union Medical College Hospital
Withdrawn Phase 2 Jun 2026
UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia
NCT07001254 Anjali Sharathkumar
Withdrawn Phase 2 April 10, 2025
Retrospective Study of Romiplostim for Platelet Engraftment After Allo-HSCT
NCT07747246 Tongji Hospital
Completed — January 1, 2025
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
NCT06686927 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Unknown status Phase 2 November 20, 2024
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
NCT06613880 Institute of Hematology & Blood Diseases Hospital, China
Unknown status Phase 2 October 24, 2024
Observational Study: Romiplostim for Platelet Recovery in Haploidentical HSCT
NCT07003256 Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
Completed — September 1, 2024
A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA
NCT06535685 Peking Union Medical College Hospital
Unknown status Phase 4 August 2, 2024
Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study
NCT06516484 Peking Union Medical College Hospital
Unknown status Phase 4 July 30, 2024
A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
NCT06440824 Shandong University
Unknown status Phase 3 June 1, 2024
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
NCT06658834 Institute of Hematology & Blood Diseases Hospital, China
Unknown status Phase 2 June 1, 2024
Romiplostim in Chemotherapy-Induced Thrombocytopenia
NCT06201663 Ain Shams University
Unknown status Phase 3 December 17, 2023
Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy
NCT05323617 Amgen
Withdrawn Phase 2 August 31, 2023
Romiplostim in Combination With CsA vs. CsA in the Treatment of Newly Diagnosed NSAA
NCT06009497 Peking Union Medical College Hospital
Unknown status Phase 4 Aug 2023
Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe
NCT06408324 European Research Consortium on ITP
Completed — November 24, 2022

All 123 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
15,126
Serious
11,653
With death outcome
2,668

Most reported reactions

  • Platelet count decreased 1,764
  • Drug ineffective 1,745
  • Off label use 1,250
  • Thrombocytopenia 1,013
  • Death 1,009
  • Platelet count abnormal 959
  • Therapeutic response decreased 944
  • Headache 606
  • Fatigue 473
  • Platelet count increased 402
  • Haemorrhage 393
  • Hospitalisation 391

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • Nplate HUMAN PRESCRIPTION DRUG Amgen, Inc June 23, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.