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Nplate

(Romiplostim)

Phase 3Protein / enzyme

Romiplostim is used to treat low platelet counts (blood cells that help with clotting) in patients with immune thrombocytopenia, a condition where the immune system destroys platelets and increases bleeding risk.[1] Nplate is currently being investigated across 9 indications[3], with its most advanced program in Phase 3.[1]

Nplate is one of 192 biologic programs targeting Hemorrhage. It is currently in Phase 3.

9

Indications

57

Total Trials

10

Active Trials

191

Competitors

Pipeline

Status by Indication[3][1]

Indication

HemorrhageUnknown

Autoimmune Thrombocytopenic PurpuraUnknown

Chirurgical InterventionRecruiting

LymphomaActive, not recruiting

Severe Aplastic AnemiaNot yet recruiting

Non-Small Cell Lung CancerActive, not recruiting

RefractoryNot yet recruiting

MDSNot yet recruiting

Aplastic AnaemiaNot yet recruiting

HemorrhagePreclinical

Unknown

Autoimmune Thrombocytopenic PurpuraPreclinical

Unknown

Chirurgical InterventionPhase 2

Recruiting

LymphomaPhase 2

Active, not recruiting

Severe Aplastic AnemiaPhase 2

Not yet recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

RefractoryPhase 3

Not yet recruiting

MDSPhase 2

Not yet recruiting

Aplastic AnaemiaPhase 3

Not yet recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Nplate

Enlonstobart

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Sigvotatug Vedotin

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Valemetostat Tosylate

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

PD-1 Inhibitors

BBioNTech US Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Lymphoma

NCT04673266

Q2 2027

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT03937154

Q1 2028

Phase 1Recruiting

Study completion

NCT07048249

Q4 2028

Phase 2Recruiting

Chirurgical Intervention

NCT07278661

Phase 2Not yet recruiting

MDS

NCT07400341

Clinical

Trials by Indication[1]

Thrombocytopenia9 trials

Romiplostim in Chemotherapy-Induced Thrombocytopenia

Unknown status·—·Phase 3·NCT06201663·30 enrolled

Prevention of Thrombocytopenia in Glioblastoma Patients

Terminated·UUniversity Hospital, Lille·Phase 2·NCT02227576·20 enrolled

A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura

Completed· Amgen logo

Amgen·Phase 3·NCT01071954·66 enrolled

Show 6 more trials

Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04933942

Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

Terminated·UUniversity of Southern California·Phase 2·NCT01153919·27 enrolled

Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia

Completed·AAndres J. M. Ferreri·Phase 2·NCT01516619·3 enrolled

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.

Withdrawn· Amgen logo

Amgen·Phase 3·NCT03343847

Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02052882·60 enrolled

Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 1/2·NCT01980030·24 enrolled

Immune Thrombocytopenia8 trials

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

Completed· Amgen logo

Amgen·Phase 2·NCT01143038·75 enrolled

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients

Completed· Amgen logo

Amgen·Phase 3·NCT01444417·62 enrolled

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Completed· Amgen logo

Amgen·Phase 3·NCT02279173·203 enrolled

Show 5 more trials

Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Completed·KKyowa Kirin China Pharmaceutical Co., Ltd.·Phase 1/2·NCT02868060·16 enrolled

Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)

Completed· Amgen logo

Amgen·Phase 4·NCT00907478·169 enrolled

Immune Thrombocytopenia Management in Adults

Unknown status·NNahda University·Phase 4·NCT05861297·467 enrolled

Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

Unknown status·DDavid Gomez Almaguer·Phase 2·NCT04588194·12 enrolled

Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)

Completed·KKyowa Kirin China Pharmaceutical Co., Ltd.·Phase 3·NCT02868099·203 enrolled

Thrombocytopenic Purpura6 trials

Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim

Completed· GSK logo

GSK··NCT01439321·280 enrolled

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Completed· Amgen logo

Amgen·Phase 3·NCT00116688·313 enrolled

Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

Completed· Amgen logo

Amgen·Phase 3·NCT00415532·234 enrolled

Show 3 more trials

Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Completed· Amgen logo

Amgen·Phase 1/2·NCT00117143·16 enrolled

Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

Completed· Amgen logo

Amgen·Phase 2·NCT00111475·45 enrolled

Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)

Completed·WWeill Medical College of Cornell University·Phase 2·NCT00902018·20 enrolled

Aplastic Anemia3 trials

Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2/3·NCT02773290·46 enrolled

Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2/3·NCT04095936·24 enrolled

Study of AMG531(Romiplostim) in Patients With Aplastic Anemia

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2/3·NCT03957694·17 enrolled

Refractory2 trials

Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy

Withdrawn· Amgen logo

Amgen·Phase 2·NCT05323617

A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA

Not yet recruiting·PPeking Union Medical College Hospital·Phase 4·NCT06535685·40 enrolled

25 more indications

Wiskott-Aldrich syndrome2 trials

Romiplostim Treatment for Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome.

Completed·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology··NCT04350164·67 enrolled

Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2·NCT04371939·30 enrolled

Non-Small Cell Lung Cancer2 trials

Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

Completed· Amgen logo

Amgen·Phase 2·NCT00413283·63 enrolled

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT03937154·145 enrolled

Myelodysplastic Syndromes2 trials

Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)

Completed· Amgen logo

Amgen·Phase 2·NCT00303472·72 enrolled

Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

Completed· Amgen logo

Amgen·N/A·NCT00472290·72 enrolled

Immunomodulation1 trial

Immunomodulation With Romiplostim in Young Adults With ITP

Completed·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT02760251·15 enrolled

Ovarian Cancer1 trial

Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines

Terminated·GGesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH·Phase 2·NCT03622931·21 enrolled

Hematopoietic Cell Transplantation1 trial

Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04478123·62 enrolled

Colorectal Cancer1 trial

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT03362177·165 enrolled

Children1 trial

TPO-Mimetic Use in Children for Hematopoietic Failure

Completed·AAnjali Sharathkumar·Phase 1·NCT04478227·15 enrolled

Observational Study1 trial

An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

Unknown status·SSamsung Medical Center·Phase 2·NCT02338414·20 enrolled

Myelodysplastic Syndrome1 trial

Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Completed· Amgen logo

Amgen·Phase 2·NCT00614523·250 enrolled

Lymphoma1 trial

Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04673266·11 enrolled

Severe Aplastic Anemia1 trial

UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia

Not yet recruiting·AAnjali Sharathkumar·Phase 2·NCT07001254·15 enrolled

MDS1 trial

Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT07400341·66 enrolled

Multiple Myeloma1 trial

Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy

Terminated·NNYU Langone Health·Phase 2·NCT01676961·5 enrolled

Newly Diagnosed1 trial

Romiplostim in Combination With CsA vs. CsA in the Treatment of Newly Diagnosed NSAA

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT06009497·44 enrolled

Aplastic Anaemia1 trial

Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study

Not yet recruiting·PPeking Union Medical College Hospital·Phase 4·NCT06516484·40 enrolled

MPA1 trial

Indirect Comparison Between Eltrombopag & Romiplostim

Completed· GSK logo

GSK··NCT01236014·1 enrolled

ITP1 trial

Safety Study of AMG 531 in Japanese Subjects With ITP

Completed· Kyowa Kirin Co., Ltd. logo

Kyowa Kirin Co., Ltd.·Phase 2·NCT00305435·12 enrolled

Adult1 trial

An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP

Completed· Amgen logo

Amgen·Phase 3·NCT00508820·407 enrolled

Chemotherapy1 trial

A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04671901·2 enrolled

Primary Immune Thrombocytopenia1 trial

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).

Recruiting· Amgen logo

Amgen·Phase 3·NCT07700238·126 enrolled

Splenomegaly1 trial

High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06345495·30 enrolled

Thalassemia in Children1 trial

An Observational Study on the Promotion of Platelet Recovery by Romiplostim During Haploidentical Hematopoietic Stem Cell Transplantation

Completed·HHaikou Affiliated Hospital of Central South University Xiangya School of Medicine··NCT07003256·16 enrolled

Chirurgical Intervention1 trial

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.

Recruiting·NNantes University Hospital·Phase 2·NCT07278661·136 enrolled

Unspecified2 trials

Safety of Romiplostim (Nplate®) Following UCBT

Completed·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT02046291·21 enrolled

Single Arm Romiplostim to Prevent CIT

Recruiting·—·Phase 1·NCT07048249·26 enrolled

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Romiplostim. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Romiplostim compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Romiplostim. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thrombopoietin Receptor Agonist[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Amgen

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