Last update 11 Dec 2024

Romiplostim biosimilar (Generium Pharmaceuticals)

Overview

Basic Info

Drug Type
Biosimilar, Fusion protein
Synonyms
GNR 069, GNR-069, GNR069
Target
TPO receptor
Mechanism
TPO receptor agonists(Thrombopoietin receptor agonists)
Therapeutic Areas
Immune System DiseasesHemic and Lymphatic Diseases
Active Indication
Purpura, Thrombocytopenic, Idiopathic
Inactive Indication-
Originator Organization
Generium ZAO
Active Organization
Generium ZAO
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Related

4
Clinical Trials associated with Romiplostim biosimilar (Generium Pharmaceuticals)
NCT05492409 / CompletedPhase 3
Extension Study of Long-term Safety and Immunogenicity of GNR-069 Patients With Idiopathic Thrombocytopenic Purpura Who Completed Phase 3 RMP-ITP-III Clinical Trial
NCT05220878 / CompletedPhase 3
Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
NCT04371939 / Unknown statusPhase 2IIT
Randomized, Two-arm Single-center Phase II Clinical Trial Comparing the Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome
100 Clinical Results associated with Romiplostim biosimilar (Generium Pharmaceuticals)
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100 Translational Medicine associated with Romiplostim biosimilar (Generium Pharmaceuticals)
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100 Patents (Medical) associated with Romiplostim biosimilar (Generium Pharmaceuticals)
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100 Deals associated with Romiplostim biosimilar (Generium Pharmaceuticals)
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Purpura, Thrombocytopenic, IdiopathicPhase 3
RU
Generium ZAO
09 Sep 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT00907478 (CTgov)
Phase 4
Purpura, Thrombocytopenic, Idiopathic
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01 Jan 2015
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Clinical Trial

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Approval

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Regulation

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