Last update 29 Nov 2024

GNR-055

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
verenafusp alfa, GNR 055, GNR055
Target
IDS
Mechanism
IDS stimulators(Iduronate 2-sulfatase stimulators)
Therapeutic Areas
Nervous System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]
Active Indication
Mucopolysaccharidosis II
Inactive Indication-
Originator Organization
Generium ZAO
Active Organization
Generium ZAO
Inactive Organization-
Drug Highest PhasePhase 2/3
First Approval Date-
Regulation-
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Related

3
Clinical Trials associated with GNR-055
NCT06475404 / CompletedPhase 1
Open-label Multi-cohort Study of the Tolerability, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers After a Single Intravenous Injection in Increasing Doses
NCT05208281 / RecruitingPhase 2/3
Multicenter, Open-Label, Multi-cohort Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Drug Product GNR 055 (JSC "GENERIUM", Russia) in Patients With Mucopolysaccharidosis Type II
NCT04539340 / CompletedPhase 1
An Open-label Multi-cohort Dose-escalation Study to Evaluate the Tolerance, Safety, and Pharmacokinetics of GNR-055 (GENERIUM JSC, Russia) in Healthy Volunteers With a Single Intravenous Administration
100 Clinical Results associated with GNR-055
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100 Translational Medicine associated with GNR-055
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100 Patents (Medical) associated with GNR-055
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100 Deals associated with GNR-055
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mucopolysaccharidosis IIPhase 3
RU
Generium ZAO
30 Nov 2021
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Clinical Result

Indication
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Approval

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Regulation

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