Last update 08 May 2025

SHP-631

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
HIRMAB-IDS, IgG iduronate 2 sulfatase fusion protein
+ [4]
Target
IDS
Action
modulators
Mechanism
IDS modulators(Iduronate-2-sulfatase modulators)
Therapeutic Areas
Nervous System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]
Active Indication
Mucopolysaccharidosis II
Inactive Indication-
Originator Organization
ArmaGen, Inc.ArmaGen, Inc.
Active Organization
Shire Pharmaceuticals Services Ltd.
Inactive Organization
ArmaGen, Inc.ArmaGen, Inc.
License Organization
ArmaGen, Inc.ArmaGen, Inc.Shire Pharmaceuticals LLC
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Related

1
Clinical Trials associated with SHP-631
NCT02262338
/ CompletedPhase 1
A Phase 1 Safety and Dose-Finding Study of a Human Insulin Receptor Monoclonal Antibody-Human Iduronate 2-Sulfatase (IDS) Fusion Protein, AGT-182 in Adult Patients With Mucopolysaccharidosis II (MPS II, Hunter Syndrome)
100 Clinical Results associated with SHP-631
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100 Translational Medicine associated with SHP-631
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100 Patents (Medical) associated with SHP-631
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100 Deals associated with SHP-631
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Mucopolysaccharidosis IIPhase 2-
Shire Pharmaceuticals Services Ltd.
-
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Clinical Result

Indication
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Clinical Trial

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Approval

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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