ELAPRASE

(Idursulfase)

Phase 3Protein / enzyme

Takeda

ELAPRASE is one of 26 biologic programs targeting Mucopolysaccharidosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MucopolysaccharidosisActive, not recruiting

MucopolysaccharidosisPhase 3

Active, not recruiting

Competition

Competitive Landscape

34 competitors in Mucopolysaccharidosis

#DrugCompanyPhaseTrials

Rituxan

Roche

Approved

1 2

Trexall

Alnylam Pharmaceuticals

Approved

1 3

Neoral

Immunoglobulin

1 5

Imuran

LLegacy Health System

Approved

—6

BMN 333

BioMarin Pharmaceutical

Phase 3

5 7

ELAPRASE

Takeda

Approved

2 8

Humira

CCelltrion

Phase 2

1 9

Genotropin

ELAPRASE

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

Timeline

Expected Milestones

Q4 2027

Phase 3Active, not recruiting

Mucopolysaccharidosis

NCT04573023

Phase 2/3Recruiting

Mucopolysaccharidosis

NCT05371613

Clinical

Trials by Indication[1]

Mucopolysaccharidosis2 trials

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

Active, not recruiting·JJCR Pharmaceuticals Co., Ltd.·Phase 3·NCT04573023·86 enrolled

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Recruiting·DDenali Therapeutics Inc.·Phase 2/3·NCT05371613·63 enrolled

Hunter Syndrome2 trials

Study of Idursulfase-beta (GC1111) in Hunter Syndrome

Unknown status·GGreen Cross Corporation·Phase 2·NCT02663024·20 enrolled

Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy

Completed· Takeda logo

Takeda·Phase 4·NCT00607386·28 enrolled

Observational Study1 trial

An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients

Completed· Takeda logo

Takeda··NCT00882921·26 enrolled

Drug1 trial

A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723

Completed· GSK logo

GSK··NCT01602601·10 enrolled

Outcome1 trial

Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase

Completed· Takeda logo

Takeda·Phase 2/3·NCT00630747·94 enrolled

1 more indication

Central Nervous System1 trial

A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®

Completed· Takeda logo

Takeda·Phase 1/2·NCT00920647·16 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 24, 2006

ELAPRASE

BLA BLA125151

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Idursulfase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Idursulfase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Idursulfase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125151). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Takeda

ELAPRASE

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Mucopolysaccharidosis2 trials

Hunter Syndrome2 trials

Observational Study1 trial

Drug1 trial

Outcome1 trial

Central Nervous System1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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