idursulfase

Phase 3

Denali Therapeutics Inc. (DNLI)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

2 competitors in Mucopolysaccharidosis II

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Drug Information

Target Indication

Mucopolysaccharidosis II

Clinical Trial

NCT05371613

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA1/8/2007

Elaprase

Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.

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Drug Science

Mechanism of action & safety profile

Developer

DNLI

Denali Therapeutics Inc.

Biological Products, (No Diagnostic Substances)•North America•NASDAQ

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