tividenofusp alfa

DRUG3 trials

Sponsors

Denali Therapeutics Inc.

Conditions

Mucopolysaccharidosis II

Phase 1

A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

Active, not recruitingNCT04251026

Denali Therapeutics Inc.Mucopolysaccharidosis II

Start: 2020-07-16End: 2031-02-28Updated: 2025-08-07

Phase 2

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)

Active, not recruitingNCT05371613

Denali Therapeutics Inc.Mucopolysaccharidosis II

Start: 2022-07-21End: 2027-12-01Updated: 2026-09-09

An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

Enrolling by invitationNCT06075537

Denali Therapeutics Inc.Mucopolysaccharidosis II

Start: 2023-09-20End: 2027-06-01Target: 99Updated: 2026-06-11

Related Papers

An Intravenous Brain-Penetrant Enzyme Therapy for Mucopolysaccharidosis II.

2026-01-01