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tividenofusp alfa

tividenofusp alfa: 3 clinical trials tracked.

tividenofusp alfa evidence translation

What we can confirm

3 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about tividenofusp alfa, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors
Clinical Trial Registry Records (3)

An Open-Label Extension to Investigate the Long-Term Safety, Tolerability, and Efficacy of DNL310 in Patients With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

NCT06075537Registry updated 2026-06-11·Phase 2/Phase 3·DNLI
Enrolling by invitation

Primary endpoint: Incidence and intensity of treatment-emergent adverse events (TEAEs)

Interventionalopen99 targetStarted 2023-09Completion 2027-0629 sites · Argentina, Belgium, Canada, Czechia…Denali Therapeutics Inc.

A Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II

NCT05371613Registry updated 2026-09-09·Phase 2/Phase 3·DNLI
Active, not recruiting

Primary endpoint: Ratio to baseline in cerebrospinal fluid (CSF) heparan sulfate (HS) concentration (Cohort A)

InterventionalRandomizeddouble65 enrolledStarted 2022-07Completion 2027-1230 sites · Argentina, Belgium, Brazil, Canada…Denali Therapeutics Inc.

A Phase 1/2, Multicenter, Open-Label Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL310 in Pediatric Participants With Hunter Syndrome

NCT04251026Registry updated 2025-08-07·Phase 2·DNLI
Active, not recruiting

Primary endpoint: Incidence and severity of treatment-emergent adverse events (TEAEs)

Interventionalopen47 targetStarted 2020-07Completion 2031-027 sites · Canada, Netherlands, United Kingdom, United StatesDenali Therapeutics Inc.