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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 developer

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 Trials (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

NCT06075537·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

NCT05371613·Phase 3·DNLI
Recruiting

Primary endpoint: Percent change from baseline in cerebrospinal fluid (CSF) heparan sulfate (HS) concentration (Cohort A)

InterventionalRandomizeddouble63 targetStarted 2022-07Completion 2027-1232 sites · Argentina, Australia, Belgium, Brazil…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

NCT04251026·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.