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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

Tividenofusp Alfa

Company
Denali Therapeutics Inc.
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
None currently listed

Efficacy results: Not yet reported

No recruiting studies currently listed

See all studies for this drug

Data source: ClinicalTrials.gov · trial data as of Oct 28, 2026

Trial details
  • Active, not recruiting NCT NCT04251026

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

    Not yet reported, Not yet reported Denali Therapeutics Inc. 47 participants Est. completion 2031-02 7 sites Stand-alone
    Other conditions: Mucopolysaccharidosis II
    View official trial listing →
  • Active, not recruiting NCT NCT05371613

    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)

    Not yet reported, Not yet reported Denali Therapeutics Inc. 65 participants Est. completion 2027-12 30 sites Stand-alone
    Other conditions: Mucopolysaccharidosis II
    View official trial listing →
  • Enrolling by invitation NCT NCT06075537

    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

    Not yet reported, Not yet reported Denali Therapeutics Inc. 99 participants Est. completion 2027-06 30 sites Stand-alone
    Other conditions: Mucopolysaccharidosis II
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: Tividenofusp Alfa, AVLAYAH

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.