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Priya Life Science Compound trial record
Compound · clinical trials

Tividenofusp alfa clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 3 trials in our UK, USA, Netherlands, Canada, Germany, France, Spain, Italy, Belgium, Sweden, Czechia, Turkey and Brazil registers that name Tividenofusp alfa as an intervention. Synced 8 Nov 2026
3Current trials
0Recruiting now
1Lead sponsor
13Country registers
At a glance

Tividenofusp alfa is named as an intervention in 3 current clinical trials in our UK, USA, Netherlands, Canada, Germany, France, Spain, Italy, Belgium, Sweden, Czechia, Turkey and Brazil registers. None are recruiting at the moment. The most common phase is Phase 2/3. The lead sponsor is Denali Therapeutics Inc. The most-studied condition is Mucopolysaccharidosis II.

Where Tividenofusp alfa is approved

All regulators →

Of the three regulators tracked here, the first to approve Tividenofusp alfa was the US, on 24 Mar 2026.

USUnited States (FDA)
24 Mar 2026
Avlayah
BLA761485 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

How Tividenofusp alfa works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Mucopolysaccharidosis type 2Phase 2/3

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594537, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Tividenofusp alfa

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Active, closed267%
  • By invitation133%

Trials by phase

  • Phase 2/3267%
  • Phase 1/2133%
01

Clinical trials of Tividenofusp alfa

3 trials
StudyPhaseStatusLead sponsorRegisters
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
NCT06075537 · Mucopolysaccharidosis II
Phase 2/3 By invitation Denali Therapeutics Inc UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Czechia, Turkey, Canada, Brazil
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)
NCT05371613 · Mucopolysaccharidosis II
Phase 2/3 Active, closed Denali Therapeutics Inc UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Sweden, Czechia, Turkey, Canada, Brazil
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
NCT04251026 · Mucopolysaccharidosis II
Phase 1/2 Active, closed Denali Therapeutics Inc UK, USA, Netherlands, Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Tividenofusp alfa

1 condition
Mucopolysaccharidosis II3
05

Related compounds

06

Questions about Tividenofusp alfa trials

How many clinical trials are testing Tividenofusp alfa?

3 current trials in our UK, USA, Netherlands, Canada, Germany, France, Spain, Italy, Belgium, Sweden, Czechia, Turkey and Brazil registers name Tividenofusp alfa as a drug or biological intervention, as of the registry sync on 8 November 2026. Completed and withdrawn studies are not counted.

Are Tividenofusp alfa trials recruiting patients?

Not at the moment. None of the 3 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.

Who sponsors Tividenofusp alfa clinical trials?

The lead sponsor is Denali Therapeutics Inc. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tividenofusp alfa works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tividenofusp alfa works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tividenofusp alfa (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 8 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.