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Denali Therapeutics clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine and the EU Clinical Trials Information System (CTIS) — current trials in our USA, UK and EU (CTIS) registers with Denali Therapeutics as lead sponsor. Synced 26 Sep 2026
10Current trials
3Recruiting now
2Drugs in these trials
3Trial registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

Denali Therapeutics is the lead sponsor of 10 current clinical trials in our USA, UK and EU (CTIS) registers. 3 are recruiting patients now. The most common phase is Phase 1/2. The drugs named most often in its trials are Tividenofusp alfa and Idursulfase. The most-studied condition is Mucopolysaccharidosis II.

ClinicalTrials.gov trials by status

  • Recruiting333%
  • Active, closed556%
  • By invitation111%

Trials by phase

  • Phase 1/2333%
  • Phase 1333%
  • Phase 2/3222%
  • Phase 2111%
01

Clinical trials sponsored by Denali Therapeutics

9 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease
NCT07354724 · Late-onset Pompe Disease
Phase 1 Recruiting 2026-05 USA
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease
NCT07758595 · ClinicalTrials.gov ↗ · Alzheimer's Disease, Healthy Participants
Phase 1 Recruiting 2026-08 UK
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
NCT07328451 · ClinicalTrials.gov ↗ · Alzheimer Disease, Early Onset
Phase 1 Recruiting 2026-01 UK
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 · ClinicalTrials.gov ↗ · Mucopolysaccharidosis II
Phase 2/3 By invitation 2023-09 UK, USA
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
NCT06602193 · Parkinson Disease
Phase 2 Active, closed 2024-10 USA
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 2022-07 UK, USA
A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome
NCT04251026 · ClinicalTrials.gov ↗ · Mucopolysaccharidosis II
Phase 1/2 Active, closed 2020-07 UK, USA
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
NCT05262023 · ClinicalTrials.gov ↗ · Frontotemporal Dementia
Phase 1/2 Active, closed 2022-02 UK, USA
Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)
NCT06181136 · ClinicalTrials.gov ↗ · Mucopolysaccharidosis Type IIIA
Phase 1/2 Active, closed 2023-12 USA

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. Titles and statuses are copied from the registry as published.

02

Denali Therapeutics in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System with Denali Therapeutics as sponsor. Some are the same study as a ClinicalTrials.gov record above; the two registries share no common ID. Trials with a site in Ireland are listed first.

StudyPhaseStatusCountries
A Phase 1b/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants with Late-Onset Pompe Disease
2025-524082-25-00 · CTIS ↗ · Musculoskeletal Diseases
Phase 1 Ongoing Germany, Netherlands
03

Drugs in Denali Therapeutics trials

2 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

04

Conditions in Denali Therapeutics trials

8 conditions
Mucopolysaccharidosis II3Frontotemporal Dementia1Alzheimer's Disease1Healthy Participants1Alzheimer Disease, Early Onset1Parkinson Disease1Late-onset Pompe Disease1Mucopolysaccharidosis Type IIIA1
05

By trial register

RegisterTrialsRecruiting
Clinical trials in USA71
Clinical trials in UK62
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers.

06

Other sponsors in Mucopolysaccharidosis II

SponsorTrials
JCR Pharmaceuticals2

Sponsors with the most current trials registered for this condition.

07

Questions about Denali Therapeutics trials

How many clinical trials does Denali Therapeutics sponsor?

Denali Therapeutics is the lead sponsor of 9 current trials on ClinicalTrials.gov in our USA and UK registers, and 1 authorised or ongoing trial in the EU register (CTIS), as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Denali Therapeutics trials recruiting?

Yes. 3 of its 9 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Denali Therapeutics testing?

Its current trials name 2 drugs and biologicals as interventions. The most frequent are Tividenofusp alfa (3) and Idursulfase (1). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. 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 trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. 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 the registries data on this page was last retrieved on 26 Sep 2026.

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.