Denali Therapeutics

Open enrollment with an early-phase pipeline tilt

According to ClinicalTrials.gov-derived indexes, Denali Therapeutics sits in the top decile of US sponsors by registered trial count (#1,137 of 15,742 sponsors by registered trial count).

12 total trials 3 currently recruiting 6 completed early-phase tilt top decile by trial count

Denali Therapeutics: 12 sponsored US clinical trials, 3 recruiting.

Denali Therapeutics sponsors 12 registered US clinical trials on ClinicalTrials.gov, 3 of them currently recruiting, and 6 completed. 0 of these trials are in Phase 3-4 (later-stage) and 11 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Mucopolysaccharidosis II, with 2 trials.

Top-decile sponsor footprint

Denali Therapeutics ranks in the top decile of sponsors by registered trial count (#1,137 of 15,742 sponsors by registered trial count). Volume at this scale usually reflects a long institutional pipeline, read phase tilt and therapeutic areas below before treating it as current-year activity.

Open and recent trials

12 total, page 1 of 1

RECRUITING Phase 1

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease

NCT07354724
RECRUITING Phase 2

Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

NCT06602193
RECRUITING Phase 2

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
ACTIVE NOT RECRUITING Phase 1

Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)

NCT06181136
ACTIVE NOT RECRUITING Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

NCT05262023
ACTIVE NOT RECRUITING Phase 1

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

NCT04251026
COMPLETED Phase 1

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

NCT06281158
COMPLETED Phase 1

A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

NCT05006352
COMPLETED

A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome

NCT04007536
COMPLETED Phase 1

Study to Evaluate DNL747 in Subjects With Alzheimer's Disease

NCT03757325
COMPLETED Phase 1

Study to Evaluate DNL201 in Subjects With Parkinson's Disease

NCT03710707
COMPLETED Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers

NCT04551534

Phase Distribution

PhaseTrial count
Phase 1 9
Phase 2 2

Therapeutic Areas

Mucopolysaccharidosis II 2
Mucopolysaccharidosis Type IIIA 1
Frontotemporal Dementia 1
Parkinson Disease 1

What is open in the Denali Therapeutics pipeline

3 recruiting of 12 indexed (25% open); 6 completed (50%).

Phase mix: 0 late (III/IV) vs 11 early (I/II) (early-phase heavy).

Top condition: Mucopolysaccharidosis II (2 trials), 3 others listed.

How open-pipeline share is computed

Recruiting share is recruiting_count divided by trial_count for this sponsor in the public registry export. Status can change between pulls; treat the figure as a research-attention snapshot, not product availability.

Denali Therapeutics: open-pipeline peers nationwide

Peers matched on 12 registered trials and 25% open enrollment, not the therapeutic-area sidebar.

Denali Therapeutics sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot). 2×2 strategic matrix plotting 9 entities by Total trials (X) and Recruiting share (Y), with a crosshair dividing the plot into four quadrants. Higher volume & more openFocused & more openHigher volume, mostly closedSmaller & mostly closed 2468101214 0%10%20%30% Total trials Recruiting share Denali TherapeuticsAlachua Government ServicesAllergy TherapeuticsAmpio Pharmaceuticals.AngiodynamicsAB ScienceAbbott Point of CareAbdul Latif Jameel Poverty Action LabAccutar Biotechnology
Denali Therapeutics sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot).

Denali Therapeutics sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together.

Sponsors near 12 trials (± recruiting share)

Sponsors near 25% open enrollment (± trial volume)

Related

Read our methodology - how this data is sourced, computed, and verified.

What to do with this Denali Therapeutics page

12 registered trials is a research-attention snapshot, not an endorsement of Denali Therapeutics or any single study.

  • 3 of Denali Therapeutics's trials are currently recruiting, check each one's own eligibility criteria before contacting a site. Browse recruiting trials
  • Mucopolysaccharidosis II is the condition Denali Therapeutics studies most, compare against other sponsors active in the same condition before evaluating a specific study. See Mucopolysaccharidosis II trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Denali Therapeutics pipeline card: 12 registered trials from official public datasets.Report a data error.