Denali Therapeutics

12 total trials 3 currently recruiting 6 completed

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.

Trial Pipeline

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

What the Pipeline for Denali Therapeutics Shows

According to the ClinicalTrials.gov registry, Denali Therapeutics is linked to 12 US clinical trials across every stage of research activity. Of those, 3 studies are currently recruiting, about 25% of the sponsor's indexed portfolio, and 6 are already marked complete, representing roughly 50% of the total.

The phase mix for Denali Therapeutics reports 0 late-stage studies (Phase 3 and Phase 4 combined) and 11 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Denali Therapeutics is Mucopolysaccharidosis II with 2 linked trials, and 3 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.