Denali Therapeutics Inc.

Biotech

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Pipeline

Pipeline Snapshot

By Phase

7 drugs in development

Phase 32

Phase 21

Phase 12

Preclinical1

By Therapeutic Area

top 4

Metabolic & Endocrine

338%

Neurology

225%

Gastroenterology

113%

Rare Disease

113%

R&D Momentum

45/100

Pipeline Velocity

11/100

Trial Completion Rate

100/100

Pipeline Concentration

25/100

Pipeline Freshness

72/100

Strategic Signals

↗Active in Gastroenterology but thin pipeline — potential licensing opportunity

Activity

Recent Activity

Last 14 days

Jul 14, 2026

Active, not recruiting

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)

Jul 2, 2026

Recruiting

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

Earlier

Jun 30, 2026TrialA Phase 1, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease

Oct 24, 2024TrialSafety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Mar 1, 2024TrialA Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

Sep 20, 2023TrialAn 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

Jul 21, 2022TrialA 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)

Jul 14, 2022TrialA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

4 more events

Feb 1, 2022TrialA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

Aug 11, 2021TrialA Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

Dec 23, 2020TrialA Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

Jul 16, 2020TrialA Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome