MedPath

Denali Therapeutics

🇺🇸United States
Ownership
-
Employees
445
Market Cap
-
Website
Introduction

Denali Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates for neurodegenerative diseases. Its product pipeline includes LRRK2, RIPK1, TREM2, and Tau. The company was founded by Ryan J. Watts, Marc Tessier-Lavigne, and Alexander Schuth on October 14, 2013 and is headquartered in San Francisco, CA.

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

Phase 2
Recruiting
Conditions
Parkinson Disease
Interventions
Drug: BIIB122 225 mg
Other: BIIB122-Matching Placebo
First Posted Date
2024-09-19
Last Posted Date
2025-05-11
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
50
Registration Number
NCT06602193
Locations
🇩🇪

University Hospital Tübingen, Tübingen, Germany

🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

Parkinson's Disease and Movement Disorders Center, Boca Raton, Florida, United States

and more 11 locations

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

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2024-02-28
Last Posted Date
2024-06-20
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
7
Registration Number
NCT06281158
Locations
🇺🇸

Clinical Site, Madison, Wisconsin, United States

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

Phase 1
Recruiting
Conditions
Mucopolysaccharidosis Type IIIA
Interventions
First Posted Date
2023-12-26
Last Posted Date
2025-05-14
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
26
Registration Number
NCT06181136
Locations
🇺🇸

University of Iowa Stead Family Children's Hospital, Iowa City, Iowa, United States

🇺🇸

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

🇺🇸

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

and more 1 locations

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

Phase 2
Conditions
Mucopolysaccharidosis II
Interventions
First Posted Date
2023-10-10
Last Posted Date
2025-04-13
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
99
Registration Number
NCT06075537
Locations
🇪🇸

Hospit U. Vall d'Hebron - PPDS, Barcelona, Spain

🇨🇦

McGill University Health Center, Montréal, Canada

🇺🇸

UNC Children's Research Institute, Chapel Hill, North Carolina, United States

and more 9 locations

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participant
Interventions
Drug: Placebo
First Posted Date
2022-07-08
Last Posted Date
2023-08-16
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
47
Registration Number
NCT05450549
Locations
🇳🇱

Centre for Human Drug Research (CHDR), Leiden, South Holland, Netherlands

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)

Phase 2
Recruiting
Conditions
Mucopolysaccharidosis II
Interventions
First Posted Date
2022-05-12
Last Posted Date
2025-05-08
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
54
Registration Number
NCT05371613
Locations
🇬🇧

Royal Free Hospital, London, United Kingdom

🇹🇷

Cukurova University Medical Faculty Balcali Hospital, Adana, Turkey

🇪🇸

Hospital Infantil Universitario Niño Jesus, Madrid, Spain

and more 30 locations

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

Phase 1
Recruiting
Conditions
Frontotemporal Dementia
Interventions
Drug: Placebo
First Posted Date
2022-03-02
Last Posted Date
2025-02-04
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
106
Registration Number
NCT05262023
Locations
🇺🇸

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇧🇪

University of Antwerp, Antwerp, Belgium

🇧🇪

UZ Leuven, Leuven, Belgium

and more 26 locations

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

Phase 1
Active, not recruiting
Conditions
Amyotrophic Lateral Sclerosis
Interventions
Drug: Placebo
First Posted Date
2021-08-16
Last Posted Date
2023-01-17
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
30
Registration Number
NCT05006352
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

Atrium Health Neurosciences Institute, Charlotte, North Carolina, United States

🇺🇸

PPD Orlando, Orlando, Florida, United States

and more 4 locations

A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2020-10-09
Last Posted Date
2021-06-11
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
31
Registration Number
NCT04581772
Locations
🇳🇿

Auckland Clinical Studies Ltd., Grafton, Auckland, New Zealand

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2020-09-22
Last Posted Date
2022-03-07
Lead Sponsor
Denali Therapeutics Inc.
Target Recruit Count
186
Registration Number
NCT04557800
Locations
🇳🇱

PRA Health Sciences, Van Swietenlaan, Groningen, Netherlands

🇳🇱

Centre for Human Drug Research, Leiden, South Holland, Netherlands

© Copyright 2025. All Rights Reserved by MedPath