DNL343

DRUG5 trials

Sponsors

Denali Therapeutics Inc., Merit E. Cudkowicz, MD

Conditions

Amyotrophic Lateral SclerosisHealthy Volunteers

Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers

CompletedNCT04268784

Denali Therapeutics Inc.Healthy Volunteers

Start: 2020-02-20End: 2021-08-03Updated: 2022-02-07

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

CompletedNCT04581772

Denali Therapeutics Inc.Healthy Volunteers

Start: 2020-12-23End: 2021-06-04Updated: 2021-06-11

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

CompletedNCT05006352

Denali Therapeutics Inc.Amyotrophic Lateral Sclerosis

Start: 2021-08-11End: 2024-06-05Updated: 2024-09-19

Phase 2

HEALEY ALS Platform Trial - Master Protocol

RecruitingNCT04297683

Merit E. Cudkowicz, MDAmyotrophic Lateral Sclerosis

Start: 2020-06-14End: 2028-08-01Target: 1500Updated: 2026-03-27

HEALEY ALS Platform Trial - Regimen G DNL343

CompletedNCT05842941

Merit E. Cudkowicz, MDAmyotrophic Lateral Sclerosis

Start: 2023-05-24End: 2024-10-29Updated: 2026-01-28

Related Papers

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Efficacy and Safety of Zilucoplan in Amyotrophic Lateral Sclerosis

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Pridopidine in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.

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CNM-Au8 in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.

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Verdiperstat in Amyotrophic Lateral Sclerosis: Results From the Randomized HEALEY ALS Platform Trial.

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The Integrated Stress Response Is Modulated by eIF2B Agonist DNL343: Results From Phase 1 Healthy Subject and Phase 1b ALS Patient Studies. (P8-8.010)

Neurology2023-04-2510 citations

Results from the first four regimens of the HEALEY ALS Platform Trial (PL5.004)

Neurology2023-04-254 citations

Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease

BMJ Open2022-07-0134 citations