DNL343

Phase 1Small molecule

DDenali Therapeutics Inc.

DNL343 is one of 39 small molecule programs targeting Amyotrophic Lateral Sclerosis. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Amyotrophic Lateral SclerosisCompleted

Amyotrophic Lateral SclerosisPhase 1

Completed

Competition

Competitive Landscape

55 competitors in Amyotrophic Lateral Sclerosis

#DrugCompanyPhaseTrials

Vimpat

UCB

Approved

—2

Nourianz

Kyowa Kirin Co., Ltd.

Enablex

Bosulif

PPrism Pharmaceuticals

Approved

1 5

Qalsody

Biogen

Approved

3 6

Avodart

Akero Therapeutics

Approved

—7

Quinidine Gluconate

WWyeth-Lederle Vaccines

Mirapex

Transderm Scop

BBaxter Healthcare Corporation

Approved

—10

Rocephin

CConrado Roberto Hoffmann Filho

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

PreclinicalActive, not recruiting

Amyotrophic Lateral Sclerosis

NCT04297683

Clinical

Trials by Indication[1]

Amyotrophic Lateral Sclerosis2 trials

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

Completed·DDenali Therapeutics Inc.·Phase 1·NCT05006352·29 enrolled

HEALEY ALS Platform Trial

Active, not recruiting·MMerit E. Cudkowicz, MD·Preclinical·NCT04297683·1,500 enrolled

Trial1 trial

HEALEY ALS Platform Trial - Regimen G DNL343

Completed·MMerit E. Cudkowicz, MD·Phase 2/3·NCT05842941·249 enrolled

Tics1 trial

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

Completed·DDenali Therapeutics Inc.·Phase 1·NCT04268784·96 enrolled

Unspecified1 trial

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

Completed·DDenali Therapeutics Inc.·Phase 1·NCT04581772·31 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for DNL343. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — DNL343 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for DNL343. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Denali Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: DDenali Therapeutics Inc.

DNL343

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Amyotrophic Lateral Sclerosis2 trials

Trial1 trial

Tics1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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