DNL343

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DNL343

Denali Therapeutics · ALS
Mid-stage completed completed CT.gov grounded

ALS program aimed at stress-response biology rather than gene-specific targeting.

Open ALS hub Filter main pipeline

Program overview

Mechanism
integrated stress response modulation
Modality
small molecule
Phase
Mid-stage
Status
completed
Recruitment
completed
Confidence
medium
Watch priority
2
Last verified
20 Apr 2026

Sponsor and trial identifiers

Sponsor
Denali Therapeutics
Trial IDs
NCT05842941, NCT05006352
ClinicalTrials.gov exact matches: NCT05842941, NCT05006352

Regions and recruitment

Active in 2 regions
United States Netherlands

Indication tags

ALS

Milestones and catalysts

Last milestone
One of the more visible ALS pipeline programs outside the approved genetic niche.
Next expected catalyst
Readouts on clinical progression and tolerability.

Related pages

Disease hub ALS hub Disease-specific views with programs, mechanisms, and related context.
Research Research agenda Research notes and background around ALS.
Key Targets Key targets The mechanisms and intervention levers behind these programs.
Discover Discover Explainers and visual introductions to the science behind neurodegeneration.
Join Get involved Contribute research, writing, design, engineering, or review.

Related programs

Each card explains why it is here so you can read the overlap at a glance.

Masitinib

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Priority 2
Late-stage active recruiting

Late-stage ALS program that stays relevant because the field still lacks enough credible shots on goal.

Shown because it shares same disease bench and same modality with DNL343.
Mechanism
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Modality
small molecule
Next catalyst
Phase 3 progression and whether the long-running controversy resolves into a usable signal.
Last verified
20 Apr 2026

Tofersen

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Priority 1
Approved / Post-approval completed completed

Gene-targeted ALS therapy with major strategic importance for precision neurodegeneration treatment.

Shown because it shares same disease bench and shared biology: als with DNL343.
Mechanism
SOD1 antisense reduction
Modality
ASO
Next catalyst
Longer-term follow-up and real-world use data.
Last verified
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MND-SMART

University of Edinburgh · ALS
Priority 2
Mid-stage / Late-stage active recruiting

A UK-centered ALS platform trial that matters as infrastructure as much as any single drug inside it.

Shown because it shares same disease bench and shared biology: als with DNL343.
Mechanism
multi-arm adaptive platform trial
Modality
platform / multi-intervention trial
Next catalyst
Ongoing arm-level readouts and additions within the adaptive platform framework.
Last verified
20 Apr 2026

NurOwn

BrainStorm Cell Therapeutics · ALS
Priority 2
Late-stage active not yet recruiting

A controversial but undeniably field-relevant ALS cell-therapy program that should be represented in a serious pipeline monitor.

Shown because it shares same disease bench and shared biology: als with DNL343.
Mechanism
autologous MSC-NTF cell therapy
Modality
cell therapy
Next catalyst
Whether the renewed Phase 3 path can produce a cleaner efficacy narrative than prior attempts.
Last verified
20 Apr 2026

Source links

ClinicalTrials.gov NCT05842941 ClinicalTrials.gov NCT05006352 ClinicalTrials.gov search Denali pipeline
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