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DNL343
DNL343 is a small-molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) that reduces pathological protein aggregation in neurodegeneration.
DNL343 is a small-molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) that reduces pathological protein aggregation in neurodegeneration. Used for Parkinson's disease (LRRK2-associated and idiopathic).
At a glance
| Generic name | DNL343 |
|---|---|
| Sponsor | Denali Therapeutics Inc. |
| Drug class | LRRK2 kinase inhibitor |
| Target | LRRK2 (leucine-rich repeat kinase 2) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 2 |
Mechanism of action
LRRK2 is a kinase implicated in Parkinson's disease and other neurodegenerative conditions through its role in protein misfolding and cellular dysfunction. By inhibiting LRRK2 activity, DNL343 aims to slow or prevent the accumulation of pathological proteins and preserve neuronal function. This approach targets a genetic risk factor for Parkinson's disease and related disorders.
Approved indications
- Parkinson's disease (LRRK2-associated and idiopathic)
Common side effects
- Unknown — Phase 2 data limited in public domain
Key clinical trials
- HEALEY ALS Platform Trial - Master Protocol (PHASE2, PHASE3)
- HEALEY ALS Platform Trial - Regimen G DNL343 (PHASE2, PHASE3)
- A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis (PHASE1)
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants (PHASE1)
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers (PHASE1)
- A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DNL343 CI brief — competitive landscape report
- DNL343 updates RSS · CI watch RSS
- Denali Therapeutics Inc. portfolio CI