{"id":"dnl343","safety":{"commonSideEffects":[{"rate":null,"effect":"Unknown — Phase 2 data limited in public domain"}]},"_chembl":{"chemblId":"CHEMBL5569312","moleculeType":"Small molecule","molecularWeight":"457.84"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"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.","oneSentence":"DNL343 is a small-molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) that reduces pathological protein aggregation in neurodegeneration.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:10:59.231Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Parkinson's disease (LRRK2-associated and idiopathic)"}]},"trialDetails":[{"nctId":"NCT04297683","phase":"PHASE2, PHASE3","title":"HEALEY ALS Platform Trial - Master Protocol","status":"RECRUITING","sponsor":"Merit E. Cudkowicz, MD","startDate":"2020-06-14","conditions":"Amyotrophic Lateral Sclerosis","enrollment":1500},{"nctId":"NCT05842941","phase":"PHASE2, PHASE3","title":"HEALEY ALS Platform Trial - Regimen G DNL343","status":"COMPLETED","sponsor":"Merit E. Cudkowicz, MD","startDate":"2023-05-24","conditions":"Amyotrophic Lateral Sclerosis","enrollment":249},{"nctId":"NCT05006352","phase":"PHASE1","title":"A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis","status":"COMPLETED","sponsor":"Denali Therapeutics Inc.","startDate":"2021-08-11","conditions":"Amyotrophic Lateral Sclerosis","enrollment":29},{"nctId":"NCT06281158","phase":"PHASE1","title":"A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants","status":"COMPLETED","sponsor":"Denali Therapeutics Inc.","startDate":"2024-03-01","conditions":"Healthy Volunteers","enrollment":7},{"nctId":"NCT04268784","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers","status":"COMPLETED","sponsor":"Denali Therapeutics Inc.","startDate":"2020-02-20","conditions":"Healthy Volunteers","enrollment":96},{"nctId":"NCT04581772","phase":"PHASE1","title":"A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers","status":"COMPLETED","sponsor":"Denali Therapeutics Inc.","startDate":"2020-12-23","conditions":"Healthy Volunteers","enrollment":31}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"DNL343","genericName":"DNL343","companyName":"Denali Therapeutics Inc.","companyId":"denali-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}