{"id":"nd0612","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dyskinesia"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Hallucinations"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ND0612 provides continuous subcutaneous delivery of levodopa (converted to dopamine) and carbidopa (a decarboxylase inhibitor that prevents peripheral conversion of levodopa) via a portable pump. This continuous delivery approach aims to reduce motor fluctuations and dyskinesia compared to oral dosing by maintaining more stable dopamine levels in the brain throughout the day.","oneSentence":"ND0612 is a subcutaneous infusion formulation of levodopa/carbidopa that continuously delivers dopamine precursor to the brain to treat motor symptoms of Parkinson's disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:50.737Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Parkinson's disease with motor fluctuations in patients not adequately controlled by oral levodopa therapy"}]},"trialDetails":[{"nctId":"NCT02726386","phase":"PHASE2","title":"A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"NeuroDerm Ltd.","startDate":"2016-05-04","conditions":"Parkinson's Disease","enrollment":214},{"nctId":"NCT04006210","phase":"PHASE3","title":"Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations","status":"ACTIVE_NOT_RECRUITING","sponsor":"NeuroDerm Ltd.","startDate":"2019-09-30","conditions":"Parkinson's Disease","enrollment":381},{"nctId":"NCT01725802","phase":"PHASE1","title":"A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2012-12-16","conditions":"Parkinson's Disease","enrollment":8},{"nctId":"NCT02096601","phase":"PHASE1","title":"A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2014-08-11","conditions":"Parkinson's Disease","enrollment":16},{"nctId":"NCT02604914","phase":"PHASE1","title":"A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2015-05-29","conditions":"Parkinson's Disease","enrollment":36},{"nctId":"NCT01486628","phase":"PHASE1","title":"Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2012-04-30","conditions":"Parkinson's Disease","enrollment":36},{"nctId":"NCT01883505","phase":"PHASE2","title":"A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2014-01-06","conditions":"Parkinson's Disease","enrollment":30},{"nctId":"NCT02577523","phase":"PHASE2","title":"A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease","status":"COMPLETED","sponsor":"NeuroDerm Ltd.","startDate":"2015-12-29","conditions":"Parkinson's Disease","enrollment":38},{"nctId":"NCT02782481","phase":"PHASE3","title":"A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations","status":"WITHDRAWN","sponsor":"NeuroDerm Ltd.","startDate":"2016-08","conditions":"Parkinson's Disease","enrollment":""},{"nctId":"NCT03462043","phase":"PHASE3","title":"A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension","status":"WITHDRAWN","sponsor":"NeuroDerm Ltd.","startDate":"2018-04-10","conditions":"Parkinson","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":17,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Levodopa/Carbidopa solution","(Levodopa-Carbidopa solution)","ND0612H"],"phase":"phase_3","status":"active","brandName":"ND0612","genericName":"ND0612","companyName":"NeuroDerm Ltd.","companyId":"neuroderm-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ND0612 is a subcutaneous infusion formulation of levodopa/carbidopa that continuously delivers dopamine precursor to the brain to treat motor symptoms of Parkinson's disease. Used for Parkinson's disease with motor fluctuations in patients not adequately controlled by oral levodopa therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}