{"id":"tolperisone-hydrochloride","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Drowsiness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Gastrointestinal disturbances"}]},"_chembl":{"chemblId":"CHEMBL1395150","moleculeType":"Small molecule","molecularWeight":"281.83"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tolperisone acts as a non-selective muscle relaxant with analgesic properties, primarily through depression of polysynaptic spinal reflexes and reduction of muscle hypertonicity. It is believed to work via multiple mechanisms including sodium channel blockade and modulation of monoaminergic neurotransmission, leading to decreased muscle stiffness and improved motor function in conditions characterized by spasticity.","oneSentence":"Tolperisone hydrochloride is a centrally acting muscle relaxant that reduces muscle tone and spasticity by modulating neural pathways in the spinal cord.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:39:13.195Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Muscle spasticity associated with neurological disorders"},{"name":"Post-stroke spasticity"},{"name":"Spinal cord injury-related spasticity"}]},"trialDetails":[{"nctId":"NCT05544656","phase":"PHASE3","title":"The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain \"BETA\"","status":"ACTIVE_NOT_RECRUITING","sponsor":"Semmelweis University","startDate":"2019-12-13","conditions":"Low Back Pain","enrollment":150},{"nctId":"NCT04671082","phase":"PHASE3","title":"Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm","status":"COMPLETED","sponsor":"Neurana Pharmaceuticals, Inc.","startDate":"2020-12-15","conditions":"Back Muscle Spasm, Back Pain, Back Strain","enrollment":1004},{"nctId":"NCT05223946","phase":"NA","title":"Treatment and Companion Diagnostics of Lower Back Pain Using SCENAR and Passive Medical Radiometry (MWR)","status":"COMPLETED","sponsor":"Kyrgyz State Medical Academy","startDate":"2020-09-01","conditions":"Low Back Pain, Recurrent","enrollment":55},{"nctId":"NCT04407377","phase":"PHASE1","title":"Effects of Tolperisone on Measures of Drowsiness and Cognitive Function","status":"COMPLETED","sponsor":"Neurana Pharmaceuticals, Inc.","startDate":"2020-06-20","conditions":"Healthy","enrollment":39},{"nctId":"NCT03353922","phase":"PHASE1","title":"Driving Simulation to Assess Non-Sedative Effects of Tolperisone","status":"COMPLETED","sponsor":"Neurana Pharmaceuticals, Inc.","startDate":"2017-07-31","conditions":"Driving Impaired","enrollment":35},{"nctId":"NCT04465266","phase":"PHASE1","title":"A Phase 1 PK Study of Tolperisone in Healthy Subjects","status":"COMPLETED","sponsor":"Neurana Pharmaceuticals, Inc.","startDate":"2020-07-28","conditions":"Healthy","enrollment":27},{"nctId":"NCT03802565","phase":"PHASE2","title":"Tolperisone in Acute Muscle Spasm of the Back","status":"COMPLETED","sponsor":"Neurana Pharmaceuticals, Inc.","startDate":"2019-02-01","conditions":"Back Pain, Acute Pain, Back Spasm Upper Back","enrollment":415},{"nctId":"NCT00532532","phase":"PHASE2","title":"Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis","status":"TERMINATED","sponsor":"Avigen","startDate":"2007-09","conditions":"Muscle Spasticity","enrollment":150},{"nctId":"NCT00531466","phase":"PHASE2","title":"Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury","status":"TERMINATED","sponsor":"Avigen","startDate":"2007-09","conditions":"Muscle Spasticity","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tolperisone","EV product code: PRD4558977, miderizone tablet, ATC:M03BX04"],"phase":"phase_3","status":"active","brandName":"Tolperisone Hydrochloride","genericName":"Tolperisone Hydrochloride","companyName":"Neurana Pharmaceuticals, Inc.","companyId":"neurana-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tolperisone hydrochloride is a centrally acting muscle relaxant that reduces muscle tone and spasticity by modulating neural pathways in the spinal cord. Used for Muscle spasticity associated with neurological disorders, Post-stroke spasticity, Spinal cord injury-related spasticity.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}