{"id":"oradur-methylphenidate","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nervousness or anxiety"},{"rate":null,"effect":"Tachycardia"},{"rate":null,"effect":"Elevated blood pressure"}]},"_chembl":{"chemblId":"CHEMBL796","moleculeType":"Small molecule","molecularWeight":"233.31"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Methylphenidate blocks the reuptake transporters for dopamine and norepinephrine, increasing their synaptic concentrations and enhancing neurotransmission in the brain. The ORADUR formulation provides sustained drug release over an extended period, allowing for once-daily dosing and more stable therapeutic levels throughout the day. This mechanism improves attention, focus, and impulse control in patients with attention deficit hyperactivity disorder (ADHD).","oneSentence":"ORADUR-Methylphenidate is an extended-release formulation of methylphenidate that inhibits the reuptake of dopamine and norepinephrine in the central nervous system.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:41.306Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention deficit hyperactivity disorder (ADHD) in children and adults"}]},"trialDetails":[{"nctId":"NCT02704390","phase":"PHASE3","title":"Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD","status":"COMPLETED","sponsor":"Orient Pharma Co., Ltd.","startDate":"2016-01","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":64},{"nctId":"NCT02450890","phase":"PHASE3","title":"Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD","status":"COMPLETED","sponsor":"Orient Pharma Co., Ltd.","startDate":"2015-06","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":114}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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_3","status":"active","brandName":"ORADUR®-Methylphenidate","genericName":"ORADUR®-Methylphenidate","companyName":"Orient Pharma Co., Ltd.","companyId":"orient-pharma-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ORADUR-Methylphenidate is a small molecule that inhibits the sodium-dependent dopamine transporter, classified as a dopamine transporter inhibitor. It is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents, as demonstrated in clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}