{"id":"focalin-xr","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Insomnia"},{"rate":"10-15","effect":"Decreased appetite"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Nervousness"},{"rate":"5-10","effect":"Abdominal pain"},{"rate":"5","effect":"Tachycardia"},{"rate":"5","effect":"Increased blood pressure"}]},"_chembl":{"chemblId":"CHEMBL258896","moleculeType":"Small molecule","molecularWeight":"549.67"},"_dailymed":{"setId":"9cf76f62-48aa-4065-94fd-6fc910391ab5","title":"FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dexmethylphenidate is the active d-isomer of methylphenidate, a central nervous system stimulant. It works by inhibiting the reuptake of dopamine and norepinephrine, thereby increasing their concentration in the synaptic cleft and enhancing neurotransmission in brain regions responsible for attention and impulse control. The XR formulation provides sustained release over approximately 12 hours.","oneSentence":"Focalin XR is an extended-release formulation of dexmethylphenidate that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the presynaptic neuron.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:13:09.865Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention-deficit/hyperactivity disorder (ADHD) in children and adults"}]},"trialDetails":[{"nctId":"NCT07300956","phase":"PHASE4","title":"Treating Young Children With Attention Deficit Hyperactivity Disorder","status":"NOT_YET_RECRUITING","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2026-02","conditions":"Attention-Deficit/Hyperactivity Disorder (ADHD)","enrollment":370},{"nctId":"NCT05916339","phase":"PHASE4","title":"AWARE: Management of ADHD in Autism Spectrum Disorder","status":"RECRUITING","sponsor":"Daniel Coury","startDate":"2023-10-01","conditions":"ADHD, Autism Spectrum Disorder","enrollment":500},{"nctId":"NCT03420339","phase":"PHASE4","title":"Stimulant Effects on Disruptive Behavior","status":"RECRUITING","sponsor":"Matthew J O'Brien, PhD, BCBA-D","startDate":"2018-10-01","conditions":"Attention Deficit Hyperactivity Disorder, Problem Behavior","enrollment":10},{"nctId":"NCT00829673","phase":"PHASE1","title":"Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2004-06","conditions":"Healthy","enrollment":24},{"nctId":"NCT00829712","phase":"PHASE1","title":"Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2004-06","conditions":"Healthy","enrollment":24},{"nctId":"NCT04577417","phase":"","title":"Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD","status":"COMPLETED","sponsor":"Nemours Children's Clinic","startDate":"2020-09-13","conditions":"Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity","enrollment":70},{"nctId":"NCT00429273","phase":"PHASE4","title":"Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2007-01","conditions":"Attention Deficit Disorder With Hyperactivity","enrollment":212},{"nctId":"NCT04138498","phase":"PHASE1, PHASE2","title":"CTx-1301 Comparative Bioavailability Study","status":"COMPLETED","sponsor":"Cingulate Therapeutics","startDate":"2019-12-06","conditions":"ADHD","enrollment":45},{"nctId":"NCT01399827","phase":"PHASE2","title":"Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2012-02","conditions":"Attention Deficit Hyperactivity Disorder (ADHD), Deficient Emotional Self-Regulation (DESR)","enrollment":2},{"nctId":"NCT02204410","phase":"PHASE4","title":"Omega-3 Supplementation to ADHD Medication in Children","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2014-07","conditions":"Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation","enrollment":21},{"nctId":"NCT00393042","phase":"PHASE3","title":"Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR","status":"COMPLETED","sponsor":"Seattle Children's Hospital","startDate":"2006-01","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":77},{"nctId":"NCT01951508","phase":"EARLY_PHASE1","title":"Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2013-10","conditions":"Healthy, Substance-related Disorder, Mood Disorder","enrollment":24},{"nctId":"NCT00593138","phase":"PHASE1, PHASE2","title":"Study of Dopamine Transporter Receptor Occupancy With Long-acting Dex-methylphenidate","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2006-12","conditions":"Drug Binding to DAT Receptors","enrollment":23},{"nctId":"NCT00564954","phase":"PHASE4","title":"A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-10","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":86},{"nctId":"NCT00776009","phase":"PHASE4","title":"Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-10","conditions":"Attention-Deficit/Hyperactivity Disorder (ADHD)","enrollment":165},{"nctId":"NCT00361387","phase":"PHASE4","title":"Use of Focalin for Fatigue in Sarcoidosis","status":"COMPLETED","sponsor":"University of Cincinnati","startDate":"2006-06","conditions":"Sarcoidosis","enrollment":12},{"nctId":"NCT00141063","phase":"PHASE3","title":"Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-06","conditions":"ADHD","enrollment":90},{"nctId":"NCT00141050","phase":"PHASE3","title":"Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-05","conditions":"ADHD","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20210626","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20250923","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20190110","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20150612","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20231013","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20190110","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20170104","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20130611","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20100504","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20151204","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20101115","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20070425","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20231013","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20060801","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20191119","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20060411","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20150417","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20060801","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20131212","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20060411","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20120502","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20091023","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20110421","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20091023","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20050526","type":"ORIG","sponsor":"SANDOZ","applicationNumber":"NDA021802"},{"date":"20081017","type":"SUPPL","sponsor":"SANDOZ","applicationNumber":"NDA021802"}],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Focalin XR","genericName":"Focalin XR","companyName":"Novartis","companyId":"novartis","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Focalin XR is an extended-release formulation of dexmethylphenidate that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the presynaptic neuron. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}