{"id":"serdexmethylphenidate-dexmethylphenidate","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nervousness/anxiety"},{"rate":null,"effect":"Tachycardia"},{"rate":null,"effect":"Elevated blood pressure"}]},"_chembl":{"chemblId":"CHEMBL4298139","moleculeType":"Small molecule","molecularWeight":"535.98"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Serdexmethylphenidate itself is inactive and serves as a prodrug formulation designed to improve the pharmacokinetic profile of dexmethylphenidate. Once absorbed, it is converted to dexmethylphenidate, the active d-enantiomer of methylphenidate, which blocks dopamine and norepinephrine transporters (DAT and NET) in the brain, increasing synaptic concentrations of these neurotransmitters. This mechanism enhances attention, focus, and impulse control in patients with attention-deficit/hyperactivity disorder (ADHD).","oneSentence":"Serdexmethylphenidate is a prodrug that is metabolized to dexmethylphenidate, which inhibits the reuptake of dopamine and norepinephrine in the central nervous system.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:07:31.099Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Serdexmethylphenidate%2Fdexmethylphenidate","title":"Serdexmethylphenidate/dexmethylphenidate","extract":"Serdexmethylphenidate/dexmethylphenidate, sold under the brand name Azstarys, is a fixed-dose combination medication containing serdexmethylphenidate, a prodrug of dexmethylphenidate, and dexmethylphenidate, a d-threo enantiomer of racemic methylphenidate, which is used to treat attention deficit hyperactivity disorder (ADHD) in people aged six years and older."},"indications":{"approved":[{"name":"Attention-deficit/hyperactivity disorder (ADHD)"}]},"trialDetails":[{"nctId":"NCT05721235","phase":"PHASE4","title":"A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD","status":"COMPLETED","sponsor":"Corium, Inc.","startDate":"2023-06-02","conditions":"Attention Deficit/Hyperactivity Disorder","enrollment":123},{"nctId":"NCT06000501","phase":"PHASE4","title":"Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2023-11-13","conditions":"Adult Attention Deficit Hyperactivity Disorder","enrollment":29},{"nctId":"NCT05685732","phase":"PHASE4","title":"An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD","status":"COMPLETED","sponsor":"Corium, Inc.","startDate":"2023-03-22","conditions":"Attention Deficit/Hyperactivity Disorder","enrollment":246},{"nctId":"NCT05668754","phase":"PHASE2","title":"Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH","status":"COMPLETED","sponsor":"Zevra Therapeutics","startDate":"2022-12-28","conditions":"Idiopathic Hypersomnia","enrollment":50},{"nctId":"NCT06359899","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Ark Biopharmaceutical Co., Ltd.","startDate":"2024-05","conditions":"ADHD","enrollment":50},{"nctId":"NCT03460652","phase":"PHASE3","title":"KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD","status":"COMPLETED","sponsor":"Zevra Therapeutics","startDate":"2018-03-13","conditions":"ADHD","enrollment":282},{"nctId":"NCT03292952","phase":"PHASE3","title":"KP415 Classroom Study in Children (6-12 Years of Age) With ADHD","status":"COMPLETED","sponsor":"Zevra Therapeutics","startDate":"2017-12-20","conditions":"ADHD","enrollment":155}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Azstarys"],"phase":"marketed","status":"active","brandName":"Serdexmethylphenidate/dexmethylphenidate","genericName":"Serdexmethylphenidate/dexmethylphenidate","companyName":"NYU Langone Health","companyId":"nyu-langone-health","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Serdexmethylphenidate is a prodrug that is metabolized to dexmethylphenidate, which inhibits the reuptake of dopamine and norepinephrine in the central nervous system. Used for Attention-deficit/hyperactivity disorder (ADHD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}