biostudies-literatureSinha JEunice Kennedy Shriver National Institute of Child Health and Human DevelopmentNICHD NIH HHS329-344https://www.ebi.ac.uk/biostudies/studies/S-EPMC12746435biostudies-literatureUnknown65(2)<h4>Background</h4>Oxcarbazepine (OXZ) is an antiepileptic drug whose pharmacological effect is primarily mediated by its active metabolite, 10-monohydroxy derivative (MHD). OXZ is approved for use in adults and children older than 2 years with an age- and body weight-tiered dosing recommendation, but dosing guidance for children with obesity is lacking.<h4>Objective</h4>This work aimed to assess the dosing requirements of OXZ in children with obesity to support label extension.<h4>Methods</h4>Two multicenter studies (NCT01431326 and NCT02993861) were conducted in patients receiving standard-of-care OXZ therapy. Participants ≥ 2 years of age with a body mass index ≥ 95th percentile were classified as obese. Plasma concentrations were measured by a validated liquid chromatography tandem masClinical pharmacokineticsPopulation Pharmacokinetic Modeling of Oxcarbazepine and Its Active Metabolite 10-Monohydroxy Derivative to Inform Dosing in Children with Obesity.PMC12746435R01 HD113201HHSN275201000003CR01 HD096435R01HD096435HHSN275201000003IR01 HD102949West LClark KMilleson CSimone GCraven STalbert JJohn RMourani PDix MTaylor LFearn LKennel PTaylor JJames LRiaz APohl DHornik CTuttle ABenoit MFinkelstein YEubanks SKowal KSims CFarrar CNielsen CGerhardt BGonzalez DOldham MWrenn SRathore MMottes TTaravath SKearns GLDesmarasis DLacaze TKlipner KHornik CDHastenson GHoward LMalone KLapid AHoward EOdero NAl-Uzri AHarper CGrzesek KKernen KRutebemberwa ARalston KYogev RPoff SAutmizguine JMassicotte CMyer DAnn DPShiloh-Malawsky YGreenberg RMahmoudi KTSKonow CMuller WJSwanson CKuchler AWiseheart MGreen TCapparelli EBradley GKirby CZimmerman KBalevic SJPaul IBaisden NO'Connor KGoldstein SDelmore PStubbs JVan KSinha JStryjewski GMuller WSierra YLakhotia AMichael ATraisman BWatt KKearns GSargent JMurchison BLaughon MPatubo KComings JZemek RMariconti ABeci RGoldenberg NChen LAnand RMeyer MWade KSroka PDeschenes JTerrell TSund ZMartinez MSteinbeiss MLitalien CChen JYJolly MBernhardt JOpel KBenjamin DKLeradi SDeGrauw TTaylor-Zapata PPaul IMBlanks TFilar LSullivan JArnold SArnold PAlderman CSimeon TBest Pharmaceuticals for Children Act–Pediatric Trials Network Steering CommitteeHarward MWalker ADrake ADePaoli BJoshi SHart MRumantir MPerry JBenjamin DBurmester JCermak JJoshi CPayne EHansberry DBorges ABrown KAnderson CDumitrascu MMcMilan HLague VLattimore SDiDomenico DfalsePopulation Pharmacokinetic Modeling of Oxcarbazepine and Its Active Metabolite 10-Monohydroxy Derivative to Inform Dosing in Children with Obesity.<h4>Background</h4>Oxcarbazepine (OXZ) is an antiepileptic drug whose pharmacological effect is primarily mediated by its active metabolite, 10-monohydroxy derivative (MHD). OXZ is approved for use in adults and children older than 2 years with an age- and body weight-tiered dosing recommendation, but dosing guidance for children with obesity is lacking.<h4>Objective</h4>This work aimed to assess the dosing requirements of OXZ in children with obesity to support label extension.<h4>Methods</h4>Two multicenter studies (NCT01431326 and NCT02993861) were conducted in patients receiving standard-of-care OXZ therapy. Participants ≥ 2 years of age with a body mass index ≥ 95th percentile were classified as obese. Plasma concentrations were measured by a validated liquid chromatography tandem mas2026-01-01T00:00:00Z2026 Feb2026-07-15T09:06:09.228Z2026-07-02T03:08:33.287ZS-EPMC127464354124743010.1007/s40262-025-01579-0