ArticleClinical drug investigation2026
Effect of Hepatic Impairment on the Pharmacokinetics of Single-Dose Viloxazine Extended-Release Capsules (Qelbree
Article in Clinical drug investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
objectivesViloxazine (extended-release [ER] capsules) is a nonstimulant medication approved for the treatment of pediatric (aged ≥ 6 years) and adult attention deficit hyperactivity disorder. This study assessed the effect of hepatic impairment (HI) on the pharmacokinetics, safety, and tolerability of viloxazine ER.
methodsIn this open-label, multicenter study, adults (18-78 years) with mild (n = 8), moderate (n = 8), or severe (n = 8) HI (Child-Pugh classification) and a demographically matched control cohort with normal hepatic function received a single oral dose of viloxazine ER (200 or 400 mg), following a ≥ 10-h overnight fast. Blood samples were collected for 72 h post-administration and analyzed for viloxazine and its primary metabolite 5-hydroxy-viloxazine glucuronide. The potential for HI to impact pharmacokinetics was evaluated using relative bioavailability analysis of viloxazine maximum measured plasma concentration (C
resultsIn adults with versus without HI (any severity), there were no significant differences in viloxazine C
conclusionsMild-to-severe HI showed minimal impact on viloxazine ER exposure. The single dose of viloxazine ER was well-tolerated with no identified safety concerns.
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