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Viloxazine hydrochloride - Supernus Pharmaceuticals

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Drug Profile

Viloxazine hydrochloride - Supernus Pharmaceuticals

Alternative Names: QELBREE; SPN 809; SPN 812; SPN-812 ER; SPN-812V; Viloxazine extended-release - Supernus Pharmaceuticals; Viloxazine hydrochloride extended release - Supernus Pharmaceuticals

Latest Information Update: 18 Nov 2025

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At a glance

  • Originator Rune Healthcare Limited
  • Developer Supernus Pharmaceuticals
  • Class Antidepressants; Behavioural disorder therapies; Ethers; Morpholines; Small molecules
  • Mechanism of Action Adrenergic uptake inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Attention-deficit hyperactivity disorder
  • Discontinued Depressive disorders

Most Recent Events

  • 06 Nov 2025 Knight plans to submit its response for new drug application to Health Canada in 2026
  • 06 Nov 2025 Knight receives a notice of non-compliance (NON) from Health Canada for its New Drug Submission for Qelbree® for Attention-deficit hyperactivity disorder
  • 07 May 2024 M8 Pharmaceuticals in-licenses Viloxazine hydrochloride from Supernus to seek regulatory approval and commercialize in Latin America

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