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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: 04 Aug 2026

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At a glance

  • Originator Rune Healthcare Limited
  • Developer Knight Therapeutics; 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

  • 02 Jul 2026 Alvogen Korea plans a phase III trial for Attention-deficit hyperactivity disorder (In adolescents, In children) in South Korea (PO, Controlled release) in July 2026 (NCT07678827)
  • 07 May 2026 Regulatory submission withdrawn for Attention-deficit hyperactivity disorder in Canada (PO)
  • 07 May 2026 Knight Therapeutics announces intention to submit NDA to Health Canada for Attention-deficit hyperactivity disorder

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