Drug Profile

Milsaperidone - Vanda Pharmaceuticals

Alternative Names: Bysanti; BysantiTM; P-88; VHX 869; VHX-896

Latest Information Update: 30 Jul 2025

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At a glance

Originator Vanda Pharmaceuticals
Class Antipsychotics; Mood stabilisers
Mechanism of Action Dopamine D2 receptor antagonists; Serotonin 5-HT2 receptor antagonists

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

Preregistration Bipolar disorders; Schizophrenia
Phase III Major depressive disorder

Most Recent Events

05 May 2025 FDA assigns PDUFA action date of 21/02/2026 for Milsaperidone for Schizophrenia and Bipolar disorder
05 May 2025 Vanda Pharmaceuticals has patents pending for milsaperidone
05 May 2025 FDA assigns regulatory action date of 21/02/2026 for milsaperidone for Schizophrenia and Bipolar disorders

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