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A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

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Trial Profile

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2025

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At a glance

  • Drugs Milsaperidone (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Vanda Pharmaceuticals

Most Recent Events

  • 29 Oct 2025 According to a Vanda Pharmaceuticals media release, NDA for bipolar I disorder and schizophrenia is under review by the FDA with a PDUFA target action date of February 21, 2026.
  • 05 May 2025 According to a Vanda Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application.
  • 31 Mar 2025 According to a Vanda Pharmaceuticals media release, the company announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia.

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