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Trial Profile

Phase III study of milsaperidone for major depressive disorder (MDD)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 13 Nov 2024

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At a glance

Drugs VHX-896 (Primary)
Indications Major depressive disorder
Focus Therapeutic Use

Most Recent Events

13 Nov 2024 New trial record
06 Nov 2024 According to a Vanda Pharmaceuticals media release, company expects to submit a New Drug Application (NDA) for milsaperidone, the activemetabolite of Fanapt, for the treatments of schizophrenia and acute bipolar I disorder to the U.S. Food and Drug Administration (FDA) in early 2025.
06 Nov 2024 According to a Vanda Pharmaceuticals media release, company expects to initiate a Phase III program for milsaperidone by the end of 2024.

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