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A pivotal bioequivalence study of Roluperidone in healthy volunteers

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Trial Profile

A pivotal bioequivalence study of Roluperidone in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Mar 2022

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At a glance

  • Drugs Roluperidone (Primary)
  • Indications Schizophrenia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Minerva Neurosciences

    • Most Recent Events

    • 28 Feb 2022 Status changed from active, no longer recruiting to completed, according to a Minerva Neurosciences media release.
    • 03 Nov 2021 According to a Minerva Neurosciences media release, the USA Food and Drug Administration (FDA) has denied the company's request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy. The company has not changed its previously announced projected timeline for submission of the NDA in the first half of 2022.
    • 30 Sep 2021 According to a Minerva Neurosciences media release, the company has completed the enrollment in this study on July 26, 2021.

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