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A Phase 3 trial of KP1077 in idiopathic hypersomnia (IH)

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Trial Profile

A Phase 3 trial of KP1077 in idiopathic hypersomnia (IH)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2024

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At a glance

  • Drugs Serdexmethylphenidate (Primary)
  • Indications Idiopathic hypersomnia
  • Focus Registrational; Therapeutic Use
  • Sponsors Zevra Therapeutics

Most Recent Events

  • 26 Mar 2024 According to a Zevra Therapeutics media release, results from phase 2 trial provided key information for the design of a potentially pivotal efficacy trial, and the results of the secondary efficacy endpoints were supportive of initiating a Phase 3 trial of KP1077. The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design.
  • 02 Oct 2023 According to a Zevra Therapeutics media release, trial expected to be initiated by the end of 2024.
  • 03 May 2023 According to a Zevra Therapeutics media release, data from this study ave the potential to support the advancement of KP1077 into a pivotal Phase 3 study in IH, as well as provide support in determining whether to initiate a Phase 3 trial in narcolepsy.

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