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A phase 3 trial of Pitolisant for the treatment of narcolepsy

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A phase 3 trial of Pitolisant for the treatment of narcolepsy

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2025

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Narcolepsy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Harmony Biosciences

    • Most Recent Events

    • 28 Feb 2025 New trial record
    • 25 Feb 2025 According to a Harmony Biosciences media release, Trial to initiate in Q4 2025; topline data readout anticipated in 2027 with potential PDUFA date in 2028.

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