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A pivotal bioequivalence study and dosing optimization study (to remove the titration dose) of Pitolisant in patients with narcolepsy

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Trial Profile

A pivotal bioequivalence study and dosing optimization study (to remove the titration dose) of Pitolisant in patients with narcolepsy

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 01 Nov 2024

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Narcolepsy
  • Focus Therapeutic Use

    • Most Recent Events

    • 01 Nov 2024 New trial record
    • 29 Oct 2024 According to HARMONY BIOSCIENCES media release, company is on track to initiate pivotal bioequivalence study and dosing optimization study (to remove the titration dose) in Q1 2025.PDUFA on track for 2026 with IP to the mid-2040s

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