Trial Profile

A Phase 3 registrational trial, a double-blind, randomized, parallel-group study in patients with idiopathic hypersomnia

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 28 Feb 2025

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At a glance

25 Feb 2025 According to the Harmony Biosciences Media Release, topline data readout anticipated in 2027.
24 Feb 2025 Company plans Phase 3 registrational trial, a double-blind, randomized, parallel-group study in patients with IH, is based on input from the FDA.
19 Feb 2025 According to the Harmony Biosciences Media Release, company is on track to initiate a Phase 3 registrational trial of Pitolisant HD in IH in Q4 2025, with a target PDUFA date in 2028.

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