Trial Profile

Clinical study of TPM-1116 for the treatment of Narcolepsy and other sleep-wake disorders.

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 29 Jun 2025

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At a glance

11 Jun 2025 According to Harmony Biosciences Media release, study is planned to begin in 2H 2025 with topline data anticipated in 2026. Additionally, an Investigational New Drug (IND) application for BP1.15205 will be filed with the U.S. Food and Drug Administration (FDA). An Investigational Medicinal Product Dossier (IMPD) application with the European Medicines Agency (EMA) is being completed for BP1.15205.
25 Feb 2025 According to Harmony Biosciences Media release, IMPD submission on track for mid-2025.
13 Jan 2025 According to Harmony Biosciences Media release, company is on track for BP1.15205 first-in-human study in Q3 2025.

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