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HBS-201

Development stage: Phase 1
Lead developer: Harmony Biosciences
Modality: Small Molecules
Administration: Oral

Overview

**HBS-201** is a delayed-release formulation of pitolisant, a selective histamine H3 receptor antagonist/inverse agonist designed to enhance wakefulness by increasing histamine release and downstream neurotransmitters like dopamine, noradrenaline, and acetylcholine. Developed for narcolepsy treatment, it allows initiation at therapeutic doses (17.8-35.6 mg), mirroring the FDA-approved Wakix (pitolisant) dosing, and is currently under evaluation in a Phase 1b tolerability study (NCT07051252) in adults with narcolepsy.[1][3]

Other names: Pitolisant Delayed-release

Targets

HRH3 (Histamine Receptor H3)

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