New Slow-Release pill for narcolepsy passes early safety check

NCT ID NCT07051252

Completed Symptom relief Sponsor: Harmony Biosciences Management, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new slow-release form of pitolisant (HBS-201) in 46 adults with narcolepsy. The goal was to see if starting at a full dose is tolerable. Participants took the drug for 14 days, and researchers tracked side effects and dropouts.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: pitolisant delayed-release (HBS-201)
What this could lead to: If successful, this could lead to a more convenient once-daily pill for managing narcolepsy symptoms like excessive daytime sleepiness.
What could go wrong: This is an early Phase 1b study focused on tolerability, not effectiveness. The small size (46 people) and short duration mean results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

narcolepsy narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NARCOLEPSY

Contacts and locations

Locations

Harmony Site 1

Cincinnati, Ohio, 45245, United States
Harmony Site 10

Denver, North Carolina, 28037, United States
Harmony Site 11

Troy, Michigan, 48085, United States
Harmony Site 12

North Charleston, South Carolina, 29406, United States
Harmony Site 13

Newton, Massachusetts, 02459, United States
Harmony Site 14

Brandon, Florida, 33511, United States
Harmony Site 15

Wyomissing, Pennsylvania, 19610, United States
Harmony Site 2

Huntersville, North Carolina, 28078, United States
Harmony Site 3

Austin, Texas, 78731, United States
Harmony Site 4

Miami, Florida, 33176, United States
Harmony Site 5

Columbia, South Carolina, 29201, United States
Harmony Site 6

Canton, Ohio, 44718, United States
Harmony Site 7

Morgantown, West Virginia, 26506, United States
Harmony Site 8

Atlanta, Georgia, 30328, United States
Harmony Site 9

San Ramon, California, 94583, United States

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