New Slow-Release pill for narcolepsy passes early safety check

NCT ID NCT07051252

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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