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
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Harmony Site 1
Cincinnati, Ohio, 45245, United States
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Harmony Site 10
Denver, North Carolina, 28037, United States
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Harmony Site 11
Troy, Michigan, 48085, United States
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Harmony Site 12
North Charleston, South Carolina, 29406, United States
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Harmony Site 13
Newton, Massachusetts, 02459, United States
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Harmony Site 14
Brandon, Florida, 33511, United States
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Harmony Site 15
Wyomissing, Pennsylvania, 19610, United States
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Harmony Site 2
Huntersville, North Carolina, 28078, United States
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Harmony Site 3
Austin, Texas, 78731, United States
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Harmony Site 4
Miami, Florida, 33176, United States
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Harmony Site 5
Columbia, South Carolina, 29201, United States
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Harmony Site 6
Canton, Ohio, 44718, United States
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Harmony Site 7
Morgantown, West Virginia, 26506, United States
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Harmony Site 8
Atlanta, Georgia, 30328, United States
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Harmony Site 9
San Ramon, California, 94583, United States