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New Slow-Release pill for narcolepsy passes early safety check

NCT ID NCT07051252

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

46 people

The number who actually took part.

Started

May 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1\. Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria. Exclusion Criteria: 1. Has hypersomnolence due to another medical disorder. 2. Is currently taking or has taken WAKIX (pitolisant). 3. Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening. 4. Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.

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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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