Sponsor or institution
Clinical trials and research at Harmony Biosciences Management, Inc.
As of November 12, 2026, Find a Trial lists 5 clinical trials run by Harmony Biosciences Management, Inc. that are recruiting, at sites in 13 countries (most in United States (5), Canada (3), Australia (1)). By phase: Phase 3 (3), Phase 1 (1). Every study is explained in plain English. Data from ClinicalTrials.gov and NIH RePORTER, updated November 12, 2026.
- 5Clinical trials
- 13Countries
Newest trials
| Study | Phase | Where | Status | Registered |
|---|---|---|---|---|
| HBS-104 single doses in acutely sleep-deprived healthy adults | Phase 1 | Eatontown, New Jersey | Recruiting | Sep 30, 2026 |
| HBS-301 for Narcolepsy: daily wakefulness and sleepiness improvement in adults | Phase 3 | Birmingham, Alabama and 52 other locations | Recruiting | Jun 30, 2026 |
| Phase 3 HBS-301 for idiopathic hypersomnia | Phase 3 | Birmingham, Alabama and 41 other locations | Recruiting | Mar 30, 2026 |
| Evaluating pitolisant for excessive daytime sleepiness in Prader-Willi syndrome | Phase 3 | Los Angeles, California and 56 other locations | Recruiting | Apr 16, 2024 |
| Registry to evaluate pitolisant use during pregnancy | — | Morrisville, North Carolina | Recruiting | Sep 10, 2022 |
All recruiting trials (5)
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HBS-104 single doses in acutely sleep-deprived healthy adults
This study tests whether a single dose of HBS-104 is safe and how it behaves in the body when given to healthy adults who are acutely sleep-deprived.
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HBS-301 for Narcolepsy: daily wakefulness and sleepiness improvement in adults
This Phase 3 study tests HBS-301 vs placebo in adults with narcolepsy to see if it helps with daytime sleepiness, cataplexy, sleepiness, and fatigue.
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Phase 3 HBS-301 for idiopathic hypersomnia
This trial will test whether the oral medicine HBS-301 helps adults with idiopathic hypersomnia reduce daytime sleepiness, sleep inertia, and fatigue.
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Evaluating pitolisant for excessive daytime sleepiness in Prader-Willi syndrome
This study is testing if a medication called pitolisant can help reduce excessive daytime sleepiness in people aged 6 and older with Prader-Willi syndrome.
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Registry to evaluate pitolisant use during pregnancy
This study is trying to see how using pitolisant during pregnancy affects mothers and their babies, and it's open to pregnant women with and without narcolepsy.
Quick answers
How many clinical trials run by Harmony Biosciences Management, Inc. are recruiting right now?
5, as of November 12, 2026. We update this list each time we refresh our data from ClinicalTrials.gov.
Where are these trials running?
In 13 countries. The most sites are in United States (5 trials), Canada (3 trials), Australia (1 trial), Belgium (1 trial), Denmark (1 trial). Each study page lists its sites and which ones are recruiting.
What phases are they in?
Phase 3: 3, Phase 1: 1. Trials with no phase listed are usually device, behavioural or observational studies.
How do I join one?
Open a study, check the "Is this trial a fit for you?" section, then contact the study team listed on the page. They will ask a few screening questions. Asking is free and does not commit you to anything. Talk it over with your doctor first.
Find the studies that fit you
A list is a starting point. Tell us your situation in your own words and we'll rank the studies that match and explain why. It's free and needs no account.