Our grouping. This page groups the registry's lead sponsor names by company — our grouping, not the registry's. It can be wrong or incomplete: an acquired company whose name never mentions its owner may be missing. Use “Something wrong?” under any name below to correct it.
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Harmony Biosciences Holdings, Inc. clinical trials
The registry lists 18 studies whose lead sponsor is Harmony Biosciences Holdings, Inc. or one of 2 companies grouped under it. 6 are recruiting or about to start. Per ClinicalTrials.gov, last updated Oct 6, 2026.
Keep track of what changes. Save the Harmony Biosciences Holdings, Inc. studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesRegistry sponsor names on this page
Each name exactly as ClinicalTrials.gov lists it, and how it relates to Harmony Biosciences Holdings, Inc..
- Harmony Biosciences Management, Inc.16 studies →Subsidiary
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- Zynerba Pharmaceuticals, Inc.2 studies →Acquired — became part of Harmony Biosciences Holdings, Inc., Oct 10, 2023 · source ↗
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Studies
Recruiting first, then most recently updated. Showing 18 of 18.
- Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy ParticipantsRecruitingNCT07848659Phase 1
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)RecruitingNCT07500090Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With NarcolepsyRecruitingNCT07675135Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Study of Pitolisant in Patients With Prader-Willi SyndromeRecruitingNCT06366464Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- WAKIX® (Pitolisant) Pregnancy RegistryRecruitingNCT05536011
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Study of Pitolisant in Participants With Prader-Willi SyndromeEnrolling by invitationNCT07219485Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Food Effect Study of Pitolisant Delayed-Release in Healthy Adult ParticipantsCompletedNCT07860736Phase 1
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic HypersomniaCompletedNCT05156047Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1CompletedNCT04886518Phase 2
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X SyndromeCompletedNCT04977986Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXSActive, not recruitingNCT03802799Phase 2/3
Sponsor listed in the registry: Zynerba Pharmaceuticals, Inc. · First submitted before Zynerba Pharmaceuticals, Inc. became part of Harmony Biosciences Holdings, Inc.
- A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label ExtensionCompletedNCT04257929Phase 2
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (INSPIRE)CompletedNCT05149898Phase 2
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- Drug Interaction Study of ZYN002 Transdermal Gel and Probe SubstratesCompletedNCT06930872Phase 1
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic HypersomniaCompletedNCT05458128Phase 3
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- A Study of HBS-201 (Pitolisant Delayed-release)CompletedNCT07051252Phase 1
Sponsor listed in the registry: Harmony Biosciences Management, Inc.
- Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)CompletedNCT03614663Phase 2/3
Sponsor listed in the registry: Zynerba Pharmaceuticals, Inc. · First submitted before Zynerba Pharmaceuticals, Inc. became part of Harmony Biosciences Holdings, Inc.
- Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without CataplexyNo longer availableNCT03433131
Sponsor listed in the registry: Harmony Biosciences Management, Inc.