Harmony Biosciences Management
Harmony Biosciences Management sponsors 10 registered US clinical trials on ClinicalTrials.gov, 4 of them currently recruiting, and 5 completed. 5 of these trials are in Phase 3-4 (later-stage) and 4 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Prader-Willi Syndrome, with 2 trials.
Trial Pipeline
10 total, page 1 of 1
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
NCT07675135
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
NCT07500090
A Study of Pitolisant in Patients With Prader-Willi Syndrome
NCT06366464
WAKIX® (Pitolisant) Pregnancy Registry
NCT05536011
A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
NCT04257929
A Study of HBS-201 (Pitolisant Delayed-release)
NCT07051252
A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia
NCT05458128
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
NCT05156047
Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1
NCT04886518
Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (INSPIRE)
NCT05149898
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 1 |
| Phase 2 | 3 |
| Phase 3 | 5 |
Therapeutic Areas
What the Pipeline for Harmony Biosciences Management Shows
According to the ClinicalTrials.gov registry, Harmony Biosciences Management is linked to 10 US clinical trials across every stage of research activity. Of those, 4 studies are currently recruiting, about 40% of the sponsor's indexed portfolio, and 5 are already marked complete, representing roughly 50% of the total.
The phase mix for Harmony Biosciences Management reports 5 late-stage studies (Phase 3 and Phase 4 combined) and 4 earlier-phase studies (Phase 1 and Phase 2).
The top therapeutic focus area indexed for Harmony Biosciences Management is Prader-Willi Syndrome with 2 linked trials, and 2 other condition areas appear in the top list above.
How to read these pipeline numbers
Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.
A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.
That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.