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NCT07219485Phase 3ENROLLING BY INVITATION

A Study of Pitolisant in Participants With Prader-Willi Syndrome

Study Summary

The purpose of this study is to assess safety of pitolisant in eligible participants with Prader-Willi syndrome (PWS) who completed the End of Treatment (EOT) visit in a parent study (HBS-101-CL-002 \[Open Label Extension (OLE)\], HBS- 101-CL-004, or HBS-101-CL-312 OLE).

Conditions
Prader-Willi Syndrome
Interventions / Drugs
Pitolisant
View on ClinicalTrials.gov ↗
Sponsor
HRMY
Harmony Biosciences
Neuroscience
B77/100
Study Details
Enrollment150 participants
Primary Completion—
Lead SponsorHarmony Biosciences Management, Inc.
Data Retrieved2026-04-11 04:15:56.573645+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Current status: ENROLLING BY INVITATION.

Enrolled: 150 participants
Sponsor Catalyst Profile

Harmony Biosciences (HRMY) is the sponsoring company for this trial. BiotechSign currently grades this company B (77/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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