HomeTrialNCT05536011
NCT05536011RECRUITING

WAKIX® (Pitolisant) Pregnancy Registry

Study Summary

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment1329 participants
Primary Completion
Lead SponsorHarmony Biosciences Management, Inc.
Data Retrieved2026-04-11 04:15:56.573694+00:00
What This Trial Means for Biotech Investors
Trial Phase Context
Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 1,329 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.

Not financial advice. BiotechSign data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.