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WAKIX® (Pitolisant) Pregnancy Registry

WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring

Who can join

All ages · Women

Inclusion Criteria:

* Pregnant woman of any age
* Consent to participate
* Authorization for her HCP(s) to provide data to the registry
* For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)
* For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy

Exclusion Criterion:

• Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)

About the study

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.

What is being tested

• Pitolisant (drug)
• Comparator Products (drug)

Sponsor: Harmony Biosciences Management, Inc. · Participants: 1,329 · Started: Aug 24, 2021

Contact the study team

• WAKIX Pregnancy Registry Associate · Phone: 1-877-302-2813

Official record on ClinicalTrials.gov — NCT05536011

Locations in the U.S.

Conditions

• Narcolepsy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.