Pregnancy safety of narcolepsy drug pitolisant under scrutiny

NCT ID NCT05536011

Recruiting now Knowledge-focused Sponsor: Harmony Biosciences Management, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks pregnant women with narcolepsy who take pitolisant (Wakix) or other narcolepsy medications, as well as pregnant women without narcolepsy who take pitolisant. Researchers compare pregnancy outcomes, including birth defects, to see if the drug poses risks. The goal is to gather real-world safety data to guide treatment decisions during pregnancy.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Pitolisant (Wakix)
What this could lead to: If safe, this could provide reassurance for pregnant women needing narcolepsy treatment.
What could go wrong: This is an observational study, not a controlled trial, so it can show associations but not prove cause and effect. Results may take years.

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Conditions

The condition(s) this trial relates to.

narcolepsy pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NARCOLEPSY PREGNANCY RELATED

Contacts and locations

Locations

Evidera (PPD)
RECRUITING

Morrisville, North Carolina, 28403, United States

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