# WAKIX® (Pitolisant) Pregnancy Registry

> **NCT05536011** · — · RECRUITING · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 1329 (estimated)

## Conditions studied

- Pregnancy Related
- Narcolepsy

## Interventions

- **DRUG:** Pitolisant
- **DRUG:** Comparator Products

## Key facts

- **NCT ID:** NCT05536011
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** RECRUITING
- **Start date:** 2021-08-24
- **Primary completion:** 2030-06-30
- **Final completion:** 2030-06-30
- **Target enrollment:** 1329 (ESTIMATED)
- **Last updated:** 2025-08-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05536011

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05536011, "WAKIX® (Pitolisant) Pregnancy Registry". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05536011. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*