New study tracks PKU drug safety in pregnancy and breastfeeding

NCT ID NCT05579548

Recruiting now Knowledge-focused Sponsor: BioMarin Pharmaceutical Source: ClinicalTrials.gov ↗

First seen Jan 05, 2026 · Last updated May 07, 2026 · Updated 25 times

Summary

This study watches pregnant women with PKU who take the drug Palynziq (pegvaliase) to learn how it affects their pregnancy and their baby's health. Researchers will track pregnancy outcomes and infant development for up to 50 participants. The goal is to gather safety information, not to test a new treatment.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Metabolics and Genetics in Calgary (MAGIC)
RECRUITING

Calgary, T2E 7Z4, Canada

Contact Phone: •••-•••-•••• Email: •••••@•••••
Ospedale San Paolo
RECRUITING

Milan, 20142, Italy

Contact Email: •••••@•••••
Syneos Health
RECRUITING

Wilmington, North Carolina, 28403, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Universitaetsklinikum Hamburg Eppendorf
RECRUITING

Hamburg, 20246, Germany

Contact Email: •••••@•••••

Conditions

Explore the condition pages connected to this study.

PHENYLKETONURIA, MATERNAL