PALomino Study: Palynziq Exposure During Pregnancy and Breastfeeding
This Phase 4 observational study evaluates maternal, fetal, and infant outcomes following exposure to Palynziq (pegvaliase) during pregnancy and breastfeeding in individuals with phenylketonuria (PKU).
Overview Who may qualify Canadian site Therapy background History & publications Official record
Study overview
Official title
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq (Pegvaliase) During Pregnancy and Breastfeeding
Condition
Phenylketonuria (PKU), Maternal PKU
Intervention / focus
Pegvaliase (Palynziq)
Sponsor
BioMarin Pharmaceutical Inc.
ClinicalTrials.gov ID
NCT05579548
Estimated enrollment
50 participants
Last checked by CanPKU+
March 10, 2026
If you notice that this information is outdated or incorrect, please email website@canpku.org.
Who may qualify
- Have phenylketonuria (PKU)
- Have been treated with pegvaliase
- Were exposed to pegvaliase during pregnancy or within 2 weeks prior to last menstrual period
- Agree to allow healthcare providers to share relevant medical information
Important: Final eligibility is always determined by the study team.
Canadian site information
Metabolics and Genetics in Calgary (M.A.G.I.C. Clinic)
Calgary, Alberta, Canada
Contact
Dr. Aneal Khan
Phone: 587-885-3158
Email: aneal.khan@discoverydna.ca
For additional sites worldwide, please consult the official study record.
Therapy background
Palynziq (pegvaliase) is an enzyme substitution therapy used in adults with PKU who have uncontrolled blood phenylalanine levels.
The PALomino study collects observational safety data on pregnancy outcomes and infant development following pegvaliase exposure during pregnancy and breastfeeding.
History and publications
PALomino Study Design Poster
View poster
This poster describes the global observational design evaluating maternal, fetal, and infant outcomes following pegvaliase exposure during pregnancy.