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Phenylketonuria

Phenylketonuria (PKU) is a rare inherited metabolic condition caused by a lack of the enzyme phenylalanine hydroxylase (PAH). This leads to a buildup of the amino acid Phe, which impacts the brain, if not managed through a low-protein diet.

Learn more about our active PKU clinical trials below. To view all BioMarin’s historical trials in PKU, click here.

Phenylketonuria Clinical Trials

NCT04404530

Trial Status Recruiting

Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU)

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NCT06305234

Trial Status Recruiting

A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)

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NCT05813678

Trial Status Recruiting

A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)

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NCT05579548

Trial Status Recruiting

A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

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NCT06780332

Trial Status Recruiting

Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

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NCT05356377

Trial Status Enrolling By Invitation

Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU

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NCT05270837

Trial Status Active Not Recruiting

Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria

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NCT04480567

Trial Status Active Not Recruiting

AAV Gene Therapy Study for Subjects with PKU

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