PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

PKUDOS Registry Inclusion Criteria: * Patient has confirmed diagnosis of PKU with hyperphenylalaninemia documented by a Phenylalanine level of greater than or equal to 360 umol/L (6 mg/dL) * Patient has previously received Kuvan * Patient is currently receiving Kuvan * Patient intends to receive Kuvan therapy within 90 days of enrollment into the registry * The Patient is being followed at a PKUDOS participating center * Willing and able to provide written authorization or, if under the age of 18 years, provide written assent (if required) and written patient authorization by a parent or legal guardian * Willing to provide personal health information Exclusion Criteria: * Patients are not eligible to participate in PKUDOS if they are participating in a BioMarin-sponsored clinical study of Kuvan * Patients not previously treated with Kuvan and patients that are unwilling to begin Kuvan therapy within 90 days of entry into the registry PKU MOMS Subregistry Inclusion Criteria: * Willing to enroll in (or are already enrolled in) PKUDOS * Agree to follow the standard of care for pregnant women with PKU in the United States (NIH, 200, NIH Consensus Statement) * Agree to be followed by a hospital or PKU clinic offering the standard of care for maternal PKU * Are within 10 weeks of their last menstrual period Exclusion Criteria: * Patients who have not adhered to the standard of care for pregnant women with PKU in the United States are not eligible to participate in PKU MOMS