PALYNZIQ

Peak

pegvaliase-pqpz

BLAINJECTIONINJECTABLEPriority Review
Approved
May 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
6

Mechanism of Action

Pegvaliase-pqpz is a PEGylated phenylalanine ammonia lyase (PAL) enzyme that converts phenylalanine to ammonia and trans -cinnamic acid. It substitutes for the deficient phenylalanine hydroxylase (PAH) enzyme activity in patients with PKU and reduces blood phenylalanine concentrations.

Pharmacologic Class:

Phenylalanine Metabolizing Enzyme

Clinical Trials (5)

NCT06780332Phase 4Recruiting

Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

Started Jan 2025
10 enrolled
PhenylketonuriaPKU
NCT06305234N/ARecruiting

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

Started Jan 2024
200 enrolled
Phenylketonuria (PKU)
NCT05579548N/ARecruiting

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

Started Nov 2022
50 enrolled
Phenylketonuria, Maternal
NCT05813678N/ARecruiting

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

Started Jun 2022
450 enrolled
Phenylketonuria (PKU)
NCT05356377N/ACompleted

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

Started May 2022
6 enrolled
Phenylketonurias