Friday, July 10, 2026

Drug profile · INN

pegvaliase-pqpz

pegvaliase-pqpz (PALYNZIQ) is a phenylalanine hydrolytic enzyme. Associated with BioMarin Pharmaceutical Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — pegvaliase-pqpz
US status
approved
Class
Route
INJECTION
Patents
0
Programs
3
Data quality
0.89

Quick answer

pegvaliase-pqpz (PALYNZIQ) is a phenylalanine hydrolytic enzyme. Associated with BioMarin Pharmaceutical Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN pegvaliase-pqpz
Brand PALYNZIQ
Mechanism Phenylalanine hydrolytic enzyme
Target Phenylalanine
Route INJECTION
Formulation INJECTABLE

Mechanism of action

Phenylalanine hydrolytic enzyme

Primary target: Phenylalanine

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Pegvaliase Phase 3 · BioMarin Pharmaceutical Australia · Phenylketonuria (PKU)
  2. Pegvaliase Approved · BioMarin Pharmaceutical Australia · Phenylketonuria
  3. RDD to Palynziq Approved · BioMarin Pharmaceutical Australia · Phenylketonuria

Related & competitor drugs

  1. pegvaliase Alimentary tract and metabolism (A16)
  2. sapropterin dihydrochloride Phenylalanine-4-hydroxylase activator

Frequently asked questions

What is pegvaliase-pqpz?

pegvaliase-pqpz (PALYNZIQ) is a phenylalanine hydrolytic enzyme. Associated with BioMarin Pharmaceutical Australia Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for pegvaliase-pqpz?

PALYNZIQ is a marketed brand name for pegvaliase-pqpz. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pegvaliase-pqpz?

pegvaliase-pqpz has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.