Palynziq
Palynziq ingredients
| Active ingredient | Strength |
|---|---|
| Pegvaliase | 2.5 mg/.5mL, 20 mg/mL, 10 mg/.5mL |
What Palynziq is used for
The FDA lists the approved uses on the official label (below). In the EU, pegvaliase is approved as Palynziq for:
Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Palynziq
- Generic name
- Pegvaliase-pqpz
- Made by
- BioMarin Pharmaceutical Inc.
- Forms
- Injection, Solution
- Given
- Subcutaneous
- Drug class
- Phenylalanine Metabolizing Enzyme
- FDA approval
- Biologic licence (BLA) BLA761079
- On the US market since
- 2018
Official information
- Palynziq prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Pegvaliase-pqpz)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Palynziq?
Palynziq (Pegvaliase-pqpz) is a specialist medicine made by BioMarin Pharmaceutical Inc., approved by the US FDA.
What are the ingredients of Palynziq?
Palynziq contains Pegvaliase (2.5 mg/.5mL, 20 mg/mL, 10 mg/.5mL).
Is Palynziq approved in Europe?
The same active substance is approved in the EU as Palynziq.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA