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Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Phenylketonuria (PKU)

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Drug Information

Target Indication

Phenylketonuria (PKU)

Clinical Trial

NCT05270837

Last updated: 1/2/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA5/3/2019

Palynziq

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.

Orphan
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Drug Science
Mechanism of action & safety profile
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