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Pegloticase · Krystexxa

Recombinant protein · Activator of uric acid · developed by Horizon Pharma

Approved FDA, Sep 2010

AMGN Developer

1 Registered trials

What is Pegloticase?

Pegloticase (Krystexxa) is a PEGylated recombinant uricase enzyme that catalyzes the oxidation of uric acid to allantoin, a water-soluble purine metabolite readily eliminated by renal excretion.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Krystexxa
Drug type: Recombinant protein
Targets: uric acid
Mechanism: Activator of uric acid
Pathways: purine metabolism
Therapy area: Metabolic, Musculoskeletal
Developer: Horizon Pharma (AMGN)
FDA status: Approved as Krystexxa (September 14, 2010), BLA125293 · FDA label
UNII: R581OT55EA

✅ FDA-approved uses

Chronic gout in adult patients refractory to conventional therapy

From the indications section of the FDA label (version of Jul 9, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06229145	Phase 4	Gout	Completed	AMGN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Gout

More from Horizon Pharma

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the AMGN page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z