Quick answers
- What is Pegloticase used for?
- The FDA-approved label (Krystexxa, Horizon Therapeutics USA, Inc., July 9, 2026) says: “KRYSTEXXA ® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pegloticase have a boxed warning?
- Yes. The FDA label for Krystexxa has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pegloticase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pegloticase been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pegloticase?
- 1 company lists prescription products of Pegloticase in the FDA NDC Directory, including Horizon Therapeutics USA, Inc..
What Pegloticase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KRYSTEXXA ® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. …
— FDA label: Krystexxa, Horizon Therapeutics USA, Inc., effective July 9, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Krystexxa |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Horizon Therapeutics USA, Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125293 KRYSTEXXA | Horizon Pharma | September 14, 2010 | 13, latest August 7, 2026 2026: Labeling · 2022: Efficacy · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1011653, 1011657, 2723378, 2723381 |
|---|---|
| SPL set ID of the quoted label | 6e566303-d93a-4130-b764-25749829aa95 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125293 |
| Active ingredients (FDA) | PEGLOTICASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Krystexxa, Horizon Therapeutics USA, Inc., effective July 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →