KRYSTEXXA (pegloticase)
KRYSTEXXA is indicated for the treatment of Gout; Hyperuricemia.
How KRYSTEXXA Works
KRYSTEXXA is a recombinant uricase that lowers serum uric acid by catalyzing its oxidation into allantoin. Allantoin is an inert and water-soluble purine metabolite, making it significantly easier for the body to process than uric acid. Once converted, allantoin is readily eliminated from the system, primarily through renal excretion. This enzymatic conversion directly reduces the concentration of uric acid circulating in the blood.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-09-14
- Patent Cliff
- 2017
- Revenue
- $435M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KRYSTEXXA Approval History
What KRYSTEXXA Treats
2 indicationsKRYSTEXXA is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gout
- Hyperuricemia
KRYSTEXXA Boxed Warning
ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. ( 5.1 ) KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaph...
WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. ( 5.1 ) KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. ( 5.1 , 5.2 ) Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. ( 5.2 ) Screen patients at risk for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency. ( 4 , 5.3 ) WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA See full prescribing information for complete boxed warning. Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, including a first infusion, and generally manifest within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. ( 5.1 ) KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. ( 5.1 , 5.2 ) Pre-medicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Monitor serum uric ac
KRYSTEXXA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to KRYSTEXXA
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04745910 | 2020-0330 NCI-2020-13890, 2020-0330 | Ph 4 | completed | Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome |
| NCT07388498 | 20230219 | Ph 3 | recruiting | A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout |
| NCT06229145 | HZNP-KRY-409 | Ph 4 | completed | A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout |
| NCT04762498 FORWARD OL results posted | HZNP-KRY-408 | Ph 4 | completed | A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL) |
| NCT04772313 results posted | HZNP-KRY-407 | Ph 4 | completed | Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy |
| NCT03635957 MIRROR OL results posted | HZNP-KRY-201 | Ph 4 | completed | Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout |
| NCT03994731 MIRROR RCT results posted | HZNP-KRY-202 | Ph 4 | completed | Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout |
| NCT04087720 results posted | HZNP-KRY-406 | Ph 4 | completed | Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant |
| NCT02598596 TRIPLE | AMP-001 | Ph 2 | completed | Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect |
| NCT01739660 | M0403 10122 | Ph 1 | completed | Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KRYSTEXXA FDA Label Details
Indications & Usage
FDA Label (PDF)KRYSTEXXA is indicated for the treatment of Gout; Hyperuricemia.
WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, and generally manifests within 2...
Pro Intelligence Preview
Deep insights for KRYSTEXXA
Revenue Insights
- • Q4-2025: $435M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2017
- • Generic/biosimilar risk
Trial Analysis
- • 11 total trials
- • Stage: Mature
Competitive Landscape
- • 11 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment