BLAINJECTIONINJECTABLEPriority Review
Approved
Sep 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
6/8 — Strong
Priority Review
KRYSTEXXA (pegloticase) by Amgen is allantoin, thereby lowering serum uric acid. First approved in 2010.
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KRYSTEXXA (pegloticase) is a pegylated uricase enzyme that converts uric acid to allantoin, a water-soluble metabolite readily excreted by the kidneys. It is indicated for chronic gout in patients refractory to conventional urate-lowering therapy. This injectable biologic addresses severe, treatment-resistant hyperuricemia by enzymatically degrading uric acid rather than inhibiting its production.
$0.179BPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Part D claims (~3,900 annually), signaling a mature, niche market with limited team expansion opportunities.
Mechanism of Action
allantoin, thereby lowering serum uric acid. Allantoin is an inert and water-soluble purine metabolite; it is readily eliminated, primarily by renal excretion.
Pharmacologic Class:
Uric Acid-specific Enzyme
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
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
Started Feb 2026
270 enrolled
Uncontrolled Gout
Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout
Started Apr 2024
2 enrolled
Tophaceous Gout
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
Started Mar 2024
262 enrolled
Gout
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
Started Mar 2021
11 enrolled
Uncontrolled Gout
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
Started Jan 2021
54 enrolled
Uncontrolled GoutChronic Gout
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.