KRYSTEXXA

LOE Approaching

pegloticase

BLAINJECTIONINJECTABLEPriority Review
Approved
Sep 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8

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

Clinical Trials (5)

NCT07388498Phase 3Recruiting

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
NCT06229145Phase 4Active Not Recruiting

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
NCT04772313Phase 4Completed

Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy

Started Mar 2021
11 enrolled
Uncontrolled Gout
NCT04762498Phase 4Completed

A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)

Started Jan 2021
50 enrolled
Uncontrolled GoutChronic Gout
NCT04511702Phase 4Completed

Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

Started Oct 2020
191 enrolled
Chronic Uncontrolled GoutGoutUncontrolled Gout
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.