KRYSTEXXA

(Pegloticase)

ApprovedProtein / enzyme

HHorizon Therapeutics Ireland DAC

KRYSTEXXA is one of 63 biologic programs targeting Kidney Transplant. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Kidney TransplantActive, not recruiting

Tumor Lysis SyndromeActive, not recruiting

GoutCompleted

Uncontrolled GoutRecruiting

Kidney TransplantApproved

Active, not recruiting

Tumor Lysis SyndromeApproved

Active, not recruiting

GoutApproved

Completed

Uncontrolled GoutPhase 3

Recruiting

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

KRYSTEXXA

HHorizon Therapeutics Ireland DAC

Approved

1 2

Simulect

Novartis

Preclinical

15 3

Medrol

Pfizer

Preclinical

12 4

Zinbryta

Roche

Preclinical

6 5

Zemplar

AbbVie

Preclinical

2 6

Cysteine Hydrochloride

Novartis

Preclinical

1 7

Radicava

Shionogi

Preclinical

1 8

Jardiance

Boehringer Ingelheim

Preclinical

3 9

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 10

Cytovene

EExela Pharma Sciences, LLC.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Tumor Lysis Syndrome

NCT04745910

Q2 2028

Phase 3Recruiting

Uncontrolled Gout

NCT07388498

Clinical

Trials by Indication[1]

Uncontrolled Gout6 trials

Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

Completed· Amgen logo

Amgen·Phase 4·NCT03994731·152 enrolled

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

Completed· Amgen logo

Amgen·Phase 4·NCT04511702·191 enrolled

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

Completed· Amgen logo

Amgen·Phase 4·NCT04762498·50 enrolled

Show 3 more trials

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

Completed· Amgen logo

Amgen·Phase 4·NCT04772313·11 enrolled

Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout

Completed· Amgen logo

Amgen·Phase 4·NCT03635957·14 enrolled

A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout

Recruiting· Amgen logo

Amgen·Phase 3·NCT07388498·270 enrolled

Tolerance1 trial

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

Completed·AAmpel BioSolutions, LLC·Phase 2·NCT02598596·132 enrolled

Kidney Transplant1 trial

Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant

Completed· Amgen logo

Amgen·Phase 4·NCT04087720·20 enrolled

Observational Study1 trial

Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout

Completed·HHorizon Pharma Rheumatology LLC··NCT01466166·188 enrolled

Tumor Lysis Syndrome1 trial

Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT04745910·10 enrolled

5 more indications

Refractory Gout1 trial

Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

Completed·JJohn Sundy·Phase 2·NCT00111657·30 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

Completed·SSavient Pharmaceuticals·Phase 3·NCT00325195·225 enrolled

Hemodialysis1 trial

Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis

Completed·SSavient Pharmaceuticals·Phase 1·NCT01739660·12 enrolled

Double-blind1 trial

Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

Completed·SSavient Pharmaceuticals·Phase 3·NCT01356498·151 enrolled

Gout1 trial

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)

Completed· Amgen logo

Amgen·Approved·NCT06229145·262 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 14, 2010

KRYSTEXXA

BLA BLA125293

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Pegloticase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pegloticase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pegloticase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125293). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Horizon Therapeutics Ireland DAC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: HHorizon Therapeutics Ireland DAC

KRYSTEXXA

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q2 2028

Trials by Indication[1]

Uncontrolled Gout6 trials

Tolerance1 trial

Kidney Transplant1 trial

Observational Study1 trial

Tumor Lysis Syndrome1 trial

Refractory Gout1 trial

Safety and Efficacy1 trial

Hemodialysis1 trial

Double-blind1 trial

Gout1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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