Pegloticase

Summary

Pegloticase (CHEMBL1237025) is an approved enzyme (ATC M04AX02); indicated across 2 conditions including gout and chronic kidney disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Enzyme
• ATC class: M04AX02
• Indications: 2 conditions
• Clinical trials: 17

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1237025
Name	Pegloticase
Type	Enzyme
Max phase	4
ATC	M04AX02

Also known as: Krystexxa, Pegloticasa, Pegloticase, Puricase, PEGLOTICASE, PEGORGOTEINE

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
gout	4	MONDO:0005393	EFO:0004274
chronic kidney disease	1	MONDO:0005300	EFO:0003884

Clinical trials

Total trials: 17.

Phase distribution

Phase	Trials
PHASE4	7
PHASE2	5
PHASE3	3
PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03635957	PHASE4	COMPLETED	Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
NCT03994731	PHASE4	COMPLETED	Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
NCT04087720	PHASE4	COMPLETED	Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
NCT04745910	PHASE4	COMPLETED	Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
NCT04762498	PHASE4	COMPLETED	A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
NCT04772313	PHASE4	COMPLETED	Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
NCT06229145	PHASE4	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
NCT07388498	PHASE3	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
NCT00325195	PHASE3	COMPLETED	Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
NCT01356498	PHASE3	COMPLETED	Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
NCT00080210	PHASE2	COMPLETED	A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
NCT00111657	PHASE2	COMPLETED	Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
NCT02598596	PHASE2	COMPLETED	Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
NCT03303989	PHASE2	COMPLETED	REduCing Immunogenicity to PegloticasE (RECIPE) Study
NCT03899883	PHASE2	UNKNOWN	Uric Acid Lowering Trial in Youth Onset T2D
NCT01739660	PHASE1	COMPLETED	Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
NCT01466166	Not specified	COMPLETED	Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).