KRYSTEXXA

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Kidney TransplantGoutUncontrolled GoutTumor Lysis Syndrome

121 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

1

KRYSTEXXA

HHorizon Therapeutics Ireland DAC

Approved

12

Ultomiris

AstraZeneca

Phase 3

13

Prevymis

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

34

Felzartamab

Biogen

Phase 3

15

Envarsus XR

UUniversity of Wisconsin, Madison

Phase 3

26

Cytogam

JJohns Hopkins University

Phase 3

27

Zemplar

AbbVie

Preclinical

28

Cysteine Hydrochloride

Novartis

Preclinical

19

Sensipar

Amgen

Preclinical

110

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

1Show 25 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Uncontrolled Gout6 trials

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

Completed·Amgen·Phase 4·NCT04772313·11 enrolled

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

Completed·Amgen·Phase 4·NCT04762498·50 enrolled

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

Completed·Amgen·Phase 4·NCT03635957·14 enrolled

Show 3 more trials

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

Completed·Amgen·Phase 4·NCT04511702·191 enrolled

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

Completed·Amgen·Phase 4·NCT03994731·152 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·Phase 3·NCT07388498·270 enrolled

Observational Study1 trial

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

Completed·HHorizon Pharma Rheumatology LLC··NCT01466166·188 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

Kidney Transplant1 trial

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

Completed·Amgen·Phase 4·NCT04087720·20 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

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

Tolerance1 trial

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

Completed·AAmpel BioSolutions, LLC·Phase 2·NCT02598596·132 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·Approved·NCT06229145·306 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

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