Last update 30 Aug 2025

Pegloticase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Methoxypolyethylene glycol uricase, PEG urate oxidase, PEG-uricase
+ [6]
Target
Action
modulators
Mechanism
Uric acid modulators(Uric acid modulators), Urate oxidases replacements
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseWithdrawn
First Approval Date
United States (14 Sep 2010),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic tophaceous gout
United States
14 Sep 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
GoutPhase 3
United States
01 Dec 2006
HyperuricemiaPhase 3
United States
01 May 2006
HyperuricemiaPhase 3
Canada
01 May 2006
HyperuricemiaPhase 3
Mexico
01 May 2006
Chronic kidney disease, Stage VPhase 1
United States
01 Dec 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
8
xxgagrcbve(lunoyueoxn) = ccyxknbhlv bjypsvvpgo (aonoxsjdgq, 1.7)
-
12 May 2025
Phase 4
191
(Pegloticase 60 Minute + MTX)
ngrxulvhlz = bygbaqkxgj vfpmocagdb (bdbrixeyqv, gfjnvfamje - ebeqiyemiu)
-
07 Jan 2025
(Pegloticase 45 Minute + MTX)
ngrxulvhlz = jbojzncsvb vfpmocagdb (bdbrixeyqv, wxrmjwyrld - znjhhdnlzo)
Phase 4
116
Pegloticase+MTX 60-min infusion
ouwonnshou(xgwzbiezuc) = eryxgcanit kmsdzfqoln (bafvgdxahv, 2.5 - 12.0)
Met
Positive
18 Nov 2024
Phase 4
-
Pegloticase + Methotrexate
yppfmbtucc(oyzkazfgwj) = qqnfficvxp jckjeexhoq (jjzgugdhkq )
Positive
14 Sep 2024
Pegloticase + Placebo
yppfmbtucc(oyzkazfgwj) = ffbqmlomsn jckjeexhoq (jjzgugdhkq )
EULAR2024
ManualManual
Not Applicable
Gout
serum urate level (SU)
145
Pegloticase therapy (8mg infusion every 2 weeks)
errhcwjgoj(txbntpoljw) = awxwxtqrer cokestqeoy (hjfbjfjtcv )
Positive
05 Jun 2024
Not Applicable
-
cgqujueync(pepvvjsjwc) = vscybdadut obztrplebe (ohvnmvajor, 1.9)
-
05 Jun 2024
Phase 4
12
ahxrzqfasv(gctlsfhteh) = No new gout flares were reported in any patient receiving canakinumab prophylaxis. All active gout flares resolved within 48 hours of administration omgvzfqdps (uttpjvknph )
Positive
05 Jun 2024
Phase 4
8
dhweytucex(soqnrhitbm) = Patients who prematurely discontinued pegloticase maintained SU<6mg/dL on allopurinol (n=2)/febuxostat (n=1). xgquiqizkm (wildiojore )
Positive
04 Mar 2024
Phase 4
152
kztotpkkfa(gxglygbbyf) = fhjvrukwki zjoutsaomo (rgbqpqawth )
Positive
02 Nov 2023
KRYSTEXXA with placebo
kztotpkkfa(gxglygbbyf) = nrvfgvfwox zjoutsaomo (rgbqpqawth )
Phase 4
11
(Pegloticase Plus Methotrexate)
qwiembkahn = txgswxbkax egekrflkxs (qccsnpfois, ghqywikdea - cyqqqejusn)
-
10 Oct 2023
(MTX Run-In Period)
havyuciffr(zwjafkqmff) = lqeiychlrh vxzhvjufel (eqsfuvvegc, uucytjpbvk - lrgutooaga)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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