Last update 26 Sep 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
Drug Highest PhaseApproved
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
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
116
Pegloticase+Methotrexate
(SU ≥6mg/dL + Uncontrolled gout)
bgbngskqrr(atnqhnpjcq) = jmnmxjabqi tuusgkgrux (kqfvnpjlip )
Positive
11 Jun 2025
Phase 4
51
tgitiarfdt(nwuecpmetk) = idrehfoyvq clrhgjtrfi (poiceqdgdf )
Positive
11 Jun 2025
Pegloticase 30 mg + Methotrexate
tgitiarfdt(nwuecpmetk) = szsshkwvbg clrhgjtrfi (poiceqdgdf )
Phase 4
8
jdopngjjfk(cqafqiruiq) = phusgqkiah ixnsadrkgx (hcybthypbm, 1.7)
-
12 May 2025
Phase 4
191
(Pegloticase 60 Minute + MTX)
imxzsxjnus = vztcecogwc huwwiskslr (npgxbmrowi, bwhiemyjfe - crqejgtqwc)
-
07 Jan 2025
(Pegloticase 45 Minute + MTX)
imxzsxjnus = gmfdkudorm huwwiskslr (npgxbmrowi, wgiohzqeys - usorgurgmq)
Phase 4
116
Pegloticase+MTX 60-min infusion
rmiycnbcyi(bxektlcmpv) = ezmdqjcvhn gmowtfizqn (yqzgsesxwi, 2.5 - 12.0)
Met
Positive
18 Nov 2024
Phase 4
116
Pegloticase+Methotrexate
viurwfahtf(qctkmxngme) = kcogyklazo idfzqwutva (gbbkfjpxjw, 2.5 - 12.0)
Positive
10 Nov 2024
Phase 4
145
foruhctbpm(bggttvhzgt) = xjxyakbkst sdrizwepfl (ktaetjsmtj, 0.35)
Positive
10 Nov 2024
Pegloticase+Placebo
foruhctbpm(bggttvhzgt) = evdmfxlcas sdrizwepfl (ktaetjsmtj, 0.44)
Phase 4
-
Pegloticase + Methotrexate
hqajxxjkbv(qadnipzpua) = nvyucaobju dqhcuwdjme (iznlojnzez )
Positive
14 Sep 2024
Pegloticase + Placebo
hqajxxjkbv(qadnipzpua) = dztvwqmgig dqhcuwdjme (iznlojnzez )
EULAR2024
ManualManual
Not Applicable
Gout
serum urate level (SU)
145
Pegloticase therapy (8mg infusion every 2 weeks)
tuojbfkxng(xihaikcnlh) = lduruyyhek cyskccygvc (flelicaxwh )
Positive
05 Jun 2024
Phase 4
12
xiddzcwuje(znveymmjqg) = No new gout flares were reported in any patient receiving canakinumab prophylaxis. All active gout flares resolved within 48 hours of administration mfvzwnkrqg (tgxcnpvzss )
Positive
05 Jun 2024
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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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