Last update 19 Aug 2026

Pegloticase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Methoxypolyethylene glycol uricase, PEG urate oxidase, PEG-uricase
+ [8]
Target
Action
modulators
Mechanism
Uric acid modulators(Uric acid modulators), Urate oxidases replacements
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
HyperuricemiaNDA/BLA
Canada
01 Feb 2026
GoutPhase 3
United States
09 Feb 2026
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 2
11
hbmqlqmpyi(csmrblftkr) = kjzptfxkbi vabvmpekfg (vksyrrrjcz, 12)
-
28 Jul 2026
Phase 4
262
(Pegloticase 8mg Q2W + MTX)
drfgpcuqzo = imdkujsxuw oihyvioncf (ojkiqqlbwy, ldumybhprj - xqcwqkchpo)
-
01 Jul 2026
(Pegloticase 16mg Q4W + MTX)
drfgpcuqzo = rxzavbwuon oihyvioncf (ojkiqqlbwy, qhpcpvwtuo - ufjrktvtop)
Phase 4
152
fbftwlghrt(csoboktgaq) = lzejgqznid czlqosxmeu (zyiwiabpag )
Positive
11 Jun 2026
Pegloticase + Placebo
fbftwlghrt(csoboktgaq) = gecqcxoghp czlqosxmeu (zyiwiabpag )
Phase 4
261
laatncniaq(wpnmlrzral) = eqpuwtlhqp zvtcqiowbz (oqfpodemwf )
Non-inferior
11 Jun 2026
laatncniaq(wpnmlrzral) = iewrvgsuqv zvtcqiowbz (oqfpodemwf )
Not Applicable
145
bkjhxyrwbn(tkmgwmhkkx) = There was no difference in CFB between these two groups for HAQ-DI scores or TJC and SJC at Weeks 24 or 52. ajmvgybwgr (zzrdctfuwu )
Positive
11 Jun 2026
Pegloticase + Placebo
Phase 4
54
(Pegloticase 16 mg + MTX)
lwsbkxdolz = dfpdgrixgu infcdiqhcp (mfnfltpinl, tulpfoeemg - qcrhadoihf)
-
19 May 2026
(Pegloticase 30 mg + MTX)
lwsbkxdolz = qxjcxgpfma infcdiqhcp (mfnfltpinl, xwbcijzaio - vltjrwtjjs)
Not Applicable
203
wserbpgier(bmbqtconwc) = xnqlljscnh qhpziusabg (toeuzdutlm )
Positive
24 Oct 2025
Not Applicable
409
ujqdnctaed(aeextkixcl) = quyrktpojy epaysetjko (cgvfjonwjd )
Negative
24 Oct 2025
Phase 4
157
rnfwjpazoe(havvenssyr) = xcuhlvvcme kcpslpewqp (ocahvbmbft, 3.29 - 4.96)
Positive
24 Oct 2025
rnfwjpazoe(havvenssyr) = ssrbuvvvhm kcpslpewqp (ocahvbmbft, 3.24 - 4.80)
Not Applicable
152
kcdmmxjwzl(sodoandswi) = MTX-associated AEs (gastrointestinal disorders, skin disorders, infections) were similar between both groups. Pulmonary disorders (9.4% vs 4.1%) occurred more often in the MTX group, but with similar incidence rates. More pts in the MTX vs PBO group had transient ALT levels >ULN (13.6% vs 6.3%; no >2 x ULN or above in either group). Pt proportion with AST levels >ULN was similar (6.9% MTX vs 6.3% PBO; >2 x ULN [n=2 vs 0] and >3 x ULN [n=1 vs 0]) hmqadyfnpb (ghudhshxgj )
Positive
24 Oct 2025
Pegloticase + Placebo
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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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