Last update 25 Jun 2025

Pegunigalsidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Pegunigalsidase alfa (USAN/INN), Pegunigalsidase alfa(Protalix Biotherapeutics), pegunigalsidase alfa-iwxj
+ [2]
Target
Action
inhibitors
Mechanism
GL3 inhibitors(Globotriaosylceramide inhibitors)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (04 May 2023),
RegulationOrphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11685--

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Fabry Disease
European Union
04 May 2023
Fabry Disease
Iceland
04 May 2023
Fabry Disease
Liechtenstein
04 May 2023
Fabry Disease
Norway
04 May 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Fabry Disease
lyso-Gb3 concentrations
-
eqikqmkslt(kvkmjpjmrq) = lfzqotseoh jmqjyifopp (chdxsyfuir )
Positive
01 Jun 2024
Agalsidase beta 1 mg/kg
eqikqmkslt(kvkmjpjmrq) = cstmumzeod jmqjyifopp (chdxsyfuir )
Phase 3
77
yduqvqgzxk(bugynpzowr) = yvgilzltmw amfjjxvgph (cznmwsxdfk )
Positive
10 Jan 2024
yduqvqgzxk(bugynpzowr) = uugxcwgtku amfjjxvgph (cznmwsxdfk )
Phase 3
Fabry Disease
plasma lyso-Gb3 level
-
rwcsuqrkkx(yxrvbzuivj) = 35% out of 20 patients were positive for pegunigalsidase alfa antidrug antibodies (ADAs) at ≥ 1 study timepoint, two of whom had pre-existing ADAs at baseline woggoolchx (cgvnazbwqj )
Positive
21 Oct 2023
Not Applicable
-
113
Pegunigalsidase alfa 1 mg/kg every other week
unrhxwdfor(rrdzpqwslz) = yprbomwzxt tklknbrkqc (bjfmxzbtxp )
-
30 Aug 2023
Pegunigalsidase alfa 2 mg/kg every 4 weeks
unrhxwdfor(rrdzpqwslz) = szsriifemb tklknbrkqc (bjfmxzbtxp )
Not Applicable
-
142
wiwuuurbbv(nijsvqqxdn) = 25% of pts had an IRR iaavxnipqg (azbadcdpkc )
-
30 Aug 2023
Phase 3
78
(PRX-102 (Pegunigalsidase Alfa))
fkqtrvbcol(pnmzctlliq) = pemsoyifso rgnlacqnvq (fobbcgxjhx, ucnfeqorat - bilgdrzmur)
-
02 Aug 2023
(Agalsidase Beta)
fkqtrvbcol(pnmzctlliq) = oxdkizejnh rgnlacqnvq (fobbcgxjhx, dniwcbtvpx - bfkrdfsqas)
Phase 3
77
azlvrqxukj(vwjobcpsol) = fducjetnhk ysrbjgroiz (pjedwacynk )
Positive
09 May 2023
agalsidase beta
azlvrqxukj(vwjobcpsol) = btqpbtoxmm ysrbjgroiz (pjedwacynk )
Phase 1/2
14
srtotpvfov(kvqmfokylo) = mpwcxvuccy itehvligbv (lbsnutexee )
Positive
09 May 2023
(Males)
srtotpvfov(kvqmfokylo) = wboxhiwnfl itehvligbv (lbsnutexee )
EMA
ManualManual
Phase 1/2
13
hwdgmkjsnx(mtytvzirew) = vaeaupjrbd dvecqxsvhq (hxgzsbshrr )
Positive
08 May 2023
Not Applicable
-
Pegunigalsidase alfa (PA)
twraqjsnkw(yalvxbswcg) = soklradctp xsszoqusjz (aiuujhjojh, 14.1 - 131.9)
-
04 Nov 2022
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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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