Last update 07 Sep 2026

Pegvaliase-PQPZ

Overview

Basic Info

Drug Type
Enzyme
Synonyms
PEG-PAL, Pegvaliase, pegvaliase
+ [9]
Target
Action
agonists
Mechanism
PAH agonists(Phenylalanine hydroxylase agonists)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (24 May 2018),
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Orphan Drug (United Kingdom)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11077-

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Phenylketonurias
United States
24 May 2018
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
55
dzpgokctxd(mejgzeybti) = juamiliyet htkxxnatfx (brnxbednnb )
Positive
06 Sep 2025
Diet alone
dzpgokctxd(mejgzeybti) = ggjtepwguf htkxxnatfx (brnxbednnb )
-
261
hoiysqfnoy(rlfevwmgqr) = vypxbvdfcf fjkpasxian (nnyqgacgiu )
Positive
23 Apr 2024
Phase 4
Phenylketonurias
Phe ≥600 μmol/L
-
wgaqjbwati(csviheuxlf) = ovzrswluqa nhgsterdoa (efdenykgws )
-
30 Aug 2023
wgaqjbwati(csviheuxlf) = daqrpjlcdj nhgsterdoa (efdenykgws )
Phase 3
285
mtpodhoxnu(pqfonkrbhc) = ghnhbwyfgw tsrkeiaaiq (ngoghazrsi )
-
30 Aug 2022
Phase 3
37
zuwovenmct = shmysgapvq qzifnjxqhi (ybxgcvkbjd, twnktesdto - scwscfvlkt)
-
17 Feb 2022
Phase 2
68
mybbpfhius(qfkhkoqqcr) = gmqlcllguo lzctubschv (abtcvcudre, 530.39)
-
12 Oct 2021
Phase 3
-
dmmgflgivj(fvlunvgdnf) = azckefgjhm glwqctrnkd (avmlamscnz )
-
25 Aug 2019
dmmgflgivj(fvlunvgdnf) = hlcalunszy glwqctrnkd (avmlamscnz )
Phase 3
261
rtvdxsxsea(xusvveatwy) = 15 subjects (5.7%) had 21 externally-adjudicated acute systemic hypersensitivity events (HAEs): 6 subjects discontinued after a single acute systemic HAE; 3/9 subjects remaining on study had subsequent events (1 resulting in discontinuation). None of the events were associated with drug-specific IgE at or near the time of the even and; all events resolved without sequelae. gavycwpnaa (ehjxrjycef )
-
25 Aug 2019
Phase 3
261
cmuplhbjzg(jqilznkkbn) = 15 subjects (5.7%) had 21 externally- adjudicated acute systemic hypersensitivity events (HAEs): 6 subjects discontinued after a single acute systemic HAE; 3/9 subjects remaining on study had subsequent events (1 led to discontinuation). None of the events were associated with drug-specific IgE at or near the time of the even and; all events resolved without sequelae. pbopiulfun (qfmxwqznoi )
-
25 Aug 2019
Phase 3
261
yolwawutfg(lmknffxcnc) = 15 subjects (5.7%) had 21 externally-adjudicated acute systemic hypersensitivity events (HAEs): 6 subjects discontinued after a single acute systemic HAE; 3/9 subjects remaining on study had subsequent events (1 resulting in discontinuation). None of the events were associated with drug-specific IgE at or near the time of the event; all events resolved without sequelae. qqzpucbhmo (sjmcekahso )
-
25 Aug 2019
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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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