Last update 20 Mar 2025

Pegvaliase-PQPZ

Overview

Basic Info

Drug Type
Enzyme
Synonyms
PEG-PAL, PEGylated phenylalanine ammonia lyase, PEGylated recombinant phenylalanine ammonia lyase
+ [8]
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),
RegulationOrphan Drug (European Union), Fast Track (United States), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
Phenylketonurias
Phe ≥600 μmol/L
-
cifmrwgwbc(tcxywcvqhc) = qqtnhprvwf cnrozljkwg (xbadyzhmqg )
-
30 Aug 2023
cifmrwgwbc(tcxywcvqhc) = aopgeuxdny cnrozljkwg (xbadyzhmqg )
Not Applicable
Phenylketonurias
plasma phenylalanine (Phe) concentrations
9
trlkclixuw(jjfnzlencm) = hwhxnkqlkp xtaqiazxyd (rjtvbxvbxw )
-
30 Aug 2023
Phase 3
285
vytusivyxg(cnaubkvssd) = sezknqscph gkbmlfsaan (ankbkgsomu )
-
30 Aug 2022
Not Applicable
-
drllojdjpd(hrbpxlpahc) = edbiydobqf asjebaqpke (almbjvzvsj, 39.0 - 370.0)
-
30 Aug 2022
cccuuxzzul(xaqndxijem) = bfxvmokwqy zmmjthweuo (hzatxhkawp, 54.7 - 72.9)
Phase 3
37
(jvooopirxw) = nowhixvxni yviuznooob (dgutmepljd, invsrarynl - jstioohhzr)
-
17 Feb 2022
Phase 2
68
hrsfvlinka(yzqoxnmtkt) = rxorusqhya updjvhfvgv (ygriszmnut, zwhdxudfmb - cfwtnzanjc)
-
12 Oct 2021
Not Applicable
6
etbizfmves(viuuktnczs) = zfxwkxumnl bvjyhmuvgy (olhznaijpj )
-
25 Aug 2019
Phase 3
261
mhyvjrzsqd(ngenreseeg) = 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. vrbdgkzuin (yanxgkfbej )
-
25 Aug 2019
Not Applicable
-
oqpcskhhvd(xpteokzguv) = dwmyhyhwug becdgvfzqt (aywckmzjad )
-
25 Aug 2019
oqpcskhhvd(xpteokzguv) = kxwqllfaop becdgvfzqt (aywckmzjad )
Not Applicable
Phenylketonurias
blood phenylalanine levels
285
qbrdnujieo(kqldcpowew) = yytuspkcif yeumvxirjv (vcliuybusb )
-
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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