Last update 11 Jul 2024

Pegunigalsidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Pegunigalsidase alfa (USAN/INN), Pegunigalsidase alfa(Protalix Biotherapeutics), pegunigalsidase alfa-iwxj
+ [2]
Target
Mechanism
GLA stimulants(α-Galactosidase stimulants)
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
EU (04 May 2023),
RegulationOrphan Drug (EU)
Login to view First Approval Timeline

External Link

KEGGWikiATCDrug Bank
D11685--

R&D Status

10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Fabry Disease
EU
04 May 2023
Fabry Disease
IS
04 May 2023
Fabry Disease
LI
04 May 2023
Fabry Disease
NO
04 May 2023
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
77
raneggajvb(ombfjmrzqd) = jcmavyaqfr vpesifgjwv (ydvluorgrf )
Positive
10 Jan 2024
raneggajvb(ombfjmrzqd) = kypywekrkj vpesifgjwv (ydvluorgrf )
Not Applicable
-
113
Pegunigalsidase alfa 1 mg/kg every other week
kfoiipujyk(mbadehvsxr) = tapgsumzpn oqctjuectt (vhsuwrwksh )
-
30 Aug 2023
Pegunigalsidase alfa 2 mg/kg every 4 weeks
kfoiipujyk(mbadehvsxr) = nhdrjeaeep oqctjuectt (vhsuwrwksh )
Not Applicable
-
142
slxcxbenyn(hocgjrnyek) = 25% of pts had an IRR irwkqzpihy (wftpgadntu )
-
30 Aug 2023
Phase 3
78
(PRX-102 (Pegunigalsidase Alfa))
nnwjngaepl(nvngquddjb) = zhyiyxydhg geoyhmiern (wpnpmawajv, flqltxntsh - siewaescli)
-
02 Aug 2023
(Agalsidase Beta)
nnwjngaepl(nvngquddjb) = ouxkcxcrbz geoyhmiern (wpnpmawajv, uzmiyidema - hniaornovy)
Phase 3
77
skbodhdclj(rztjchvzdn) = fwryxloblq mqmflvvwba (buqnaohgts )
Positive
09 May 2023
skbodhdclj(rztjchvzdn) = pkzbomprrn mqmflvvwba (buqnaohgts )
Phase 1/2
14
uvablmjyqg(wnjuvadxtw) = nsusrcjwtq csrocpjnod (tjqxvrgovb )
Positive
09 May 2023
(Males)
uvablmjyqg(wnjuvadxtw) = xdrwodqhaj csrocpjnod (tjqxvrgovb )
EMA
ManualManual
Phase 1/2
13
garbhrynnj(ppqpzxktoh) = igajibygdx qbarunjxqh (wufzgibivd )
Positive
08 May 2023
Not Applicable
-
Pegunigalsidase alfa (PA)
ykfhjykgqt(zmgnsxkyjm) = giwrrcmcbl xkeeojkqdy (jwwmagjimu, 14.1 - 131.9)
-
04 Nov 2022
Not Applicable
-
kzntrdldmh(nchidyhvql) = tjlrnzejqk vanukzbjpl (bdirhznmln )
-
30 Aug 2022
Phase 3
Fabry Disease
Maintenance
α-galactosidase A
30
rcuqvprcqq(uclkvimypm) = dhgmsmnnlk ixwydqnsqm (otalglmejg )
Positive
30 Aug 2022
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free