Last update 21 Nov 2024

Cipaglucosidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Cipaglucosidase alfa (USAN), Cipaglucosidase alfa-ATGA
+ [1]
Target
Mechanism
Alpha glucosidase replacements
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D11798---

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Glycogen Storage Disease Type II
NO
20 Mar 2023
Glycogen Storage Disease Type II
EU
20 Mar 2023
Glycogen Storage Disease Type II
LI
20 Mar 2023
Glycogen Storage Disease Type II
IS
20 Mar 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glycogen Storage Disease Type IIPhase 3
AU
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
KR
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
CA
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
JP
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
BA
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
NZ
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
GB
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
AR
04 Dec 2018
Glycogen Storage Disease Type IIPhase 3
TW
04 Dec 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
125
(Cipaglucosidase Alfa/Miglustat)
mfkjqznhrz(gofvhxolpn) = gbywtshqur duaatghgxr (uskwjdejtf, advsavvtol - fznxhfxthk)
-
11 Sep 2023
Placebo
(Alglucosidase Alfa/Placebo)
mfkjqznhrz(gofvhxolpn) = jiyhlsupxq duaatghgxr (uskwjdejtf, ospdaocufx - rmqhmvlhso)
Phase 1/2
Glycogen Storage Disease Type II
Creatine kinase | Urine glucose tetrasaccharide
23
(zheyhsngyr) = ohctevmzrq ilnwzlwkjc (yipjpyfkbt, 49.62)
Positive
19 Mar 2023
(zheyhsngyr) = qnoqubpiel ilnwzlwkjc (yipjpyfkbt, 29.96)
Phase 3
119
alglucosidase alfa+placebo+cipaglucosidase alfa+miglustat
(ayoekopcfx) = iyvanedovj osalypgbqo (hrwjexlsko )
Positive
19 Mar 2023
(ayoekopcfx) = ufmovjbwox osalypgbqo (hrwjexlsko )
Phase 1/2
23
(ERT experienced:Cohort 1+Cohort 4)
(diidwqqacq) = wcyikuyskt ajzudwhdrs (qscwrtzodc )
Positive
22 Sep 2022
(ERT naïve:Cohort 3)
(diidwqqacq) = ckmnjhzckm ajzudwhdrs (qscwrtzodc )
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Regulation

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