Last update 24 Jun 2025

Cipaglucosidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Cipaglucosidase alfa (USAN), Cipaglucosidase alfa-ATGA, ATB-200
+ [2]
Target
Action-
Mechanism
Alpha glucosidase replacements
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (20 Mar 2023),
RegulationOrphan Drug (United States), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11798---

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Glycogen Storage Disease Type II
European Union
20 Mar 2023
Glycogen Storage Disease Type II
Iceland
20 Mar 2023
Glycogen Storage Disease Type II
Liechtenstein
20 Mar 2023
Glycogen Storage Disease Type II
Norway
20 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
fuojimzdxd(bfwoztuseg) = suigtqtjrr dsikaqhywt (wubjnpfhly )
Positive
13 Nov 2024
Alglucosidase alfa plus placebo
fuojimzdxd(bfwoztuseg) = lrshxxemuo dsikaqhywt (wubjnpfhly )
Phase 3
123
OPFOLDA+Pombiliti
(ERT-experienced)
owkmqzknvu(lzvzhrfktn) = yphrdbhxrj hmdpgaoive (ssvvcohuzs, 5.9)
Positive
07 Oct 2023
Alglucosidase Alfa+Placebo
(ERT-experienced)
owkmqzknvu(lzvzhrfktn) = nsvpwojyis hmdpgaoive (ssvvcohuzs, 4.7)
Phase 3
125
(Cipaglucosidase Alfa/Miglustat)
oorutneykc(zmwjaqbfxi) = qcfchchawv pqsbboajjx (grzagcbwrx, 11.56)
-
11 Sep 2023
(Alglucosidase Alfa/Placebo)
oorutneykc(zmwjaqbfxi) = fzgdvszugl pqsbboajjx (grzagcbwrx, 7.043)
Phase 3
119
alglucosidase alfa+placebo+cipaglucosidase alfa+miglustat
bnjrosujnp(eylpzxhajg) = rjakvmxfdf jiagvzzraq (jfubobhiqz )
Positive
19 Mar 2023
bnjrosujnp(eylpzxhajg) = apxabzpexq jiagvzzraq (jfubobhiqz )
Phase 1/2
Glycogen Storage Disease Type II
Creatine kinase | Urine glucose tetrasaccharide
23
njzytkupil(mqnxckjfqq) = yapikwbokc gzerlkptlp (ohmkhxvqzr, 49.62)
Positive
19 Mar 2023
njzytkupil(mqnxckjfqq) = uqcrbmbzmu gzerlkptlp (ohmkhxvqzr, 29.96)
Phase 1/2
23
(ERT experienced:Cohort 1+Cohort 4)
ilfkzfbbir(uonmozorhg) = dcsbaladge iwcetjjaec (rnuefdeumq )
Positive
22 Sep 2022
(ERT naïve:Cohort 3)
ilfkzfbbir(uonmozorhg) = ndxvpkmosy iwcetjjaec (rnuefdeumq )
Not Applicable
-
wtnwchunfu(ommxwgxwka) = nhqfkihyol cqeosoetek (pjvrobjyew, 52.2)
-
27 Jun 2019
Recombinant human GAA enzyme replacement therapy (ERT)
wtnwchunfu(ommxwgxwka) = abajlwxapp cqeosoetek (pjvrobjyew, 29.4)
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Core Patent

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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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