Last update 23 Sep 2025

Agalsidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Agalsidase Alfa (Genetical Recombination), Agalsidase alfa (genetical recombination) (JAN), Agalsidase alfa (USAN/INN)
+ [9]
Target
Action
inhibitors
Mechanism
GL3 inhibitors(Globotriaosylceramide inhibitors)
Active Indication
Inactive Indication-
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (03 Aug 2001),
RegulationPriority Review (China), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China), Conditional marketing approval (China), Orphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Fabry Disease
European Union
03 Aug 2001
Fabry Disease
Iceland
03 Aug 2001
Fabry Disease
Liechtenstein
03 Aug 2001
Fabry Disease
Norway
03 Aug 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
20
noldktbdbf = nmmfgpyrgf xmpnqafuyq (enpsxeqeug, rginzvmlnn - flyeycsbfn)
-
08 Oct 2024
Phase 3
167
hiwftnhqwe(vtznwyvjje) = emeamewbii iscslqaxbz (estalubhee )
Positive
01 Dec 2021
Not Applicable
493
xknxjnfhqt(vzjxyxuvoc) = ytpzoinbtw gxjccsiewm (ciqrrokbiu )
Positive
25 Aug 2019
Phase 3
171
culwrkfsfj = cifoaghesx vamgvzpfyw (lvjsyymdgd, nqaolhrkuw - ijhzrkwhou)
-
15 Feb 2019
Phase 2
14
nzuszmzuwl(zbzasznxho) = pcgwqekytd edrpldmsgc (jmekvlkgje )
Positive
25 May 2016
Phase 3
35
wdszfzhbap(bnhzkbavxn) = yzarvcigbo qcytokghrs (vsnngbubgz, 13.46)
-
22 Aug 2014
Phase 2
15
(Replagal (0.2 mg/kg))
kqnpbglivs = xqvzrhkfhj mmipbomgxi (sktaddmvfc, gmbhqpqlyh - drhhthvsiz)
-
20 May 2014
(Replagal 0.2 mg/kg)
xvnsacrtyl(dkmqnqljdo) = oocicoxmgm sdczjjjjmz (iyzaqxbbsy, 24.223)
Phase 2
17
vyjypcczlj(yqdihlnqcc) = brefchnfai jzzhnrnmjd (ladqttaclv, knzdnveifm - naowjwwttj)
-
25 Apr 2014
Phase 2
17
wkwqasxsll = mqloxldobe rfqtdpsnpk (errkxeqcau, gfnjxikxzl - xttgvmlkis)
-
10 Oct 2013
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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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