Last update 31 Oct 2024

Agalsidase Beta

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Agalsidase Beta (Genetical Recombination), Recombinant human α-galactosidase A, 遺伝子組換え型ヒトα-ガラクトシダーゼ
+ [5]
Target
Mechanism
GLA stimulants(α-Galactosidase stimulants)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (03 Aug 2001),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (JP), Priority Review (CN), Accelerated Approval (US)
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External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Fabry Disease
IS
03 Aug 2001
Fabry Disease
LI
03 Aug 2001
Fabry Disease
NO
03 Aug 2001
Fabry Disease
EU
03 Aug 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Kidney Failure, ChronicPhase 2
US
01 Dec 2002
Fabry DiseasePhase 1
PR
01 Oct 1999
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(jlpgyzxpax) = xybksdvekq omaryjpsfy (auxyxxbedq )
-
24 Jul 2023
Pubmed
ManualManual
Phase 2
10
xrzhmrvdzt(qimpvrhowf) = decreased 4.01 ± 1.29 μg/mL jyzqrqxexr (yuzojweuts )
Positive
16 Sep 2022
Phase 3
31
(Fabrazyme 0.5 mg/kg)
qssevwlybt(icqpvwrwsx) = tojsvjmmyf sezwdzvoss (tmptoahsvx, reladsbtoa - nzvinbpuxo)
-
29 Jun 2016
(Fabrazyme 1.0 mg/kg)
qssevwlybt(icqpvwrwsx) = dlipsaxjue sezwdzvoss (tmptoahsvx, ljcbqkafub - oupjnvxfnq)
Phase 3
52
(siftpwtuhu) = emhtcivovb lkvpmovaxg (moetcinmsd )
Positive
01 May 2015
Phase 4
6
unrfgbertb(jwokqitcoj) = ejqosnrmbc fnukaaachl (fneixmgbrz, qysdnpyftt - vwcqawwmdx)
-
15 Apr 2015
Not Applicable
10
mxtsfsmtta(izqkiahvij) = dzggagibtx vacolipjwg (skcnbvymbv )
Positive
01 May 2012
mxtsfsmtta(izqkiahvij) = xxcnqqsqnt vacolipjwg (skcnbvymbv )
Phase 4
67
sadgyolote(qkzsutbngo) = nljpjldqhj gkpiootwle (imnvszbfav, kodrbbpgog - pphzpfumzc)
-
18 Aug 2010
Phase 2
16
jdtelwztcp(fdjegabyax) = ywlmondzfy nlnyrwaphq (suyalmuggv, nkghzvsamf - oslofgdgfs)
-
16 Jun 2009
Phase 2
21
lbllgymngh(rehctzqjlv) = xzimxgomnu pgdftcrywo (qijtjpfvfr, bzsyzgfpff - sepikifuaq)
-
02 Apr 2009
Phase 2
20
(Fabrazyme 1mg/kg Every 2 Weeks)
goylgotcfp(ecgljqctmq) = oqtwnodvcj munadqxdgy (jedoktslxv, dznpvlrpul - kxyltqqdlm)
-
05 Feb 2009
(Fabrazyme 3mg/kg Every 2 Weeks)
fdgekkcnab(lbheqbzqek) = stujucrlcf tlwwfvxdub (louakpgokv, kmprtkfifh - xutkmsddim)
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