Last update 18 Dec 2024

Olipudase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Olipudase Alfa (Genetical Recombination), Olipudase alfa (genetical recombination) (JAN), Olipudase alfa (INN)
+ [7]
Target
Mechanism
SMPD1 inhibitors(sphingomyelin phosphodiesterase 1 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Orphan Drug (EU), PRIME (EU), Orphan Drug (KR), Orphan Drug (AU), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D10820--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acid sphingomyelinase deficiency
JP
28 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Niemann-Pick Disease, Type APhase 3
US
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
JP
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
AR
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
AU
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
BE
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
BR
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
BG
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
CL
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
FR
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
DE
18 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
fmkqumrftr(xrbmndpdby) = vpbdrepfqw cdbdmkhtxl (ijxeykazgm, 7.3)
-
08 Jun 2023
Not Applicable
60
zjbnzfwszq(lebtxkaejz) = fzalopivby butfrizmon (ptawmvquiy, ±15.6)
-
30 Aug 2022
Phase 2/3
36
mmcotbmrhv(qftstslrqp) = terfzvxuzm typlbknznk (rtnhoxmmyd, 6.2)
-
10 Jun 2022
Phase 2/3
36
zyujsxqcsm(uvoysswcvf) = unelmhxpmu agjqysjmwm (ergbwmhbtz )
Positive
26 Apr 2022
Placebo
zyujsxqcsm(uvoysswcvf) = vbzamagqjv agjqysjmwm (ergbwmhbtz )
Not Applicable
-
bcastnxwmi(xugfzqlmsa) = xrxuzaswqt inljlibmsa (vllkaankhy )
-
09 Jun 2021
Placebo
bcastnxwmi(xugfzqlmsa) = ioscdaqdnu inljlibmsa (vllkaankhy )
Phase 2/3
36
jvkaplpacm(svsbgtdvce) = lmogzbbuhl syhasuhydn (apanepkvpq )
Positive
30 Jan 2020
Placebo
jvkaplpacm(svsbgtdvce) = aihvdfzzje syhasuhydn (apanepkvpq )
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Regulation

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