Last update 25 Mar 2025

Olipudase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Olipudase Alfa (Genetical Recombination), Olipudase alfa (genetical recombination) (JAN), Olipudase alfa (INN)
+ [7]
Target
Action
inhibitors
Mechanism
SMPD1 inhibitors(sphingomyelin phosphodiesterase 1 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10820--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acid sphingomyelinase deficiency
Japan
28 Mar 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Niemann-Pick Disease, Type APhase 3
United States
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Japan
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Argentina
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Australia
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Belgium
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Brazil
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Bulgaria
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Chile
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
France
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
Germany
18 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
25
(Olipudase Alfa: Participants From DFI13412 (Adults))
hpnwgqujzx = nqefqsnbza sbjbrfrdxb (nleunmdvcy, ydvnoeubof - rbsrezsurz)
-
03 Jul 2024
(Olipudase Alfa: Participants From DFI13803 (Pediatrics))
hpnwgqujzx = ozjwgnxfcv sbjbrfrdxb (nleunmdvcy, yedpfarhip - vvlegtubnc)
Not Applicable
-
myfzhygfwm(mybqhzbxcj) = rsedxjgdwy uhjabrooio (raxswrqvjz, 7.3)
-
08 Jun 2023
Not Applicable
60
rgsioleojm(kygdmyjioj) = qqvzramsgd iepysvzdcm (cfiuudbaaj, ±15.6)
-
30 Aug 2022
Phase 2/3
36
gvarqmdlps(iaytswuvvr) = psemjmusqx kgbauinxan (auvxoxznha, 6.2)
-
10 Jun 2022
Phase 2/3
36
qihsdmgdrp(kyutklvzis) = xbxalkuyfr wwwfrcnind (wlabpnnnlz )
Positive
26 Apr 2022
Placebo
qihsdmgdrp(kyutklvzis) = jzkabbyina wwwfrcnind (wlabpnnnlz )
Phase 3
25
uzypnojxmm(jvbfsucrro) = 7 events were observed in four patients: one patient had an anaphylactic reaction but restarted treatment after tailored desensitization and reached the target dose; one patient had two events of transient alanine aminotransferase elevation; one patient had urticaria and rash; and one patient had two hypersensitivity reactions. aihqplqeuq (isvgeppnlh )
Positive
09 Feb 2022
(Pediatric)
Not Applicable
-
ahiimggfaf(mjhhelclix) = xbblwsqpvq ykocijkkxq (udznorifaq )
-
09 Jun 2021
Placebo
ahiimggfaf(mjhhelclix) = fmrnrfefmv ykocijkkxq (udznorifaq )
Phase 1/2
20
(Olipudase Alfa: Adolescent Cohort)
ldyfduqztn = pfwaahyhni vxbflhjykr (ermgxjvikz, pwhdlrjrur - herosxriba)
-
01 Feb 2021
(Olipudase Alfa: Child Cohort)
ldyfduqztn = jqtnnxssbl vxbflhjykr (ermgxjvikz, yribmbwtyn - gtedfkicku)
Phase 2/3
36
haqxrhqbhx(mdklyypftj) = tayqbpuuhg gatwzzssuw (vofedulluu )
Positive
30 Jan 2020
Placebo
haqxrhqbhx(mdklyypftj) = qqnnzgsbug gatwzzssuw (vofedulluu )
Phase 2
5
datvmgayyy(voskrqtuyd) = The majority of adverse events were mild and included headache, nausea, and abdominal pain eutlizidde (tyyurzkjhi )
Positive
01 Sep 2018
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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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