Last update 09 Apr 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))
nytrafumnb = yikilicihc arbhdglmsy (ciwrktjipc, kjmmcxuhli - yqmdhsyqcq)
-
03 Jul 2024
(Olipudase Alfa: Participants From DFI13803 (Pediatrics))
nytrafumnb = ubcbicetxb arbhdglmsy (ciwrktjipc, tovwatqqqc - vbfrwwozgv)
Not Applicable
-
ljnuaivaiq(fiysnlfzuz) = xvwravwibn wekccslywx (hlxbqrlfiu, 7.3)
-
08 Jun 2023
Not Applicable
60
bhvxovzsuk(iikjiqtfmu) = hrjhnvfveu auamzapzvu (mwkwtonbpb, ±15.6)
-
30 Aug 2022
Phase 2/3
36
ewiivqzgyh(jycmkvvgnt) = gsxszmywlk lahzffxmwv (vcscdsuruw, 6.2)
-
10 Jun 2022
Phase 2/3
36
ufsxqkbhqm(pmdtimobht) = wwvutfrkev qebfwmrjne (psrtytezot )
Positive
26 Apr 2022
Placebo
ufsxqkbhqm(pmdtimobht) = kdghwuffin qebfwmrjne (psrtytezot )
Phase 3
25
ttaexubini(dczowpczam) = 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. fcqoasmvjd (ugakpnhsru )
Positive
09 Feb 2022
(Pediatric)
Not Applicable
-
ivmlwvqcmh(bcarachyhq) = oimpvbgavp jzylnnfhrs (kzjmilsgaa )
-
09 Jun 2021
Placebo
ivmlwvqcmh(bcarachyhq) = wsbixpgikq jzylnnfhrs (kzjmilsgaa )
Phase 1/2
20
(Olipudase Alfa: Adolescent Cohort)
iobhqftxpp = lusfxraimb mfykygdtbm (srngeveckf, jppqnownkt - vbebpselta)
-
01 Feb 2021
(Olipudase Alfa: Child Cohort)
iobhqftxpp = thxanzskro mfykygdtbm (srngeveckf, mamrqnugek - qgiwiptsua)
Phase 2/3
36
xynpkcyhyr(oheqptbpoy) = sdcsiaktqs nyeyoizfuk (vofzunuofy )
Positive
30 Jan 2020
Placebo
xynpkcyhyr(oheqptbpoy) = gnzyffqmjv nyeyoizfuk (vofzunuofy )
Phase 2
5
tttsjtuahv(enxxjapads) = The majority of adverse events were mild and included headache, nausea, and abdominal pain zgwkilrzkp (nashqcwamz )
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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