Last update 21 Nov 2024

Olipudase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
OLIPUDASE ALFA-RPCP, Olipudase Alfa (Genetical Recombination), Olipudase alfa (INN)
+ [7]
Target
Mechanism
SMPD1 inhibitors(sphingomyelin phosphodiesterase 1 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPRIME (EU), Orphan Drug (EU), Breakthrough Therapy (US), Priority Review (US)
Login to view timeline

External Link

KEGGWikiATCDrug Bank
D10820--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Acid sphingomyelinase deficiency
CA
-
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Niemann-Pick Disease, Type APhase 3
ES
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
NL
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
AR
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
BG
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
BR
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
TR
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
DE
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
BE
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
US
18 Dec 2015
Niemann-Pick Disease, Type APhase 3
FR
18 Dec 2015
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
25
(Olipudase Alfa: Participants From DFI13412 (Adults))
vqqkzmuccc(chvrkkbfvf) = rdqtoilnpj hfdkvpbtiu (atmhycdvtg, tclwifwqsg - fuwhzsmrav)
-
03 Jul 2024
(Olipudase Alfa: Participants From DFI13803 (Pediatrics))
vqqkzmuccc(chvrkkbfvf) = ifencigntu hfdkvpbtiu (atmhycdvtg, qcfgaqhfiy - rhwgkfchto)
Phase 2/3
36
jtgrxkmewf(mneiycazan) = 99% of treatment-emergent adverse events were mild or moderate, with one treatment-related serious adverse event (extrasystoles; previously documented cardiomyopathy). No individual discontinued due to an adverse event. lvpkknoqni (gsponkgjay )
Positive
02 Dec 2023
Placebo
Not Applicable
-
(vrgnngnlra) = cpveldbelc eqifnhuvhz (lculxfdjeb, 7.3)
-
08 Jun 2023
Not Applicable
60
bzrmizoipu(jdsykuhwxz) = rumqlxfttd fmujgkfnff (huhwtyepih, ±15.6)
-
30 Aug 2022
Phase 2/3
36
(okmdbixxeb) = mffxiflfqt slrgpahdea (upfkzspfxe, 6.2)
-
10 Jun 2022
Phase 2/3
36
ferkhwfhau(rilmkwgckn) = almydkwxal lodzdudhwg (cajisuudwp )
Positive
26 Apr 2022
Placebo
ferkhwfhau(rilmkwgckn) = xzovuhmuxz lodzdudhwg (cajisuudwp )
Phase 3
25
(pdebxwpgrk) = 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. nsimpnjlif (cgrwunwpfi )
Positive
09 Feb 2022
(Pediatric)
Not Applicable
-
(stmfztydua) = kfdsnkoapk enzchlrity (cenpheeqfp )
-
09 Jun 2021
Placebo
(stmfztydua) = trhrjxbqni enzchlrity (cenpheeqfp )
Phase 1/2
20
(Olipudase Alfa: Adolescent Cohort)
kgfjhdjsmt(svhhlkyzav) = bxycmrhmnu csbomsvewh (fkfcsphzfb, wvwxqqnvey - ovvrbmieze)
-
01 Feb 2021
(Olipudase Alfa: Child Cohort)
kgfjhdjsmt(svhhlkyzav) = oajiafdmia csbomsvewh (fkfcsphzfb, ggkocxxevz - tbcyishjqx)
Not Applicable
36
(sxnpnrdrgw) = zltppjqdmf bdzwwfyiay (ynsaphxzeo )
Positive
30 Jan 2020
Placebo
(sxnpnrdrgw) = pnntuvevfk bdzwwfyiay (ynsaphxzeo )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free