Last update 22 Jun 2024

Bucelipase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Bile salt stimulated lipase, BSSL, Exinalda
+ [3]
Target
Mechanism
CEL stimulants(carboxyl ester lipase stimulants), Lipase replacements
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Exocrine Pancreatic InsufficiencyPhase 3-02 Aug 2011
Fetal Growth RetardationPhase 3
BE
01 May 2011
Fetal Growth RetardationPhase 3
CZ
01 May 2011
Fetal Growth RetardationPhase 3
FR
01 May 2011
Fetal Growth RetardationPhase 3
DE
01 May 2011
Fetal Growth RetardationPhase 3
HU
01 May 2011
Fetal Growth RetardationPhase 3
IT
01 May 2011
Fetal Growth RetardationPhase 3
PL
01 May 2011
Fetal Growth RetardationPhase 3
RU
01 May 2011
Fetal Growth RetardationPhase 3
ES
01 May 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
415
Recombinant Bile Salt-Stimulated Lipase
bucarsetxa(fwcgfpmspu) = nhlxxdteus kbebdfvfwb (boficlhmxd )
Negative
31 May 2016
Placebo
bucarsetxa(fwcgfpmspu) = kkcwnhiuhw kbebdfvfwb (boficlhmxd )
Not Applicable
-
tnslpzqdea(iujwcjtego) = fucanlligh bseloghfbd (ktjkqtesfq )
Positive
01 Jul 2014
Placebo
matzumowct(cmfqzasauy) = poyzqrcrzm attqlojnyk (kjseucvefa )
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Approval

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Regulation

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