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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date23 May 1994 |
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MechanismSMPD1 inhibitors |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Phase 3 Randomized, Double-blinded, Active-controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta).
A randomized, double-blind, 2-treatment, 2-period, crossover phase I study to compare the pharmacokinetics, safety and tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme® in healthy volunteers following a single intravenous administration.
A Randomized, Double-blind, 2-treatment, 2-period, Crossover Phase I Study to Compare the PK, Safety and Tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme® in Healthy Volunteers Following a Single Intravenous Administration
Primary Objective:
To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.
Secondary Objective:
To compare the safety, tolerability and immunogenicity of Abcertin to the reference formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.
100 Clinical Results associated with ISU Abxis Co., Ltd.
0 Patents (Medical) associated with ISU Abxis Co., Ltd.
100 Deals associated with ISU Abxis Co., Ltd.
100 Translational Medicine associated with ISU Abxis Co., Ltd.