Imiglucerase

Overview

Human Beta-glucocerebrosidase or Beta-D-glucosyl-N-acylsphingosine glucohydrolase E.C. 3.2.1.45. 497 residue protein with N-linked carbohydrates, MW=59.3 kD. Alglucerase is prepared by modification of the oligosaccharide chains of human Beta-glucocerebrosidase. The modification alters the sugar residues at the non-reducing ends of the oligosaccharide chains of the glycoprotein so that they are predominantly terminated with mannose residues.

Indication

For the treatment of Gaucher's disease (deficiency in glucocerebrosidase)

Associated Conditions

Gaucher Disease, Type 1
Gaucher Disease, Type III

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3	2022/02/03	NCT05222906	Phase 3	Active, not recruiting	Sanofi
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers	2021/03/09	NCT04787887	Phase 1	Completed	ISU Abxis Co., Ltd.
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ	2020/12/07	NCT04656600	Phase 4	Completed	Sanofi
Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3	2018/04/02	NCT03485677	Phase 3	Active, not recruiting	Sanofi
Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension	2016/07/25	NCT02843035	Phase 2	Active, not recruiting	Genzyme, a Sanofi Company
Phase III Study of ISU302 in Patients With Type 1 Gaucher Disease	2016/05/12	NCT02770625	Phase 3	Completed	ISU Abxis Co., Ltd.
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers	2013/06/19	NCT01881633	Phase 1	Completed	ISU Abxis Co., Ltd.
The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease	2010/07/14	NCT01161914	Phase 3	Withdrawn	ISU Abxis Co., Ltd.
Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1)	2010/06/03	NCT01136304	N/A	Completed	University Research Foundation for Lysosomal Storage Diseases, Inc.
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)	2009/07/22	NCT00943111	Phase 3	Completed	Genzyme, a Sanofi Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cerezyme	Genzyme Corporation	58468-4663	INTRAVENOUS	40 U in 1 mL	4/10/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Cerezyme	Sanofi B.V.,Paasheuvelweg 25,1105 BP Amsterdam,Netherlands	Authorised	11/17/1997

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Cerezyme® (Imiglucerase) 400U Powder for solution for injection	Genzyme Ireland Ltd	SIN13842P	INJECTION, POWDER, FOR SOLUTION	424 U	7/27/2010

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Imiglucerase for Injection	Sanofi B.V.	国药准字SJ20140067	生物制品	注射剂	10/26/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CEREZYME imiglucerase-rch 400U powder for injection vial	74277	Sanofi-Aventis Australia Pty Ltd	Medicine	A	7/4/2000

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