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 |
|---|---|---|---|---|---|
2022/02/03 | Phase 3 | Active, not recruiting | |||
2021/03/09 | Phase 1 | Completed | |||
2020/12/07 | Phase 4 | Completed | |||
2018/04/02 | Phase 3 | Active, not recruiting | |||
2016/07/25 | Phase 2 | Active, not recruiting | Genzyme, a Sanofi Company | ||
2016/05/12 | Phase 3 | Completed | |||
2013/06/19 | Phase 1 | Completed | |||
2010/07/14 | Phase 3 | Withdrawn | |||
2010/06/03 | N/A | Completed | University Research Foundation for Lysosomal Storage Diseases, Inc. | ||
2009/07/22 | Phase 3 | Completed | Genzyme, a Sanofi Company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genzyme Corporation | 58468-4663 | INTRAVENOUS | 40 U in 1 mL | 4/10/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
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 | SIN13842P | INJECTION, POWDER, FOR SOLUTION | 424 U | 7/27/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 | Medicine | A | 7/4/2000 |
Health Canada Drug Approvals
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CEREZYME 400 UNIDADES POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 97053003 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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