agalsidase beta
Trade name: Fabrazyme
Approved
Apr 24, 2003
α-Galactosidase is a glycoside hydrolase enzyme that catalyses the following reaction:Hydrolysis of terminal, non-reducing α-D-galactose residues in α-D-galactosides, including galactose oligosaccharides, galactomannans and galactolipids — Wikipedia
Clinical trial activity
30 trials · 20 clinical orgs · 1 marketing orgs
Earliest trial started Oct 1, 1999 (NCT00074971)
Timeline
Indications
Approved for
Mechanism of action
- Alpha-galactosidase AACTIVATOR
GLA activator
Agalsidase alfa catalyses the hydrolysis of globotriaosylceramide (Gb3), cleaving a terminal galactose residue from the molecule. It counteracts the deficient activity of the lysosomal enzyme alpha-galactosidase A in the Fabry disease. Treatment with the enzyme has been shown to reduce accumulation of Gb3 in many cell types including endothelial and parenchymal cells.
- GlobotriosylceramideHYDROLYTIC ENZYME
Globotriosylceramide hydrolytic enzyme
- Alpha-galactosidase ASupplementation
GLA supplementation
Approval history
- approvedAcceleratedApr 24, 2003
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaΑ-Galactosidase ↗
- NCATSRZD65TSM9U ↗
- ChEMBLCHEMBL2108888 ↗
- WikipediaAlpha-galactosidase ↗
Also known as
- agalsidase
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta
- agalsidase beta (genetical recombination)
- alpha-d-galactopyranosidase
- alpha-d-galactosidase
- alpha-d-galactosidase a
- alpha-d- galactoside galactohydrolase
- alpha-galactisidase
- alpha-galactosidase
- alpha-galactosidase a
- alpha-galactosidase a precursor
- ec 3.2.1.22
- fabrazyme
- fabrazyme
- fabrazyme
- fabrazyme
- fabrazyme
- gc1119
- melibiase
- recombinant human alpha-galactosidase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06019728 | Phase 4 | Nov 10, 2023 | Sanofi |
| NCT06081062 | Phase 3 | Apr 14, 2023 | ISU Abxis Co., Ltd. |
| NCT06630312 | Early Phase 1 (Phase 1) | Mar 28, 2023 | Iowa State University |
| NCT05843916 | Phase 3 | Dec 13, 2022 | Bio Sidus SA |
| NCT05280548 | Phase 3 | May 3, 2022 | Genzyme, Sanofi |
| NCT05343715 | Phase 1 | Oct 23, 2021 | Bio Sidus SA |
| NCT05054387 | Phase 4 | Oct 13, 2021 | Genzyme, Sanofi |
| NCT04143958 | Phase 4 | Dec 2, 2019 | Sanofi |
| NCT02995993 | Phase 1 | Nov 1, 2016 | FGK Clinical Research GmbH, Greenovation Biotech GmbH |
| NCT02795676 | Phase 3 | Jun 1, 2016 | Protalix |
| NCT02930655 | Phase 1 | Feb 1, 2015 | Actelion |
| NCT01653444 | Phase 1 | Nov 1, 2012 | Green Cross Corporation |
| NCT01650779 | Phase 4 | Apr 1, 2012 | Genzyme |
| NCT01483287 | Early Phase 1 (Phase 1) | Nov 1, 2011 | University of Gothenburg |
| NCT01218659 | Phase 3 | Dec 1, 2010 | Amicus Therapeutics |
| NCT01243853 | N/A | Dec 1, 2010 | Verman Oy Ab |
| NCT01595932 | Phase 4 | Jun 1, 2009 | University of Roma La Sapienza |
| NCT00701415 | Phase 3 | Sep 1, 2008 | Genzyme |
| NCT00455104 | Phase 4 | Jan 1, 2007 | Canadian Fabry Research Consortium, Government of Canada, University of Adelaide |
| NCT00230607 | Phase 4 | Aug 1, 2006 | Genzyme |
Organizations
Research & Development (20)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Genzyme | For profit | 13 | 13 | 3 | 1999 |
| Sanofi | For profit | 4 | 2 | 2 | 2019 |
| Bio Sidus SA | For profit | 2 | 2 | 2 | 2021 |
| Actelion | For profit | 1 | 1 | 1 | 2015 |
| Amicus Therapeutics | For profit | 1 | 1 | 1 | 2010 |
| Canadian Fabry Research Consortium | Academic/Hospital | 1 | 1 | 1 | 2007 |
| CRL/Medinet | Academic/Hospital | 1 | 0 | 1 | 2002 |
| FGK Clinical Research GmbH | For profit | 1 | 0 | 1 | 2016 |
| Government of Canada | Government | 1 | 0 | 1 | 2007 |
| Green Cross Corporation | For profit | 1 | 1 | 1 | 2012 |
| Greenovation Biotech GmbH | For profit | 1 | 1 | 1 | 2016 |
| Iowa State University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| ISU Abxis Co., Ltd. | For profit | 1 | 1 | 1 | 2023 |
| Protalix | For profit | 1 | 1 | 1 | 2016 |
| University of Adelaide | Academic/Hospital | 1 | 0 | 1 | 2007 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2001 |
| University of Gothenburg | Academic/Hospital | 1 | 1 | 1 | 2011 |
| University of Paris | Academic/Hospital | 1 | 1 | 1 | 2005 |
| University of Roma La Sapienza | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Verman Oy Ab | For profit | 1 | 1 | 1 | 2010 |