Drugs / agalsidase beta
agalsidase beta
also known as
Fabrazyme · GZ419828 · .alpha.--galactosidase · Agalsidasa beta · Agalsidase beta (genetical recombination) · agalsidase beta; Fabrazyme · Fabagal
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FABRAZYME | — | 2006-09-29 – 2021-03-11 | fda.gov ↗ |
| Approved | US (FDA) | FABRAZYME | — | 2003-04-24 | fda.gov ↗ |
| Approved | EU (EMA) | Fabrazyme | — | 2001-08-03 | europa.eu ↗ |
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT01196871 | Feb 2011 → Oct 2012 | Fabry disease | Amicus Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00196716 | Jun 2003 → Apr 2006 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00837824 | Dec 2002 → Aug 2003 | Fabry disease, chronic kidney disease | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 2 | NCT00074958 | Oct 2002 → May 2005 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06081062 | Apr 2023 → Jun 2025 overdue | Fabry disease | ISU Abxis Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05843916 | Dec 2022 → Sep 2024 | Fabry disease | Bio Sidus SA | Completed | No outcome recorded |
| Phase 3 | NCT00701415 | Sep 2008 → Jun 2015 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00074971 | Oct 1999 → Dec 2004 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT06019728 | Nov 2023 → Oct 2024 | Fabry disease | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT05054387 | Oct 2021 → Mar 2023 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT04143958 | Sep 2020 → Nov 2023 | Fabry disease | Sanofi | Withdrawn | No outcome recorded |
| Phase 4 | NCT01650779 | Apr 2012 → Mar 2013 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00230607 | May 2006 → Feb 2024 | Fabry disease | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 4 | NCT00312767 | Apr 2006 → ? | Fabry disease | Genzyme, a Sanofi Company | Withdrawn | No outcome recorded |
| Phase 4 | NCT00140621 | Jul 2005 → Aug 2012 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT00487630 | Jun 2005 → Jun 2009 | Fabry disease | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 4 | NCT00081497 | Jan 2004 → Sep 2005 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05343715 Comparator | Oct 2021 → Mar 2022 | Fabry disease | Bio Sidus SA | Completed | No outcome recorded |
| Phase 1 | NCT02930655 Background | Feb 2015 → Feb 2016 | Fabry disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05280548 Comparator | May 2022 → May 2026 overdue | Fabry disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02795676 Comparator | Jun 2016 → Oct 2021 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 3 | NCT01218659 Comparator | Sep 2011 → May 2014 | Fabry disease | Amicus Therapeutics | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01997489 Background | Sep 2001 → Sep 2013 | Fabry disease | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 4 | NCT00074984 Comparator | Feb 2001 → Jan 2004 | Fabry disease | Genzyme, a Sanofi Company | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | agalsidase beta | “OBJECTIVE: To evaluate the safety and explore the efficacy of enzyme replacement therapy with agalsidase beta (recombinant human alpha-galactosidase A; Fabrazyme [Genzyme...” PMID 18346516 ↗ Dec 200722“Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (FABRAZYME).” NCT00487630 ↗ “Fabrazyme (agalsidase beta) 1 mg/kg” NCT05343715 ↗ “Fabrazyme (agalsidase beta)” NCT00837824 ↗ “Fabrazyme (agalsidase beta)” NCT00312767 ↗ “Fabrazyme (agalsidase beta)” NCT00074971 ↗ “Fabrazyme (agalsidase beta)” NCT00196716 ↗ “agalsidase beta; Fabrazyme” NCT01218659 ↗ |
| Known as | .alpha.--galactosidase | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108888 ↗ |
| Known as | Agalsidasa beta | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108888 ↗ |
| Known as | Agalsidase beta (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108888 ↗ |
| Known as | agalsidase beta; Fabrazyme | “agalsidase beta; Fabrazyme” NCT01218659 ↗ |
| Known as | Fabagal | “Fabagal® (Agalsidase beta)” NCT06081062 ↗ |
| Known as | Fabrazyme | “Clearance of Gb3 and stabilization of renal function has been demonstrated in male patients treated with agalsidase beta (FABRAZYME).” NCT00487630 ↗ |
| Known as | GZ419828 | “Drug: agalsidase beta (GZ419828)” NCT04143958 ↗1“Agalsidase beta (GZ419828)” NCT05280548 ↗ |
| Action | Restore | “enzyme replacement therapy” PMID 18346516 ↗ Dec 2007 |
| Modality | Protein / enzyme biologic | “enzyme replacement therapy with agalsidase beta (recombinant human alpha-galactosidase A; Fabrazyme [Genzyme Corporation, Cambridge, MA])” PMID 18346516 ↗ Dec 2007 |
| Route | Intravenous | “agalsidase beta (1 mg/kg) was infused intravenously every 2 weeks” PMID 18346516 ↗ Dec 2007 |