Drugs / Replagal
Replagal
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Replagal | — | 2001-08-03 | europa.eu ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00357786 | Oct 2003 → Dec 2008 | Fabry disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT01304277 | Nov 2011 → Dec 2012 | Fabry disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01363492 | May 2011 → Apr 2013 | Fabry disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01196871 | Feb 2011 → Oct 2012 | Fabry disease | Amicus Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00084084 | Jun 2004 → Jun 2011 | Fabry disease | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00075244 | Jan 2004 → Nov 2005 | Fabry disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00071877 | Oct 2003 → Jun 2005 | Fabry disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00068107 | Sep 2003 → Dec 2013 | Fabry disease | Baylor Research Institute | Completed | Met primary |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT04974749 | May 2022 → Jan 2024 | Fabry disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04840667 | Dec 2021 → Dec 2022 | Fabry disease | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01298141 | Aug 2011 → Sep 2017 | Fabry disease | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01124643 | Apr 2010 → Jul 2013 | Fabry disease | Shire | Completed | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT05067868 | Nov 2022 → Oct 2027 expected | Fabry disease | Shire | Recruiting | No outcome recorded |
| Phase 4 | NCT00097890 | Nov 2004 → Dec 2005 | Fabry disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01031173 | — | Fabry disease | Shire | No longer available | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT02930655 Background | Feb 2015 → Feb 2016 | Fabry disease | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05280548 Comparator | May 2022 → May 2026 overdue | Fabry disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01218659 Comparator | Sep 2011 → May 2014 | Fabry disease | Amicus Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00864851 Comparator | Dec 2008 → Jun 2012 | Fabry disease | Shire | Completed | No outcome recorded |
| Phase 4 | NCT04143958 Comparator | Sep 2020 → Nov 2023 | Fabry disease | Sanofi | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01997489 Background | Sep 2001 → Sep 2013 | Fabry disease | Rigshospitalet, Denmark | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-10-05 | Protalix | Results Protalix BioTherapeutics Presents Positive Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry Disease at the 1st Canadian Symposium on Lysosomal Diseases 2018 protalix.com ↗
A deterioration trend in patients’ kidney function on agalsidase alfa (Replagal®) was reversed to an improvement trend when switched to pegunigalsidase alfa (PRX-102) |
All press releases naming this drug 1 release
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Replagal | “Replagal (agalsidase alfa) at a dose of 0.2 mg/kg of body weight administered every 2 weeks” NCT00357786 ↗ |
| Known as | Agalsidase Alfa | “A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal® (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease” NCT01298141 ↗12“Replagal (Agalsidase Alfa)” NCT00097890 ↗ “Replagal (agalsidase alfa)” NCT00075244 ↗ “agalsidase alfa; Replagal” NCT01218659 ↗ |
| Known as | agalsidase alfa; Replagal | “agalsidase alfa; Replagal” NCT01218659 ↗ |
| Action | Restore | “enzyme replacement therapy with Replagal” NCT00075244 ↗ |
| Modality | Protein / enzyme biologic | “Replagal is a genetically engineered form of Alpha-galactosidase A, an enzyme” NCT00068107 ↗ |
| Route | Intravenous | “Participants will receive an intravenous infusion of Replagal” NCT00071877 ↗ |