Drugs / pegunigalsidase alfa
pegunigalsidase alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Elfabrio | — | 2023-05-04 | europa.eu ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01981720 | Jan 2014 → Aug 2020 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 1/2 | NCT01678898 | Oct 2012 → Mar 2016 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06328608 | Jul 2025 → Oct 2028 expected | Fabry disease | Chiesi Farmaceutici S.p.A. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05710692 | Aug 2023 → Oct 2027 expected | Fabry disease | Chiesi Farmaceutici S.p.A. | Recruiting | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT03614234 | Nov 2018 → Apr 2026 | Fabry disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT03566017 | Sep 2018 → Jan 2025 | Fabry disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT03180840 | Jul 2017 → Aug 2020 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 3 | NCT02921620 | Jul 2017 → Jul 2018 | Fabry disease | Protalix | Withdrawn | No outcome recorded |
| Phase 3 | NCT03018730 | May 2017 → Dec 2019 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase 3 | NCT02795676 | Jun 2016 → Oct 2021 | Fabry disease | Protalix | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04552691 | — | Fabry disease | Chiesi Farmaceutici S.p.A. | Approved for marketing | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pegunigalsidase alfa | “A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease (RISE)” NCT05710692 ↗6“This study aims to learn how safe pegunigalsidase alfa (PRX-102 for short) is and how it works at treating Fabry disease in children and adolescents.” NCT06328608 ↗ |
| Known as | Elfabrio | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297801 ↗ |
| Known as | Pegunigalsidasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297801 ↗ |
| Known as | Pegunigalsidase alfa-iwxj | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297801 ↗ |
| Known as | PRX-102 | “pegunigalsidase alfa (PRX-102) is a drug made using genetic engineering techniques and manufactured using cultured tobacco cells.” NCT05710692 ↗6“This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa).” NCT03018730 ↗ |
| Action | Restore | “developed as enzyme replacement therapy (ERT) for Fabry disease (FD)” PMID 30834538 ↗ Apr 2019 |
| Modality | Protein / enzyme biologic | “PRX-102, an enzyme being developed as a long-term enzyme replacement therapy” NCT01678898 ↗ |
| Route | Intravenous | “receive PRX-102 as an intravenous infusion every 2 weeks for 12 weeks (3 months)” NCT01678898 ↗ |