pegunigalsidase alfa
Trade name: Elfabrio
Recombinant proteinapprovedFast Track FDA
Approved
May 9, 2023
Clinical trial activity
12 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
9
Phase 3
8
Phase 4
0
Earliest trial started Oct 1, 2012 (NCT01678898)
Timeline
Indications
Approved for
Studied for
Mechanism of action
- GlobotriosylceramideHYDROLYTIC ENZYME
Globotriosylceramide hydrolytic enzyme
- Alpha-galactosidase ASupplementation
GLA supplementation
Approval history
- approvedPriority reviewFast trackMay 9, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4297801 ↗
Also known as
- pegunigalsidase alfa
- pegunigalsidase alfa
- prx-102
- prx-102
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06328608 | Phase 2/Phase 3 (Phase 3) | Oct 31, 2024 | Chiesi, ICON |
| NCT05710692 | Phase 2/Phase 3 (Phase 3) | Aug 1, 2023 | Chiesi, ICON |
| NCT03614234 | Phase 3 | Nov 30, 2018 | Protalix |
| NCT03566017 | Phase 3 | Sep 30, 2018 | Protalix |
| NCT03180840 | Phase 3 | Dec 1, 2017 | Protalix |
| NCT02921620 | Phase 3 | Jul 1, 2017 | Protalix |
| NCT03018730 | Phase 3 | Feb 23, 2017 | Protalix |
| NCT02795676 | Phase 3 | Jun 1, 2016 | Protalix |
| NCT01981720 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2013 | Protalix |
| NCT01769001 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2013 | Protalix |
| NCT01678898 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2012 | Protalix |
| NCT04552691 | N/A | — | Chiesi, Covance, Protalix |
Showing 12 of 12 trials
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