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Also known as PRX-102, PRX-102 (pegunigalsidase alfa), Pegunigalsidase alfa
Pegunigalsidase alfa (PRX-102) · 5 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| Pegunigalsidase alfa | BIOLOGICAL | Pegunigalsidase alfa 2 mg/kg every 4 weeks |
| PRX-102 (pegunigalsidase alfa) | BIOLOGICAL | PRX-102 1 mg/kg every 2 weeks |
| agalsidase beta | BIOLOGICAL | agalsidase beta 1 mg/kg every 2 weeks |
| PRX-102 | DRUG | - |
Pegunigalsidase alfa is being developed for the treatment of Fabry disease, a rare inherited disorder. It is an investigational therapy studied in patients with Fabry disease, including those previously treated with other enzyme replacement therapies. It has not been approved for commercial use.
Pegunigalsidase alfa is developed by Protalix BioTherapeutics, Inc., which trades under the ticker PLX. The company is advancing the candidate as PRX-102 for Fabry disease.
Pegunigalsidase alfa is in Phase 3 clinical development for Fabry disease. Five trials have been completed, including Phase 3 studies, and no trials are currently active. It remains an investigational drug and is not approved.
Completed trials include NCT03180840, a Phase 3 study of intravenous dosing every four weeks; NCT03018730, a Phase 3 study in patients previously treated with agalsidase alfa; NCT02795676, a Phase 3 comparison with agalsidase beta on renal function; and NCT01981720, a Phase 1/2 extension study.
Yes, pegunigalsidase alfa and PRX-102 refer to the same investigational drug candidate for Fabry disease. PRX-102 is the development code used by Protalix BioTherapeutics, while pegunigalsidase alfa is the drug's scientific name.