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Pegunigalsidase alfa · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Pegunigalsidase alfa | BIOLOGICAL | Pegunigalsidase alfa 2 mg/kg every 4 weeks |
Pegunigalsidase alfa is an investigational therapy being developed for Fabry Disease, a rare genetic disorder. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is designed to address the underlying enzyme deficiency in patients with this condition.
Pegunigalsidase alfa is being developed by Protalix BioTherapeutics, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol PLX. The company is focused on developing therapies for rare diseases, with Pegunigalsidase alfa being one of its key pipeline assets.
Pegunigalsidase alfa is in Phase 3 clinical development for Fabry Disease. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 3 trial has been completed, and the data will be used to support potential regulatory submissions.
Pegunigalsidase alfa has been studied in a Phase 3 clinical trial with the identifier NCT03180840. This trial, titled 'Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks,' enrolled 30 patients and has been completed. The study was uncontrolled and not randomized or double-blinded.
Yes, Pegunigalsidase alfa is also known as PRX-102. In clinical trials, the drug is referred to by this alternative name, as seen in the Phase 3 study NCT03180840. Both names refer to the same investigational therapy for Fabry Disease.