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PRX-102

Phase 3

Fabry Disease | Small molecule | Rare Disease |Protalix BioTherapeutics, Inc. (DE)|Last Updated: Sep 12, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials4
Total Enrollment133

FDA Designations

No designations recorded

Clinical trial landscape

PRX-102 · 4 trials · 1 indication

Phase 3 2Phase 1/2 2
NCT03018730Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)Fabry Disease
COMPLETED22 Analytics
NCT02795676Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal FunctionFabry Disease
COMPLETED78 Analytics
PHASE3COMPLETED
Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)
Fabry DiseaseUnlock trial analytics
PHASE3COMPLETED
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
Fabry DiseaseUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
PRX-102 (pegunigalsidase alfa)BIOLOGICALPRX-102 1 mg/kg every 2 weeks
agalsidase betaBIOLOGICALagalsidase beta 1 mg/kg every 2 weeks
PRX-102DRUG -
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Frequently asked questions about PRX-102

What is PRX-102 used for?

PRX-102 is an investigational drug being developed for the treatment of 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 being studied to evaluate its safety and efficacy in patients with this condition.

Who makes PRX-102?

PRX-102 is being developed by Protalix BioTherapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol PLX. Protalix is focused on developing therapies for rare diseases, and PRX-102 is one of its key investigational candidates for Fabry disease.

What phase is PRX-102 in?

PRX-102 is currently in Phase 3 clinical development for Fabry disease. It has completed four clinical trials, including two Phase 3 studies. The drug is still investigational and has not received FDA approval. Its safety and efficacy are being evaluated in patients with Fabry disease.

What clinical trials is PRX-102 in?

PRX-102 has completed four clinical trials for Fabry disease. These include NCT01678898, a dose-ranging study; NCT01981720, an extension study; NCT02795676, a Phase 3 study comparing PRX-102 to agalsidase beta on renal function; and NCT03018730, a Phase 3 study in patients currently treated with REPLAGAL (agalsidase alfa).

Is PRX-102 the same as REPLAGAL?

No, PRX-102 is not the same as REPLAGAL (agalsidase alfa). PRX-102 is a separate investigational drug being developed by Protalix BioTherapeutics. One of its Phase 3 trials (NCT03018730) specifically studied PRX-102 in patients with Fabry disease who were already being treated with REPLAGAL.