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PRX-115

Phase 2

Gout | Small molecule | Metabolic |Protalix BioTherapeutics, Inc. (DE)|Last Updated: Feb 24, 2026

Target and mechanism

Molecular targeturate
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment214

FDA Designations

No designations recorded

Clinical trial landscape

PRX-115 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT07280156A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)Gout
RECRUITING150 Analytics
PHASE2RECRUITING
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
GoutUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
PRX-115BIOLOGICALintravenous (IV) infusion
Methotrexate (MTX)DRUGOral MTX 15 mg weekly
PRX-115 placeboOTHERintravenous (IV) infusion
Placebo-MethotrexateOTHEROral Placebo-MTX weekly
PlaceboDRUGEscalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
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Frequently asked questions about PRX-115

What is PRX-115 used for in gout?

PRX-115 is an investigational small molecule being developed for the treatment of gout. It is designed to target urate, the underlying cause of the condition. The drug is currently in Phase 2 clinical development and has not yet been approved by regulatory authorities.

What does PRX-115 target?

PRX-115 targets urate, which is the molecular target relevant to gout. By acting on urate, the drug aims to address elevated uric acid levels associated with the condition. This mechanism is central to its potential therapeutic effect in gout patients.

Who makes PRX-115?

PRX-115 is being developed by Protalix BioTherapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol PLX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for gout.

What phase is PRX-115 in?

PRX-115 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The drug is being studied in clinical trials to assess its safety and effectiveness in patients with gout.

What clinical trials is PRX-115 in?

PRX-115 is being evaluated in two clinical trials. The Phase 2 trial, NCT07280156, is recruiting 150 adults with gout and is studying different dosing regimens with and without methotrexate versus placebo. A Phase 1 trial, NCT05745727, has been completed and enrolled 64 volunteers with elevated uric acid levels.