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PRX-115

Phase 2

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

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Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment214
FDA Designations
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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)
Gout
NCT07280156150
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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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Competitive Landscape -Gout 5 trials
CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN1PHASE3Pegloticase, Methotrexate
Protalix BioTherapeutics, Inc. (DE)PLX1PHASE2PRX-115, Methotrexate
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE1NNC4004-0002
TJ Biopharma Co., Ltd.IMAB1PHASE2Plonmarlimab, Compound betamethasone
Sunshine Biopharma IncorporatedSBFM1PHASE1Pegylated Recombinant Candida Utilis Uricase
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07280156studyFirstPostDate: changed