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PRX-115

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment214
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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)PHASE2 RECRUITING 150Dec 1, 2025Jun 1, 2028Feb 24, 2026 -
NCT05745727A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid LevelsPHASE1 COMPLETED 64Mar 1, 2023Feb 1, 2025Feb 10, 2025 -
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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
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07280156studyFirstPostDate: changed