A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Efficacy, Safety, and Dosing Regimen Selection of Multiple Intravenous Infusions of PRX-115 With and Without Methotrexate Versus Placebo in Adult Patients With Gout (RELEASE)
Latest Information Update: 16 Dec 2025
At a glance
- Drugs Methotrexate (Primary) ; PRX-115 (Primary)
- Indications Gout
- Focus Therapeutic Use
- Acronyms RELEASE
- Sponsors Protalix Biotherapeutics
Most Recent Events
- 14 Dec 2025 Status changed from planning to not yet recruiting.
- 13 Nov 2025 According to Protalix BioTherapeutics media release, in October 2025, we submitted an Investigational New Drug (IND) to the US Food and Drug Administration in connection with our planned phase 2 clinical trial of PRX-115 for the potential treatment of uncontrolled gout.
- 13 Nov 2025 According to Protalix BioTherapeutics media release, company is planning to initiate the trial later this year.