Efficacy and Safety of GNX80 in Patients with Peripheral Arterial Disease and Intermittent Claudication

BACKGROUND AND OBJECTIVES: extract (GbE) has been investigated for the treatment of IC, its clinical efficacy remains controversial. This study aimed to evaluate the efficacy and safety of high-dose, long-term GbE therapy in patients with PAD and IC. METHODS: This randomized, double-blind, placebo-controlled, multicenter phase 4 trial enrolled patients with stable PAD and Fontaine stage IIb IC from 15 hospitals in South Korea. Participants were randomly assigned at a ratio of 1:1 to receive 80 mg of GbE (GNX80) twice daily or a placebo twice daily for 24 weeks. The primary endpoint was changes in the maximal walking distance (MWD) assessed using standardized treadmill testing after 24 weeks. RESULTS: At 24 weeks, in the full analysis set (FAS), GNX80 treatment was associated with a numerically greater improvement in MWD than placebo that did not reach statistical significance (58.95±129.79 vs. 12.09±131.33 m; p=0.095); a significant difference was observed in the pre-specified per-protocol analysis (p=0.041). The overall incidence of adverse events was similar between the GbE and placebo groups, and no new safety signals or treatment-discontinuing adverse events were observed. CONCLUSIONS: For patients with stable PAD and IC, GNX80 was associated with a numerically greater improvement in MWD compared with placebo, although statistical significance was not achieved in the primary FAS analysis. Further randomized trials are warranted to determine whether GNX80 improves functional capacity in this patient population. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05400395.