Efficacy and Safety of GNX80 in Patients with Peripheral Arterial Disease and Intermittent Claudication
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Source: Korean Circulation Journal
Institutions: Korea University Anam Hospital, Korea University, The Catholic University of Korea Seoul St. Mary's Hospital, Catholic University of Korea, Daejeon Eulji Medical Center, Eulji University, Hanyang University, Chonnam National University, Pusan National University Hospital, Yonsei University, Yongin Severance Hospital, Kyung Hee University Hospital at Gangdong, Soonchunhyang University, Soonchunhyang University Hospital Cheonan, Eulji University Uijeongbu Eulji Medical Center, Ewha Womans University, Ewha Womans University Seoul Hospital, Kyung Hee University, Kyung Hee University Medical Center, CHA University Bundang Medical Center, CHA University, The Catholic University of Korea St. Vincent's Hospital, Korea University Guro Hospital
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7204270265