BioCorRx Inc. announced that its majority-owned subsidiary, BioCorRx Pharmaceuticals, Inc., has initiated a Phase 1 clinical study evaluating BICX104, an investigational long-acting subcutaneous naltrexone implant. The study, which compares BICX104 administered with or without bupropion to the FDA-approved extended-release naltrexone injection Vivitrol®, is now underway following completion of required institutional review requirements.
The clinical trial, registered under ClinicalTrials.gov Identifier: NCT07269873, is designed to generate pharmacokinetic and tolerability data to support continued development under the FDA's 505(b)(2) regulatory pathway. This study matters because it addresses significant public health challenges: substance use disorders and obesity. According to the 2022 National Survey on Drug Use and Health, more than 16.6 million people used methamphetamine at least once during their lifetime, while the World Health Organization reported in 2024 that one in eight people worldwide live with obesity.
BICX104 is designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure. This extended duration could potentially improve treatment adherence compared to existing options, which is crucial for chronic conditions like opioid use disorder (OUD) and methamphetamine use disorder (MUD). OUD is typically a chronic and relapsing illness associated with significantly increased rates of morbidity and mortality, while MUD side effects include severe dental problems, memory loss, aggression, psychotic behavior, and cardiovascular damage.
The study will enroll participants into four sequential cohorts, with participants completing an 84-day treatment period followed by an 84-day follow-up period and a 28-day post-treatment observation phase. Study assessments include pharmacokinetic sampling, monitoring of adverse events, laboratory evaluations, vital signs, and other tolerability measures. Outcomes from the investigational arms will be compared to those from participants receiving Vivitrol®.
Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health under Award Number U01DA059994. The potential impact of this research extends beyond addiction treatment, as the combination with bupropion could also address weight management through the UnCraveRx® Weight Loss Program. Obesity affects an estimated 1 billion people worldwide and could rise to over 4 billion people by 2035, with healthcare costs potentially reaching $4 trillion for obesity-related conditions including stroke, heart disease, cancer, and type 2 diabetes.
BioCorRx also operates through its subsidiary, BioCorRx Pharmaceuticals Inc., which focuses on pharmaceutical commercialization and development, including LUCEMYRA® (lofexidine), an FDA-approved medication indicated to mitigate opioid withdrawal symptoms in adults. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com. The company's Beat Addiction Recovery program typically includes proprietary Cognitive Behavioral Therapy modules along with peer support via mobile app, while the UnCraveRx® Weight Loss Program includes access to concierge on-demand wellness specialists. More information on UnCraveRx® is available at www.uncraverx.com.
