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, registered as NCT07269873 on ClinicalTrials.gov, will compare BICX104 administered with or without bupropion to the FDA-approved extended-release naltrexone injection Vivitrol®.
The trial follows completion of required institutional review requirements and is designed to generate pharmacokinetic and tolerability data to support continued development under the FDA's 505(b)(2) regulatory pathway. According to CEO Lourdes Felix, the data generated will help inform subsequent development activities as the company advances this investigational long-acting formulation.
BICX104 is designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure. The clinical trial 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.
The 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 content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
This development comes against the backdrop of significant public health challenges. Methamphetamine use disorder affects millions globally, with the National Survey on Drug Use and Health reporting that more than 16.6 million people used methamphetamine at least once during their lifetime. Opioid use disorder represents another chronic disorder with serious potential consequences including disability, relapses, and death.
Obesity represents another major health concern that this treatment approach may address. The World Health Organization reported in 2024 that one in eight people live with obesity, estimating that by 2035 the global obesity crisis could affect over 4 billion people with healthcare costs upwards of $4 trillion. Obesity-related conditions include stroke, heart disease, cancer, and type 2 diabetes.
BioCorRx's existing treatment portfolio includes the Beat Addiction Recovery program, which combines proprietary Cognitive Behavioral Therapy modules with peer support via mobile app, and the UnCraveRx® Weight Loss Program, a medication-assisted weight loss program that includes access to concierge on-demand wellness specialists. More information on UnCraveRx® is available at https://www.uncraverx.com.
The company also operates through 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 BioCorRx and its subsidiary pipeline, visit https://www.BioCorRx.com.
The advancement of BICX104 represents a potential paradigm shift in treatment delivery for both substance use disorders and weight management. By providing three months of sustained medication delivery through a single implantation procedure, this approach could address compliance challenges that often undermine traditional treatment regimens. The combination with bupropion, commonly used for smoking cessation and depression, suggests a multi-target therapeutic strategy that could enhance efficacy across multiple indications.
For business and technology leaders monitoring healthcare innovation, this development highlights the convergence of pharmaceutical science, medical device technology, and digital health platforms. The integration of long-acting drug delivery systems with behavioral support programs represents a comprehensive approach to chronic condition management that could reduce healthcare system burdens while improving patient outcomes.
