Clinical Study Evaluating a Long-Acting Naltrexone Implant Under the FDA’s 505(b)(2) Pathway
ANAHEIM, CA - January 14, 2026 (NEWMEDIAWIRE) - BioCorRx Inc. (OTCID: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today 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, administered with or without bupropion, compared to the FDA-approved extended-release naltrexone injection Vivitrol®.
The study: Safety and Pharmacokinetics Study of BICX104 With or Without Bupropion Compared to Vivitrol (ClinicalTrials.gov Identifier: NCT07269873) is now underway following completion of required institutional review requirements. The trial is designed to generate pharmacokinetic and tolerability data to support the continued development of BICX104 under the FDA’s 505(b)(2) regulatory pathway.
“This study is intended to support the continued development of BICX104 by generating pharmacokinetic and tolerability data,” said Lourdes Felix, CEO, BioCorRx Inc. “The data generated will help inform subsequent development activities as we advance this investigational long-acting formulation.”
The clinical trial will enroll participants into four sequential cohorts and evaluate BICX104 administered alone and in combination with bupropion. BICX104 is designed to provide sustained plasma concentrations of naltrexone for approximately three months following a minimally invasive subcutaneous implantation procedure.
Participants will complete 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®, an approved extended-release naltrexone product.
About BioCorRx Inc.
BioCorRx Inc. (OTCID: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication-assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts, and personal support from behavioral experts, please visit www.uncraverx.com for more information on UnCraveRx®.
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 - and the development of BICX104, an investigational implantable naltrexone pellet program. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com.
About BICX104
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.
About MUD
Research has shown that methamphetamine is a highly addictive stimulant and one of the most misused stimulant drugs in the world. Some of the side effects of MUD are severe dental problems, memory loss, aggression, psychotic behavior, and damage to the cardiovascular system. In 2022 the National Survey on Drug Use and Health reported that more than 16.6 million people used methamphetamine at least once during their lifetime.
About OUD
OUD is a chronic disorder, with serious potential consequences including disability, relapses, and death. Opioids, used medically for pain relief, have analgesic and central nervous system depressant effects as well as the potential to cause euphoria with an overpowering desire to use opioids despite the consequences. OUD can involve misuse of prescribed opioid medications, use of diverted opioid medications or illicitly obtained heroin. OUD is typically a chronic and relapsing illness, that is associated with significantly increased rates of morbidity and mortality.
About Obesity
It is estimated that 1 billion people worldwide are obese. In 2024 the World Health Organization reported that one in eight people live with obesity and stressed the importance and need to curb the obesity epidemic with new interventions. It is estimated that by 2035 the global obesity crisis could rise to over 4 billion people. Affecting healthcare costs upwards of $4 trillion with obesity-related conditions including; stroke, heart disease, cancer, and type 2 diabetes.
About LUCEMYRA® (lofexidine)
LUCEMYRA® (lofexidine), an oral tablet, is a central alpha 2-adrenergic agonist that reduces the release of norepinephrine to suppress the neurochemical surge that produces opioid withdrawal. It is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. In clinical trials, LUCEMYRA® reduced the severity of withdrawal symptoms compared to placebo, as reported by patients experiencing opioid withdrawal. LUCEMYRA® is administered A orally for up to 14 days, with dosing guided by symptoms. LUCEMYRA® should be discontinued with gradual dose reduction over two to four days. The most common adverse reactions are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown. risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
Important Safety Information
What is LUCEMYRA?
LUCEMYRA is a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal that may happen when you stop taking an opioid suddenly. LUCEMYRA will not completely prevent the symptoms of opioid withdrawal and is not a treatment for opioid use disorder.
Important Safety Information
LUCEMYRA can cause serious side effects, including low blood pressure, slow heart rate, and fainting. Watch for symptoms of low blood pressure or heart rate, including dizziness, lightheadedness, or feeling faint at rest or when quickly standing up; if you experience these symptoms, call your healthcare provider right away and do not take your next dose of LUCEMYRA until you have talked to your healthcare provider. Avoid becoming dehydrated or overheated and be careful not to stand up too suddenly from lying or sitting, as these may increase your risk of low blood pressure and fainting. When your treatment is complete, you will need to stop taking LUCEMYRA gradually, or your blood pressure could increase. After a period of not using opioid drugs, you can become more sensitive to the effects of opioids if you start using them again. This may increase your risk of overdose and death. Before taking LUCEMYRA, tell your healthcare provider about all your medical conditions, including if you have low blood pressure, slow heart rate, any heart problems including history of heart attack or a condition called long QT syndrome, liver or kidney problems, or if you drink alcohol. Tell your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding; it is not known if LUCEMYRA can harm your unborn baby or whether LUCEMYRA passes into your breast milk. Especially tell your healthcare provider if you take benzodiazepines, barbiturates, tranquilizers, or sleeping pills, as taking these with LUCEMYRA can cause serious side effects. The most common side effects of LUCEMYRA include low blood pressure or symptoms of low blood pressure such as lightheadedness, slow heart rate, dizziness, sleepiness, and dry mouth. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact BioCorRx Pharmaceuticals Inc. at 1-833-LUCEMYRA. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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IBioCorRx Inc.
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