Inventage Lab has secured the final clinical study report (CSR) for the Australian Phase 1 trial of IVL3004, a drug candidate designed to treat addiction with a single monthly dose. The company is accelerating plans for further global clinical development and potential technology licensing.
Inventage Lab announced on the 2nd that its Phase 1 trial of IVL3004, which is being developed to treat alcohol and opioid dependence, confirmed the drug’s safety, tolerability and pharmacokinetic characteristics.
IVL3004 is a naltrexone formulation developed using the company’s IVL-DrugFluidic microfluidics-based platform for long-acting injectable drugs. In the trial, healthy adult men received a single intramuscular injection of either 300 mg or 380 mg of IVL3004. Researchers conducted an exploratory comparison of drug exposure and safety with Vivitrol, an existing treatment.
Both doses of IVL3004 maintained drug exposure for four weeks after administration. In particular, the 380 mg dose maintained an overall drug exposure level, measured by area under the curve (AUC), comparable to Vivitrol while suppressing the rapid release of the drug immediately after injection.
The 300 mg dose, approximately 20% lower than that of the existing treatment, also maintained the target blood concentration. The company said the findings demonstrated the potential to develop an improved drug that could maintain drug exposure while reducing the administered dose.
Safety assessments also showed tolerability comparable to that of the existing treatment. Notably, injection-site reactions lasted an average of 4.3 days with IVL3004, approximately 75% shorter than the 17.2 days reported with Vivitrol.
According to the U.S. Food and Drug Administration (FDA), Vivitrol is an extended-release injectable approved for the treatment of alcohol dependence and the prevention of relapse following opioid detoxification.
Under its U.S. prescribing information, Vivitrol is administered as a 380 mg intramuscular injection every four weeks, or once a month.
According to a separate clinical trial disclosure by Inventage Lab, treatment-emergent adverse events were reported in 42 of the 44 participants who received the study drug. Most were mild.
Inventage Lab plans to use the results from the low-dose arm of the trial to explore the potential for expanding the drug’s indications.
The company is also working to secure intellectual property rights to support global commercialization. It holds a U.S. patent covering the composition and particle characteristics of naltrexone microspheres and received a notice of allowance in September for an additional U.S. patent covering the composition and manufacturing method for an extended-release injectable formulation.
In addition, the IVL3004 development project was selected in August for the 2026 Policy-Designated Global TIPS program, making it eligible to receive up to $4 million in research and development funding over a maximum of four years.
An Inventage Lab representative said, “Based on the clinical study report we have obtained, we plan to consult with the U.S. Food and Drug Administration on the next stages of development and pursue a global Phase 2 trial. We expect to step up discussions on technology licensing and co-development with specialized pharmaceutical companies, building on the product characteristics that differentiate IVL3004 from existing marketed treatments.”