[Edaily Reporter NA EUN-KYUNG ] Inventage Lab Inc.(389470), a drug delivery platform company, has received a decision granting an additional patent in the U.S. for IVL3004, a long-acting injectable drug for the treatment of drug addiction currently under development.

Inventage Lab Inc. announced on the 21st that it had received a registration decision from the U.S. Patent and Trademark Office (USPTO) for a patent titled “Sustained-release injectable composition containing naltrexone and method for its manufacture.”

IVL3004 is a long-acting, once-monthly injection with naltrexone as its active ingredient. It is being developed for the treatment of alcohol and drug dependence. This patent covers a microparticle composition with consistent pharmacokinetic properties and a uniform particle size distribution, as well as the method for its manufacture. The patent protects the formulation characteristics and manufacturing technology that control the rapid initial release of the drug while ensuring its sustained release over a one-month period.

The patent claims also specify a composition containing more than 240 mg but less than 310 mg of naltrexone. This dosage range differs from U.S. Patent No. 7,919,499, which covers Alchemy’s long-acting naltrexone treatment “Vivitrol” and includes dosage ranges of approximately 190–240 mg and approximately 310–480 mg within its scope of protection.

The currently approved dosage of Vivitrol sold in the United States is 380 mg, administered via intramuscular injection once every four weeks or once a month. In the United States, it is approved for the treatment of alcohol dependence and for preventing relapse into opioid dependence following opioid detoxification.

Inventage Lab Inc. explained that the scope of this patent includes not only specific dosages but also certain pharmacokinetic (PK) characteristics, the particle size distribution of the microparticles, sustained-release properties, and the manufacturing method.

The company had previously registered U.S. Patent No. 11,730,731 for a naltrexone microparticle composition with specific particle sizes and biodegradable polymer characteristics. While the existing patent focuses on the composition and particle characteristics of the microparticles, this new patent additionally protects pharmacokinetic performance, particle size distribution, dosage range, and manufacturing methods. As a result, IVL3004 is now protected by multiple patents covering everything from product composition to performance and the production process.

IVL3004 is being developed with the goal of maintaining effective blood concentrations for four weeks at a lower dose than Vivitrol. In a previously conducted Phase 1 clinical trial, Vivitrol 380 mg was compared with IVL3004 300 mg and 380 mg in healthy adults. According to the clinical trial design presented at the 2026 American Academy of Neurology (AAN) meeting, the study compared pharmacokinetics and safety in 34 participants.

In the Phase 1 clinical trial results released by Inventage Lab Inc. last year, the duration of injection site adverse events in the IVL3004 groups was 3.8 days and 4.9 days, respectively. In the Vivitrol group, it was 18.2 days. No serious adverse events, deaths, or cases of treatment discontinuation due to adverse events were reported. However, as these are preliminary clinical results, further confirmation through subsequent clinical trials is necessary.

The company plans to utilize this patent in its U.S. clinical development and in future global technology transfer and joint development processes. It intends to secure the scope of rights for IVL3004 during future partnering efforts by protecting not only the product’s formulation but also the manufacturing methods necessary for commercial production through patents.

The company also plans to utilize the clinical and regulatory data obtained in the U.S. for domestic development. It envisions expanding the scope of application to include domestic addiction treatment facilities and the public healthcare sector in the future.

The IVL3004 development project was selected last August for the “2026 Policy-Designated Global TIPS Program for Technology Development Linked to Investment and Financing.” Based on this, Inventage Lab Inc. plans to conduct regulatory consultations with the U.S. Food and Drug Administration (FDA) and proceed with the development of a U.S. Phase 2 clinical trial.

An Inventage Lab Inc. official stated, “This U.S. patent registration decision is significant not only in protecting the technology behind IVL3004 but also in securing the technical and business foundation necessary to develop an improved new drug in the U.S. market and pursue global partnerships.” The official added, “We will leverage the results of our U.S. clinical development to secure domestic approval and enter the public healthcare market, thereby providing a new treatment option for drug addiction.”