- Long-acting injectable candidate 'IVL3004' shows a strong safety and tolerability profile
- Injection site reactions last 3.8-4.9 days, significantly shorter than Vivitrol's 18.2 days
[by Ji, Yong Jun] Inventage Lab announced topline results from its Phase 1 clinical trial of ‘IVL3004 (development code),’ a long-acting candidate for the treatment of drug addiction. According to the company, the drug demonstrated a clear differentiation advantage over Vivitrol, a marketed therapy containing the same active ingredient (naltrexone).
Inventage Lab announced on September 10 topline results from its Phase 1 clinical trial of IVL3004 in Australia, conducted in healthy adult participants. The study compared a single intramuscular injection of IVL3004 with a single intramuscular injection of Vivitrol, the control 강원 랜드 바카라. Designed as an open-label, exploratory, fixed-sequence trial, the study consisted of a single-dose pharmacokinetic assessment with an escalating pharmacokinetic component.
The primary endpoints included the evaluation of adverse events post-administration, changes in baseline vital signs, electrocardiograms, physical examinations, injection site assessments, and clinical 강원 랜드 바카라oratory parameters, along with individual and mean plasma concentration-time profiles.
According to Inventage 강원 랜드 바카라, IVL3004 demonstrated an overall favorable safety and tolerability profile, with adverse events (AEs) reported as mild. Among the 34 participants, 33 (97.1%) experienced treatment-emergent adverse events (TEAEs). These were observed in all subjects receiving IVL3004 (300 mg and 380 mg) and in 90.0% (9 of 10) of those administered Vivitrol.
The most frequently reported adverse event in both the IVL3004 and Vivitrol groups was injection site pain (88.2%). Other commonly observed events included nausea (29.4%), exertional rhabdomyolysis and depression (17.6% each), fatigue (14.7%), and decreased appetite and headache (11.8% each).
Clinical findings demonstrated that the duration of injection-site adverse reactions was markedly shorter in the IVL3004 groups, 3.8 days for the 300 mg cohort and 4.9 days for the 380 mg cohort, compared with 18.2 days for Vivitrol. This outcome significantly improved patient safety and administration convenience. Moreover, no serious adverse events (SAEs), deaths, or treatment discontinuations were reported.
Pharmacokinetic (PK) analysis also showed that IVL3004 exhibited sustained-release properties and maintained stable blood concentrations within the therapeutic range. IVL3004 380 mg dose, the same as the reference 강원 랜드 바카라 Vivitrol, IVL3004 demonstrated a notably more stable pharmacokinetic profile, consistently remaining within the effective concentration range.
Notably, even in the low-dose IVL3004 300 mg group, a 30% reduction compared with the reference 강원 랜드 바카라 and 강원 랜드 바카라 absorption comparable to Vivitrol were sustained for one month. The company further explained that IVL3004 demonstrated an excellent pharmacokinetic profile, characterized by the absence of initial 강원 랜드 바카라 over-release and adequate systemic exposure, thereby underscoring its potential to simultaneously improve patient safety and tolerability.
Inventage Lab has been developing IVL3004 since 2020 under the Ministry of Health and Welfare's ‘Biohealth Investment Infrastructure-Linked R&D’ program. IVL3004 is currently the only long-acting 강원 랜드 바카라 addiction treatment in development in Korea. The company emphasized that the candidate holds strategic significance beyond competing with global treatments, highlighting its potential to address national public health needs.
The company plans to present its research findings and policy implications for IVL3004 at a seminar titled ‘Current Status of 강원 랜드 바카라 Addiction Treatment and the Need for Nationally Led Treatments" at the National Assembly on September 17. Furthermore, building on these clinical results, Inventage Lab is actively preparing out-licensing (L/O) collaborations with global pharmaceutical companies, with the goal of establishing a competitive 강원 랜드 바카라 addiction treatment portfolio both in Korea and internationally. The global market for 강원 랜드 바카라 addiction treatments was valued at USD 20 billion in 2024 and is projected to grow at a CAGR of 7.5%, reaching USD 35.6 billion by 2034.
"The Phase 1 clinical trial results for IVL3004 demonstrate that our 강원 랜드 바카라 delivery system (DDS) platform technology provides competitive differentiation from global standard treatments in real-world patient care settings," an Inventage Lab official emphasized.