Inventage Lab Advances Alopecia Treatment with Phase 2 Trial Approval in Australia

Inventage Lab has received approval from Australian regulators to initiate a Phase 2 clinical trial for IVL3001, a potential treatment for androgenetic alopecia, commonly known as male pattern baldness. The trial will assess the drug’s efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) properties.

What is IVL3001?

IVL3001 is a once-monthly, long-acting formulation designed to address androgenetic alopecia. The Phase 2 trial will compare IVL3001 to finasteride (Propecia), a currently approved oral medication for hair loss, to evaluate its performance.

Trial Design and Objectives

The randomized, open-label, parallel-design trial aims to enroll 75 participants in Australia. The primary endpoint of the study is the change in blood dihydrotestosterone (DHT) levels on the 113th day of administration. DHT is a hormone linked to hair loss in men with androgenetic alopecia.

The trial will also evaluate the safety and PK/PD characteristics of IVL3001. The expected trial duration is approximately 12 months, with an anticipated completion date around February 24, 2027.

Collaboration and Future Plans

Inventage Lab is collaborating with Daewoong Pharmaceutical to conduct the clinical trials. The companies are also in discussions with other international pharmaceutical firms regarding potential technology transfer agreements. They plan to submit an Investigational New Drug (IND) application to the Korean Ministry of Food and Drug Safety in the first half of next year and conduct clinical trials at four sites, both domestically and internationally.

Inventage Lab Pipeline

IVL3001 is one of several drug candidates in Inventage Lab’s pipeline, which utilizes a microfluidics-based drug delivery system. Other programs include treatments for Alzheimer’s disease, rheumatoid arthritis, multiple sclerosis, and various other conditions.

Inventage Lab aims to objectively verify the efficacy and safety of IVL3001 and advance its potential for commercialization.