Daewoong Receives Approval for Phase 1 Clinical Trial Plan of Hair Loss Treatment Injection 'IVL3001' in Australia

Daewoong Pharmaceutical Headquarters Exterior (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Lee Chun-hee] Daewoong Pharmaceutical's long-acting injectable hair loss treatment 'IVL3001' has received approval for a Phase 1 clinical trial plan in Australia.

Daewoong Pharmaceutical announced on the 27th that its long-acting injectable hair loss treatment 'IVL3001' has been approved for a Phase 1 clinical trial plan (IND) by the Australian Therapeutic Goods Administration (TGA).

Through this clinical trial, Daewoong Pharmaceutical plans to demonstrate the efficacy of IVL3001 based on superior pharmacokinetics and biochemical markers compared to oral medications. In previous efficacy tests, IVL3001 proved to have a superior hair loss treatment effect even at lower doses compared to oral drugs.

If this clinical trial is successfully completed, the development of a hair loss treatment injectable that only needs to be administered once every 1 to 3 months without daily medication is expected to become tangible. Especially since medication adherence, which requires patients to take a prescribed amount very consistently under a doctor's guidance, is crucial when taking hair loss treatments, administering a long-acting injectable can provide convenience along with stable efficacy. Additionally, since the injection is administered at a hospital visit, the risks of misuse and side effects are also reduced.

This clinical trial is a result of the tripartite business agreement signed in June between Daewoong Pharmaceutical, Inventage Lab, and Withus Pharmaceutical for the development, production, and sales of a long-acting injectable hair loss treatment. The three companies are jointly developing and commercializing the product with a goal of domestic release in 2023. In the development process, Daewoong Pharmaceutical is responsible for Phase 3 clinical trials, approval, and sales; Inventage Lab supports preclinical, Phase 1 clinical trials, and product manufacturing; and Withus Pharmaceutical handles product manufacturing.

Seung-ho Jeon, CEO of Daewoong Pharmaceutical, said, “By developing a long-acting injectable hair loss treatment, we aim to provide convenience and stable effects to hair loss patients who currently take daily medication,” adding, “We will maintain close cooperation with our partners who possess the best technology to achieve successful product development.”