HK Innoen Receives Approval for Phase 2 Clinical Trial of Atopic Dermatitis Treatment New Drug

First Topical Formulation of JAK-1 Inhibitor Class Developed in Korea

HK Innoen announced on the 17th that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan for phase 2 of the JAK inhibitor class autoimmune disease new drug 'IN-115314.'

'IN-115314,' being developed as a new drug for patients with atopic dermatitis, is an autoimmune disease drug substance with a Janus kinase-1 (JAK-1) inhibitory mechanism. It acts locally on the inflammation site and selectively inhibits only the JAK-1 enzyme. It is expected to have a lower risk of side effects due to less systemic absorption compared to existing drugs.

'IN-115314' is the first topical formulation (ointment) of the JAK-1 inhibitor class being developed domestically, and phase 1 clinical trials were completed last December. Through phase 1, superior atopic dermatitis treatment effects compared to the control drug were observed, and safety, tolerability, and pharmacokinetic properties were confirmed. In phase 2, the appropriate dosage will be determined for adult patients with atopic dermatitis.

Atopic dermatitis is a chronic inflammatory skin disease with a prevalence of about 3-7% among adults worldwide. In Korea, approximately 970,000 patients received treatment for atopic dermatitis in 2023.

The global market size for the JAK inhibitor class being developed by HK Innoen is rapidly growing, recording an annual growth rate of about 17.7%, from $20.19 billion (approximately 29 trillion KRW) in 2024 to $23.76 billion (approximately 34 trillion KRW) in 2025.

An HK Innoen official stated, "Since competing drugs currently sold overseas recorded sales of about 730 billion KRW last year, a 50% increase compared to the previous year, the demand for JAK inhibitors is high. There is a growing need to develop topical formulations as an alternative to overcome the safety and efficacy limitations of existing oral treatments. Through new drug development that combines cosmetic and pharmaceutical technologies, we will provide more diverse treatment options for patients with atopic dermatitis."

Meanwhile, HK Innoen is researching JAK inhibitor class autoimmune disease new drugs for both humans and animals. The animal drug is being developed as an oral formulation, and the clinical trial plan application for phase 3 has been completed.