HK inno.N secures MFDS approval for phase 2 clinical trial of the new JAK inhibitor
March 17, 2025
HK inno.N secures MFDS approval for phase 2 clinical trial of the new JAK inhibitor for atopic dermatitis treatment
- The first topical formulation of JAK-1 inhibitor in South Korea
- Two-track approach for human and animal studies… As for the JAK-1 inhibitor as a veterinary drug, application for phase 3 trial has been made for oral formulation
- Robust pipeline of HK inno.N following the progress of obesity treatment (phase 3, Korea) and now into conquering atopic dermatitis
HK inno.N announced on Monday (17th of February) that IN-115314, its new JAK inhibitor for autoimmune diseases, obtained an approval from the Ministry of Food and Drug Safety (MFDS) on the investigational new drug (IND) for phase 2 trial.
HK inno.N’s IN-115314 is under development as a new therapy targeting mild to moderate atopic dermatitis (AD). This new compound is a Janus kinase-1 (JAK-1) inhibitor for treatment of autoimmune diseases, and since it is topically applied to the site of inflammation for selective inhibition of JAK-1, it is expected to show a low level of systemic absorption and reduce the risk of adverse drug reactions.
IN-115314 is being developed as the first topical formulation (ointment) of JAK-1 inhibitor in South Korea, and its phase 1 study was completed in December 2024.
The phase 1 study observed that IN-115314 outperformed the comparator drug in efficacy for treatment of AD as well as confirming its favorable safety profile, tolerability and pharmacokinetic profile. The phase 2 trial aims to explore optimal dosing regimen for adult AD patients.
The global prevalence of AD is about 3 to 7 percent among adults, with around 970,000 patients treated in South Korea in 2023 alone.
The existing topical AD treatments, such as corticosteroids, calcineurin inhibitors and phosphodiesterase-4 (PDE4) inhibitors, have been approved for use, or are under development; however, the reported limitations of these existing therapies include safety concerns in long-term use or burning and/or stinging sensation during application.
JAK inhibitors, also in development by HK inno.N, have recorded a remarkable pace of global market growth, from USD 20.19 billion (KRW 29 trillion) in 2024 to USD 23.76 billion (KRW 34 trillion) in 2025—an annual growth rate of 17.7 percent.
An HK inno.N official commented, “JAK inhibitors are high in demand with a competing JAK inhibitor sales increasing 50 percent last year to reach USD 508 million (KRW 730 billion),” and further explained, “There is a growing need for a topical alternative for the existing oral JAK inhibitors, so as to overcome the limitations in the safety and efficacy of these therapies. By combining technologies and knowhows in pharmaceutical and cosmetic industry, our new drug aims to provide more diverse treatment options for AD patients”.
HK inno.N is currently developing the new JAK inhibitor-based autoimmune disease drug for both humans and animals, with atopic dermatitis as an indication. The veterinary drug of the new JAK inhibitor is under development as an oral formulation, and HK inno.N has filed an IND application for a phase 3 study. (The End)
[Reference Information]
▶JAK inhibitors: JAK inhibitors work by inhibiting the activity of the Janus kinase family, a type of enzyme, for treatment of a range of inflammatory diseases. The approved indications include autoimmune diseases, such as rheumatoid arthritis and atopic dermatitis.
▶ Source of information on the number atopic dermatitis patients (inpatient/outpatient) in South Korea: Health Insurance Review and Assessment Service
▶Source of information on the global market statistics for JAK inhibitors: Janus Kinase (JAK) Inhibitors Market Report 2025 - Janus Kinase (JAK) Inhibitors Market Overview And Share Analysis)
▶Exchange rate: 1454.60 KRW/USD (As of March 14, 2025)
▶ Comparator product: OPZELURA®(Ruxolitinib, Incyte) (JAK-1, 2 inhibitors /Pharmaceutical company: Incyte/ available in the US market from 2021)
▶ Source of the comparator product sales information: Incyte Reports 2024 Fourth Quarter and Year-End Financial Results