HK inno.N, Secures Phase 3 Success for Korea’s Only Novel JAK-1i for Canine Atopic Dermatitis
HK inno.N, Secures Phase 3 Success for Korea’s Only Novel JAK-1i for Canine Atopic Dermatitis
IN-115314, outperforms existing market competitors in itch relief and skin lesion scores by week 4 of treatment
Two-track approach for human and animal use…with human topical therapeutics currently in domestic Phase 2 trials and clearance for Phase 1b clinical studies in the US
HK inno.N announced on 1 June that it successfully completed a phase 3 trial of IN-115314, an orally-administered, novel treatment for atopic dermatitis in animals (dogs), and submitted an application for marketing authorization.
IN-115314 is the only Janus kinase-1 (JAK-1) inhibitor-based treatment currently under development in Korea. The small-molecule drug was discovered and developed in-house by HK inno.N. Featuring a differentiated mechanism of action that selectively targets JAK-1, the key enzyme in inflammatory signaling pathways, IN-115314 is gaining strong momentum in the pet therapeutics market by outperforming competitors in both efficacy and safety.
The phase 3 study was conducted at 13 veterinary hospitals across Korea and enrolled client-owned dogs diagnosed with atopic dermatitis. The study evaluated improvements in pruritus using the Pruritus Visual Analog Scale (PVAS), skin lesion severity using the Canine Atopic Dermatitis Extent and Severity Index (CADESI), and overall safety following oral administration of either IN-115314 or a marketed JAK-1 inhibitor comparator.
The intervention was administered in three treatment groups: a comparator group receiving the control drug (the reference JAK inhibitor) twice daily for 28 days and two IN-115314 groups receiving either once-daily or twice-daily dosing over the same period.
The study results demonstrated that once-daily dosing of IN-115314 achieved superior efficacy over the comparator. Mean pruritus scores declined from 7.46 at baseline to 2.12 after four weeks of treatment, representing a reduction of more than 50 percent. The difference in the score reduction compared with the comparator ranged from -2.257 to -0.302 points, confirming statistically significant superiority of IN-115314 over existing JAK inhibitor therapies. Furthermore, in terms of the efficacy in skin lesion improvement, the mean CADESI scores decreased from 33.80 at baseline to 16.18 after four weeks, reflecting a 50 percent reduction in disease severity.
Notably, dogs receiving once-daily exhibited a rapid initial response, followed by sustained effect of itch relief over time. Given the chronic and recurrent nature of canine atopic dermatitis that requires ongoing management, the simplified dosing regimen of IN-115314 is expected to improve treatment adherence and satisfaction among the dog owners.
Comprehensive safety assessments confirmed a substantially low risk of side effects. Physiological parameters, including body weight, heart rate, respiratory rate, and body temperature, remained stable throughout the study, and no serious treatment-emergent adverse events were observed.
With the global canine atopic dermatitis therapy market projected to grow from approximately $2.7 billion (approx. KRW 4.058 trillion) in 2025 to $8.2 billion (approx. KRW 12 trillion) by 2034, HK inno.N plans to strengthen its position in the sector with IN-115314. For commercialization of IN-115314, the company is working on expediting the product marketing authorization process through the Animal and Plant Quarantine Agency. At the same time, development of human therapeutics based on the same active ingredient is actively under way. A product (Apoquel (API: oclacitinib)) of a global animal health company (Zoetis) is currently the only commercialized JAK inhibitor therapy for pets, having generated approximately KRW 1.7 trillion in global sales in 2025.
"This study establishes IN-115314 as a meaningful therapeutic alternative, effectively addressing the therapeutic limitations of existing veterinary JAK inhibitors," an official of HK inno.N remarked on the significance of the study findings. “Looking ahead, we will continue to seek expansion by exploring diverse new indications leveraging the JAK inhibitor mechanism, including autoimmune skin diseases and beyond."
In parallel with its veterinary track, HK inno.N is also developing a topical formulation (ointment) of IN-115314 for the treatment of atopic dermatitis in humans. The human therapy is currently undergoing a phase 2 clinical trial in Korea and recently received approval from the US FDA to initiate a phase 1b clinical trial in the United States. By broadening its clinical scope, HK inno.N is poised to establish a vital foothold for future expansion in the global market. (END)
Reference Information
▶ JAK Inhibitors:
A class of therapies that inhibit Janus kinase (JAK), an enzyme in the body, to treat various inflammatory diseases. They are primarily used for autoimmune conditions such as rheumatoid arthritis and atopic dermatitis.
▶ Global Market for Canine Atopic Dermatitis Treatments:
Estimated at USD 2.7 billion (approximately KRW 4.058 trillion) in 2025, projected to grow at USD 8.2 billion (approximately KRW 12 trillion) by 2034.
Source: Global Information, “Global Atopic Dermatitis in Dogs Market: By Drug Type, Route of Administration, Formulation, Distribution Channel, and Region,” 2026
▶ Market Competitor – Apoquel:
Active Ingredient: Oclacitinib
Manufacturer: Zoetis
FDA Approval Year: 2013
▶ Zoetis’s Revenue in 2024:
USD 9.467 billion (approximately KRW 14.22 trillion).
Apoquel accounted for 12% of total revenue, generating USD 1.136 billion (approximately KRW 1.7 trillion) in sales.
Source: Zoetis 2025 Annual Report
▶ Exchange Rate:
KRW 1,502.80 per USD 1 (May 28, 2026)