Daewoong Pharmaceutical Applies for Approval of ‘Flodicitinib,’ Korea’s First New Atopic Dermatitis Drug for Dogs

Daewoong Pharmaceutical announced on the 14th that it filed an application on the 24th of last month with the Animal and Plant Quarantine Agency (APQA) for marketing authorization of the atopic dermatitis treatment for companion dogs ‘Flodicitinib’.
This new drug is a small-molecule medicine discovered in-house by Daewoong Pharmaceutical and developed specifically as a veterinary medicine for companion animals. Through non-clinical and clinical studies that meet international standards, its safety and efficacy have been verified.
Flodicitinib is the first domestically developed atopic dermatitis treatment for dogs in the Janus kinase inhibitor (JAK inhibitor) class. JAK inhibitors are therapies that alleviate pruritus and skin inflammation by blocking inflammatory signal transmission that causes atopic dermatitis.
Flodicitinib selectively modulates Janus kinase 3 (JAK3) and is being evaluated as a therapeutic candidate that enhances efficacy and reduces the burden of side effects by simultaneously inhibiting other pathways that excessively amplify immune responses.
After completing phase 2 clinical trials in 2023, the drug entered phase 3 trials in 2024 and successfully concluded phase 3 at the end of last year. In the phase 3 study, lesion improvement was observed from week 2 of administration, with the Canine Atopic Dermatitis Extent and Severity Index (CADESI) score decreasing from 56 to 44, and continuing to improve to 35 by week 12.
Even in severe dogs (CADESI score of 60 or higher), Flodicitinib showed superior therapeutic effects compared with the control drug. While the control drug improved CADESI by an average of 29.2 points, Flodicitinib achieved an average improvement of 34.4 points.
Therapeutic effects were also confirmed in dogs that did not respond to existing treatments or had developed resistance. Existing JAK inhibitors are known to lose effectiveness or induce resistance in about one-third of all users.
Flodicitinib demonstrated potential applicability even in cases that had not been adequately controlled with existing drugs. In addition, in the Flodicitinib treatment group, levels of Immunoglobulin E (IgE) were reduced by more than 30% compared with the control drug, indicating that the therapy may act on the underlying cause of the disease.
Currently, a phase 1 clinical trial of a human medicine based on the same active ingredient as Flodicitinib is also underway. Following its marketing authorization application for ‘Enblo Pet’ in October last year, Daewoong Pharmaceutical is strengthening its research and development capabilities through the development of Flodicitinib.
Flodicitinib was selected in 2022 as a project under the Ministry of Agriculture, Food and Rural Affairs (MAFRA)’s Pet Industry Technology Development Program. Daewoong Pharmaceutical plans to pursue expansion into various indications using the JAK inhibitor mechanism.
Daewoong Pharmaceutical has now applied for marketing authorization for Flodicitinib and is concurrently conducting a phase 1 clinical trial for human use.

vrdw88@fnnews.com Kang Jung-mo Reporter