DKF-465

DKF-465 is a salt-modified, incrementally modified drug (IMD) version of ruxolitinib (originally marketed as Jakavi) being developed by Dongkook Pharmaceutical. It is designed as a small molecule inhibitor of Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) to treat intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. By utilizing a modified salt form, DKF-465 aims to circumvent existing patents on the originator's salt and composition, enabling an earlier market entry. Dongkook Pharmaceutical has completed a Phase 1 clinical trial comparing the pharmacokinetics and safety of DKF-465 to Jakavi in healthy volunteers and has submitted a marketing authorization application (NDA) in South Korea.