Overview of October 2025 MFDS IND Approvals
MFDS IND approval status data show that South Korea recorded 58 Investigational New Drug approvals in October 2025, reinforcing its role as a global research hub. During the third and fourth weeks, approvals spanned oncology, infectious diseases and respiratory disorders, and there was a balance between late‑phase global studies and early‑phase domestic trials. Two of the three approvals in the fourth week were Phase I studies led by local companies, underscoring the growth of the Korean early‑stage ecosystem.
Therapeutic Trends: Oncology Leads IND Approvals
Key Oncology and Immunology Trials Approved
Oncology dominated the therapeutic landscape. Approvals in the third week included ST Cube’s Phase I trial of nelmastobart plus docetaxel, Icon Korea’s RO7790121 Crohn’s disease study, and PRA Korea’s trial of zanzalintinib, illustrating partnerships between global sponsors and domestic expertise. In immune and dermatology indications, approvals for ritlecitinib and PF‑07248144, lesigercept and guselkumab reflected a diversification into autoimmune and skin‑disease research.
The expansion of domestic early‑stage research deserves attention. Trials such as DongKook’s DKF‑460 vs DKF‑460R, Vastera Therapeutics’ VTB‑10, and Daewoong’s DW4421 strengthened the local pipeline. Investigator‑initiated and hospital‑based trials are also rising; hospitals like Korea University Medical Center and Seoul National University Hospital are leading studies on topics ranging from fruquintinib to pediatric pain management.
In the fourth week, Microbiotics received approval for a Phase I study of MP101 against Pseudomonas aeruginosa pneumonia, and Myeongmun obtained approval for a comparative study of MMP‑123 vs MMP‑123R. PRA Korea obtained clearance for the global Phase III ALPACCA study comparing permonertinib with osimertinib or apatinib in patients with EGFR‑mutated lung cancer, incorporating Korean sites and offering local patients early access to innovative therapies. This balanced portfolio demonstrates that South Korea is a strategic partner for both early‑ and late‑phase studies.
South Korea’s MFDS IND review system, introduced in 2002, has continually improved. In 2022 there were 711 approvals; 49 percent were globally sponsored, 35.3 percent were locally sponsored and 16 percent were investigator‑initiated. The review process involves five steps—including preliminary consultation, safety, quality and clinical reviews—and is completed within 30 working days. This efficient regulation helped South Korea rank fourth worldwide in the number of clinical trials in 2023 and seventh in Phase I multinational trials.
In summary, the October 2025 MFDS IND approval landscape reveals the rise of domestic early‑phase research, a diversified portfolio extending into immunology and dermatology, and the international appeal of Korean research infrastructure. Based on these approvals, our team offers tailored proposals and shares regulatory updates and trial opportunities via our newsletter. Click the Contact Us button to discuss your IND submission strategy and clinical trial design with our experts.
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