Diabetic patients face challenges in wound healing, requiring significant time and financial investment in medical care, not only impacting their quality of life but, in severe cases, leading to disability or death. FESPIXON^®, with the most rigorous scientific approach, explores the potential of botanical medicine for chronic wound healing. From pre-clinical efficacy studies, optimal formulation ratios, and mechanism of action experiments to large-scale international clinical trials, each step confirms the significant effectiveness of FESPIXON^® in healing chronic wounds.

In 2012, the international multicenter Phase III clinical trial commenced. A total of 236 patients were recruited from 21 major medical or clinical centers in Taiwan, the United States, and China. The study results showed an incidence of wound complete healing exceeding 60% in ON101 (FESPIXON^®’s research code). Subgroup analysis for different hard to heal wounds also demonstrated the significant efficacy of ON101.

The clinical effectiveness of FESPIXON^® is attributed to its unique mechanism of action, regulating macrophages in the wound environment by reducing pro-inflammation M1 macrophages and increasing pro-healing M2 macrophages, thereby promoting rapid and complete wound healing.

In June 2021, FESPIXON^® was officially launched in Taiwan, and by end of 2023, it has gone through new drug approval reviews in Macau, Singapore, Malaysia, and China, and obtained marketing approvals. The introduction of FESPIXON^® not only spares patients from the agony of amputation but also accelerates the healing process, alleviating the caregiving burden on friends and family of diabetic foot patients. Whether in clinical efficacy or accumulated post-market evidence, FESPIXON^® demonstrates a paradigm shift, bringing new hope for healing to a vast number of diabetic foot ulcer patients!