Merry Life Biomedical announced on the 23rd that its investigational new drug for Alzheimer’s disease (AD), TML-6, has received FDA approval to initiate a global Phase II clinical trial. Following the launch of its Phase I trial in the U.S. in June last year, the FDA formally approved Merry Life’s Phase II clinical trial protocol in May this year. The trial is scheduled to begin in the first quarter of 2026, enrolling 210 participants for a 12-month study.
Merry Life Biomedical was established in October 2018 by Professor Su, Ih-Jen, Chair Professor at Southern Taiwan University of Science and Technology, and his research team, with support from Taiwan’s National Science and Technology Council under the Value Creation Program. The team successfully identified TML-6, a multi-target molecule addressing key pathogenic mechanisms of AD, as a promising drug candidate.
According to Su, following positive preclinical results, TML-6 received FDA IND clearance in June 2024 and proceeded to Phase I clinical trials in Los Angeles, where it demonstrated favorable safety and pharmacokinetic profiles. Notably, the trial employed blood-based biomarkers as efficacy indicators—an emerging approach in AD drug development. TML-6 is also the world’s first new drug targeting the autolysosome pathway, a novel mechanism in the treatment of AD, marking a significant step for Taiwan’s drug innovation on the international stage.
Su emphasized that there is currently no cure to halt or reverse the progression of dementia. Historically, research has focused on the abnormal accumulation of amyloid-β (Aβ) plaques and tau protein tangles in the brains of AD patients. Despite global investments of tens of billions of U.S. dollars over the past three decades in the development of hundreds of AD drugs, only two anti-amyloid monoclonal antibodies have been approved by the FDA to date, with one launching in Taiwan in June this year. However, these antibody therapies have limited efficacy, significant side effects, and high costs, as they target only extracellular Aβ. The medical community continues to look forward to the introduction of oral small-molecule drugs with multi-target mechanisms.
Merry Life has planned a global Phase II trial across 19 medical centers in the United States, Sweden, and Taiwan. Following FDA consultation in May 2025, the trial protocol has been finalized, and the study involving 210 participants is set to begin in early 2026.
As a gesture of appreciation, Merry Life will present its “Pioneer Award” at the upcoming shareholders’ meeting to Dr. Gary Small, former Director of the UCLA Alzheimer’s Disease Research Center, in recognition of his six years of advisory support in guiding TML-6’s development. Dr. Small will serve as the Chief Advisor for the Phase II clinical trial of TML-6.
Resource: 美力齡阿茲海默症新藥 TML-6 獲 FDA 許可全球二期臨床
