Belite Bio Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease

Core Insights - Belite Bio Inc has completed the last subject visit in the Phase 3 DRAGON clinical trial for Tinlarebant, aimed at treating Stargardt disease type 1 (STGD1) [1][2] - The DRAGON trial involved 104 adolescent subjects across 11 jurisdictions, with a 2:1 randomization of Tinlarebant to placebo, and 94 subjects completed the study [2] - Top-line results from the DRAGON trial are expected to be reported in Q4 2025, with plans to file New Drug Applications in the first half of 2026 [3] Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including STGD1 and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD) [5] - The lead candidate, Tinlarebant, is an oral therapy designed to reduce the accumulation of vitamin A-based toxins (bisretinoids) that contribute to retinal disease [4][5] - Tinlarebant has received multiple designations, including Fast Track and Rare Pediatric Disease in the U.S., and Orphan Drug Designation in the U.S., Europe, and Japan [4][7]