Belite Bio Inc. has announced the completion of the last subject visit in its Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1). This trial marks a significant milestone in the quest for effective therapies for a condition that currently lacks approved treatment options.
Dr. Tom Lin, Chairman and CEO of Belite Bio, emphasized the importance of this achievement for patients suffering from Stargardt disease, expressing gratitude to all participants involved in the trial. The DRAGON trial enrolled 104 adolescent subjects across 11 jurisdictions, including the U.S., U.K., and several European and Asian countries, with a 2:1 randomization of Tinlarebant to placebo. A total of 94 subjects completed the study, which focused on the growth rate of atrophic lesions as its primary efficacy endpoint.
Belite Bio anticipates reporting top-line results from the trial in Q4 2025, with plans to file New Drug Applications in the first half of 2026. Tinlarebant represents a novel approach to treating STGD1 by targeting the accumulation of harmful bisretinoids in the retina, and it has received multiple designations aimed at expediting its development. As Belite continues to advance its pipeline, the outcomes of the DRAGON trial could significantly impact the treatment landscape for degenerative retinal diseases.
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