• Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt disease
• Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease
• Topline data expected in Q4 2025

Belite Bio Inc , a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1).

“We are very pleased to announce the successful completion of the DRAGON trial. This is an important milestone in our mission to bring a treatment to patients living with Stargardt disease,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “With no approved therapies available today, Tinlarebant has the potential to be the first treatment for this devastating inherited macular degeneration. We are deeply grateful to the patients, families, investigators, and study teams worldwide who made this clinical trial possible.”

The DRAGON trial enrolled 104 adolescent subjects across 11 jurisdictions, including the United States, United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). A total of 94 subjects completed the study, with the last study visit conducted on September 11, 2025. The primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability of Tinlarebant will also be assessed.

Belite Bio expects to report top-line results from the DRAGON trial in Q4 2025 and plans to file New Drug Applications in 1H 2026.