Belite Bio, Inc (BLTE) a clinical-stage company announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in its Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1).
In addition, Belite Bio plans to file a New Drug Application or NDA with the FDA in the first half of 2026.
Stargardt disease is a rare genetic eye disease that happens when fatty material builds up on the macula, the small part of the retina needed for sharp, central vision.
Belite Bio's lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD).
DRAGON II clinical trial is a 24-month, randomised, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomised 1:1 to receive either tinlarebant or placebo.
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth.
"Importantly, we remain on track to submit an NDA to the FDA for tinlarebant in the first half of 2026." said Dr. Tom Lin, Chairman and CEO of Belite Bio. He also added that the company has implemented a registration-enabling study that aligns with the requirements of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), supporting Belite Bio to pursue approval in Japan while advancing research for adolescents living with Stargardt disease globally.
Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.
Notably for Tinlarebant, Belite Bio has completed a Phase 3 trial dubbed as DRAGON in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with geographic atrophy.
Over the year, BLTE has traded in a range of $49.00 to $174.78. The stock is up 2.03% at $165.77.
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