Belite Bio Inc (NASDAQ: BLTE) has initiated a rolling submission of a new drug application to the U.S. Food and Drug Administration for tinlarebant, an oral therapy for treating Stargardt disease type 1, according to a company statement.

The clinical-stage drug development company expects to complete the new drug application submission in the second quarter of 2026. The rolling submission operates under the FDA's Breakthrough Therapy Designation, which the agency previously granted to tinlarebant for this rare inherited retinal disorder.

Stargardt disease type 1 is caused by mutations in the ABCA4 gene. The condition typically begins in adolescence and can lead to legal blindness. Currently, no approved treatments exist for the disease.

Tinlarebant works by reducing levels of serum retinol binding protein 4, which transports vitamin A from the liver to the eye. This mechanism aims to decrease the formation of bisretinoids, vitamin A-based compounds that accumulate in the retina and contribute to retinal degeneration in Stargardt disease.

The FDA has granted tinlarebant multiple designations including Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations in the United States. The drug has also received Orphan Drug Designation in the U.S., Europe, and Japan, plus Sakigake Designation in Japan.

Belite Bio has completed a Phase 3 trial called DRAGON in adolescent Stargardt disease patients. The company is currently conducting additional trials, including DRAGON II in adolescent patients and PHOENIX in subjects with geographic atrophy, a form of advanced dry age-related macular degeneration.

The San Diego-based company focuses on developing treatments for degenerative retinal diseases with unmet medical needs.