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FEB 12 2027
UPCOMING · 136 DAYS TO PDUFA

Belite Bio — tinlarebant $BLTE

for Stargardt disease type 1 (juvenile macular dystrophy)

NDA · Priority Review · Orphan · Breakthrough · Fast Track

Accepted JUN 12 2026.

About

Stargardt disease is the most common inherited retinal disease, caused by a faulty gene that leads to macular degeneration beginning in childhood or adolescence and progressive, irreversible vision loss. Tinlarebant is an oral drug that blocks RBP4, a protein that carries vitamin A to the eye, reducing the toxic buildup that damages the retina. By limiting that supply, tinlarebant may slow the growth of retinal lesions and help preserve vision in young people with this condition.

Pivotal trial

DRAGON Phase 3 completed NCT05244304

The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1

Source: ClinicalTrials.gov

Also in development