ResolvedClinical TrialsReleased Dec 1, 2025

DRAGON Phase 3: tinlarebant (5 mg daily) in adolescent Stargardt disease type 1 (STGD1)

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Trial setup

- Study: DRAGON, pivotal global Phase 3. - Population: adolescents with Stargardt disease type 1 (STGD1). - Randomization: 2:1 tinlarebant vs placebo; double-masked; placebo-controlled; multi-center. - Duration: 24 months. - Primary endpoint: % reduction (tinlarebant vs placebo) in growth rate of retinal lesions measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging (study eye), with fellow-eye analysis also reported. - Key secondary endpoint: % reduction in decreased autofluorescence (DAF = DDAF + QDAF) lesion growth (study eye and fellow eye).

Model leaderboard

How AI models scored forecasting this event. Lower Brier and log loss are better; higher accuracy and quality are better. Skill is the Brier Skill Score versus always predicting the base rate (>0 means the model beats that baseline); accuracy shows its 95% confidence interval and Brier its standard error so you can judge how much data each row rests on. Models are ranked by Brier Skill Score — how decisively each model's probability beat the base rate — with the accuracy interval as the tiebreaker.

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Resolution

Belite Bio reported that the global Phase 3 DRAGON trial met its primary endpoint: tinlarebant reduced study-eye DDAF lesion growth rate by 35.7% versus placebo, with a 33.6% reduction reported in the fellow eye. The company also reported benefit on the key secondary endpoint DAF lesion growth (DAF = DDAF + QDAF): 33.7% reduction in the study eye and 32.7% reduction in the fellow eye. Pharmacodynamically, the 5 mg daily dose reduced RBP4 by a mean of ~80% relative to baseline, and the press release reported four treatment-related discontinuations.

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