Evicenter
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Tinlarebant (LBS-008)

Stargardt disease type 1

Manufacturer
Belite Bio
Regulatory submission
NDA submitted June 2026
Last updated
66 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Place in treatment, anticipated use, and care setting

1 evidence topic · 6 sources

Summary

Tinlarebant is being developed as an oral treatment for Stargardt disease type 1. DRAGON studied participants aged 12–20 years with established atrophic lesions and visual acuity of 20/200 or better. This trial population should not be equated with a finalized approved population. The sponsor anticipates confirmatory ABCA4 testing, specialty-pharmacy fulfillment, and patient-support programs. These are proposed access arrangements rather than an approved care pathway.