Trial Profile

A Phase 1b Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects With Stargardt Disease and a Phase 2/3 Randomized, Double-masked, and Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects With Stargardt Disease

Status: Active, no longer recruiting

Phase of Trial: Phase II/III

Latest Information Update: 16 Mar 2026

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At a glance

12 Mar 2026 Planned End Date changed from 1 Jan 2028 to 1 Feb 2028.
12 Mar 2026 Planned primary completion date changed from 1 Dec 2027 to 1 Feb 2028.
02 Mar 2026 According to a Belite Bio media release, the company is on track to submit an NDA to the FDA in the second quarter of 2026.

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