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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

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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: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 07 Dec 2025

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At a glance

  • Drugs Tinlarebant (Primary)
  • Indications Stargardt disease
  • Focus Adverse reactions; Registrational
  • Acronyms DRAGON 2; DRAGON II
  • Sponsors Belite Bio

Most Recent Events

  • 10 Nov 2025 According to a Belite Bio media release, the company enrolled 34 subjects in the Phase 2/3 trial with a target enrollment of approximately 60 subjects, aged 12 to 20 years old, including approximately 10 Japanese subjects. Data from the Japanese subjects are intended to facilitate a future new drug application in Japan.
  • 27 Aug 2025 Planned End Date changed from 1 Jun 2027 to 1 Jan 2028.
  • 27 Aug 2025 Planned primary completion date changed from 1 Jun 2027 to 1 Dec 2027.

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