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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: 21 Feb 2025

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At a glance

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

    • Most Recent Events

    • 10 Sep 2024 According to a Belite Bio media release, approximately 60 subjects, aged 12 to 20 years old, including approximately 10 Japanese subjects, are targeted for enrollment in the Phase 2/3 portion of the trial with a 1:1 randomization (Tinlarebant:placebo). The data from the Japanese subjects is intended to facilitate future NDA applications in Japan.
    • 10 Sep 2024 According to a Belite Bio media release, company announced that the first patient has been dosed at the Tokyo Medical Center in the Phase 2/3 portion of its DRAGON II clinical trial evaluating Tinlarebant for the treatment of STGD1.
    • 09 Aug 2024 According to a Belite Bio media release, enrollment with 6 subjects in japan for its phase 1b portion of this trial has been completed.

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