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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

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

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

Most Recent Events

  • 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, targeted enrollment of 60 subjects was reached in January 2026. Subjects who passed screening before enrollment cut off are allowed to be enrolled in the trial through early March. 72 subjects were enrolled as of February 27, 2026.

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