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Tinlarebant - Belite Bio

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Drug Profile

Tinlarebant - Belite Bio

Alternative Names: aka LBS-008; BPN-14967; LBS-008

Latest Information Update: 04 Dec 2025

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At a glance

  • Originator Columbia University
  • Developer Belite Bio
  • Class Eye disorder therapies; Fluorinated hydrocarbons; Ketones; Piperidines; Pyrazoles; Pyridines; Small molecules
  • Mechanism of Action RBP4 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Stargardt disease
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Dry macular degeneration; Stargardt disease

Most Recent Events

  • 01 Dec 2025 Adverse events data from a phase III DRAGON trial in Stargardt disease released by Belite Bio
  • 02 Nov 2025 UK's MHRA agrees to accept Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease
  • 15 Oct 2025 Center for Drug Evaluation of NMPA agrees to accept the NDA with priority review for tinlarebant for Stargardt disease

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