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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: 10 Sep 2026

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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

  • Preregistration Stargardt disease
  • Phase III Dry macular degeneration

Most Recent Events

  • 08 Sep 2026 Preregistration for Stargardt disease (In adolescents, In adults) in Japan (PO)
  • 18 Aug 2026 Planned Prescription Drug User Fee Act (PDUFA) date for Stargardt disease (In adolescents, In adults) in USA (PO) is 2027-02-12
  • 12 Aug 2026 Tinlarebant receives priority review status for Stargardt disease in USA

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