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Tinlarebant - Belite Bio

Drug Profile

Tinlarebant - Belite Bio

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

Latest Information Update: 29 Apr 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

  • 22 Apr 2026 Belite expects to complete the new drug application submission in the second quarter of 2026
  • 21 Apr 2026 Preregistration for Stargardt disease (In adults, In adolescents) in USA (PO) - initiated rolling NDA submission
  • 20 Apr 2026 Belite Bio plans a phase III trial for Stargardt disease (In neonates, In infants, In children, In adolescents, In adults, In the elderly, Treatment-experienced) in Belgium, France, Netherlands (PO) in April 2026 (CTIS2025-522460-33-00)

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