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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: 11 Mar 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

  • Phase III Dry macular degeneration; Stargardt disease

Most Recent Events

  • 02 Mar 2026 Belite Bio announces intention to submit NDA to the PMDA for Stargardt disease
  • 02 Mar 2026 Belite Bio announces intention to submit NDA to the US FDA for Stargardt disease in the second quarter of 2026
  • 27 Jan 2026 Belite Bio completes enrolment in its phase II/III DRAGON II trial for Stargardt disease (In adolescents, In adults) in Japan, the US, and the United Kingdom (PO) (NCT0638808)

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