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Randomized Controlled, Multicenter, Double-Masked, Parallel Phase III Trial to Evaluate the Efficacy and Safety of Lotilaner Ophthalmic Solution for the Treatment of Demodex Blepharitis in China With an Open-Label Pharmacokinetics Sub-Study

Trial Profile

Randomized Controlled, Multicenter, Double-Masked, Parallel Phase III Trial to Evaluate the Efficacy and Safety of Lotilaner Ophthalmic Solution for the Treatment of Demodex Blepharitis in China With an Open-Label Pharmacokinetics Sub-Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2025

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At a glance

  • Drugs Lotilaner (Primary)
  • Indications Blepharitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms LIBRA
  • Sponsors LianBio; Tarsus Pharmaceuticals

Most Recent Events

  • 13 Jan 2025 According to a LianBio media release, the Chinese regulatory agency, National Medical Products Administration, accepted the New Drug Application (NDA) submitted by Tarsus's partner, Grand Pharmaceutical Group Ltd., for TP-03 for DB. A decision is anticipated in 2027.
  • 19 May 2024 Status changed from active, no longer recruiting to completed.
  • 14 Mar 2024 Planned End Date changed from 1 Feb 2024 to 1 Apr 2024.

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