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A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

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Trial Profile

A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs Bimatoprost-grenod (Primary) ; Latanoprost
  • Indications Ocular hypertension; Open-angle glaucoma
  • Focus Registrational; Therapeutic Use
  • Acronyms Denali
  • Sponsors NicOx; Ocumension Therapeutics

Most Recent Events

  • 02 Oct 2025 According to a Nicox media release, this Denali trial also included a long-term safety extension from 6 months through to 12 months and was jointly conducted and equally financed with our Chinese partner, Ocumension Therapeutics.
  • 02 Oct 2025 According to a Nicox media release, NCX 470 NDA submission in the United States: expected in H1 2026 and in China: expected shortly after submission in the U.S.
  • 02 Oct 2025 Results from this trial presented in a NicOx media release.

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