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Phase 3 prospective, double-blind, multicenter, placebo-controlled, parallel group, randomized control trial (RCT) of ReNu in patients with moderate to severe symptomatic knee osteoarthritis

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Trial Profile

Phase 3 prospective, double-blind, multicenter, placebo-controlled, parallel group, randomized control trial (RCT) of ReNu in patients with moderate to severe symptomatic knee osteoarthritis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2025

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At a glance

Most Recent Events

  • 25 Sep 2025 According to Organogenesis media release, the company will will request a pre-BLA meeting with the FDA by the end of October to discuss the submission pathway, including using the combined efficacy analysis from both Phase 3 studies to support a BLA approval.
  • 11 Nov 2024 Interim results presented in the Organogenesis Holdings Media Release.
  • 02 May 2024 Results published in the Media Release

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