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The second Phase 3 randomized controlled trial of ReNu for knee osteoarthritis (OA).

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Trial Profile

The second Phase 3 randomized controlled trial of ReNu for knee osteoarthritis (OA).

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2025

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At a glance

Most Recent Events

  • 07 Nov 2025 New trial record
  • 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.
  • 25 Sep 2025 Primary endpoint (the difference between ReNu and Saline groups in the reduction in knee pain at six months assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale.) has not met

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