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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: 23 Dec 2025

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At a glance

Most Recent Events

  • 15 Dec 2025 According to Organogenesis media release, company announced the successful completion of a planned Type-B meeting with the Food and Drug Administration (FDA) resulting in confirmation to initiate a rolling Biologics Licenses Application (BLA) for ReNu planned before the end of December.
  • 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.

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