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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: 26 Jul 2026

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At a glance

  • Drugs Azimplacel (Primary)
  • Indications Osteoarthritis
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 06 Jul 2026 According to Organogenesis media release, company announced that the U.S. Food and Drug Administration (FDA) has completed their filing determination and accepted for review the Company's Biologics License Application (BLA) for ReNu. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.
  • 29 Apr 2026 According to Organogenesis media release, company announced the completion of a rolling Biologics License Application BLA submission to the FDA for ReNu,knee osteoarthritis (OA). initiated the rolling BLA submission in December 2025 with non-clinical modules and has now completed the application with the submission of the clinical and chemistry, manufacturing, and controls modules and look forward to continuing our productive discussions with the FDA during the review process.
  • 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.

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