Drug intelligence / Profile preview

azimplacel

Development stage
Unknown
Lead developer
Organogenesis
Administration
Intraarticular
01

Overview

**Azimplacel**, previously developed as **ReNu**, is a cryopreserved human amniotic suspension allograft developed by Organogenesis for intra-articular treatment of pain associated with symptomatic knee osteoarthritis. The tissue-derived biologic contains amniotic fluid cells, micronized amniotic membrane, extracellular-matrix components, and endogenous growth-factor and cytokine content. It is intended to provide local symptom relief and support joint tissue homeostasis through multifactorial anti-inflammatory, extracellular-matrix, and regenerative signaling rather than through one defined molecular target. ReNu received FDA Regenerative Medicine Advanced Therapy designation for knee osteoarthritis in 2021. In July 2026, the FDA accepted Organogenesis' biologics license application for review; the proposed proprietary name is Amnuvx and the PDUFA target action date is April 24, 2027.

Brand names
ReNuAmnuvx
Other names
Amniotic suspension allograftOrganogenesis ASA
02

Targets

IL1RN (Interleukin-1 receptor antagonist)TGFB (GARP–latent transforming growth factor beta 1 complex)

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