Drug Profile

Azimplacel - NuCel

Alternative Names: Amnuvx; Human amniotic allograft; NuCel; ReNu™

Latest Information Update: 10 Jul 2026

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At a glance

Originator NuCel; NuTech Medical
Developer NuCel; Organogenesis
Class Stem cell therapies
Mechanism of Action Cell replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Preregistration Osteoarthritis
Market Withdrawal Bone disorders
Discontinued Intervertebral disc degeneration

Most Recent Events

07 Jul 2026 US FDA assigns PDUFA action date of (24/04/2027) for Amniotic cell therapy for Osteoarthritis
06 Jul 2026 US FDA accepts BLA for Amniotic cell therapy for Osteoarthritis for review (Intra-articular)
29 Apr 2026 Preregistration for Osteoarthritis in USA (Intra-articular)

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