Drug Profile

AVB 114

Alternative Names: Autologous mesenchymal stromal cell coated fistula plug - Avobis Bio; AVB-114; MSC-AFP

Latest Information Update: 14 Aug 2025

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At a glance

Originator Mayo Clinic; W. L. Gore & Associates
Developer Avobis Bio; Mayo Clinic
Class Mesenchymal 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

Phase II Rectal fistula

Most Recent Events

07 Aug 2025 Avobis Bio files a request to the US FDA for Regenerative Medicine Advanced Therapy designation for AVB 114 for Rectal fistula
07 Aug 2025 Avobis Bio plans a phase III trial for Rectal fistula in USA (Parenteral)
27 Feb 2025 AVB 114 receives Fast Track designation for Rectal fistula [Parenteral] (Treatment-experienced) in USA

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