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Human acellular vessel - Humacyte

Drug Profile

Human acellular vessel - Humacyte

Alternative Names: Acellular Tissue Engineered Vessel - Humacyte; ATEV; HAV; HAVG graft implantation; HUMACYL™; HUMAGRAFT™; Human acellular vascular graft - Humacyte; HUMAPASS™

Latest Information Update: 08 Jul 2024

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At a glance

  • Originator Humacyte
  • Class Tissue transplantation therapies
  • Mechanism of Action Tissue replacements
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Vascular injuries
  • Phase III Renal failure
  • Phase II Peripheral arterial disorders
  • Preclinical Cardiovascular disorders; Congenital heart defects; Type 1 diabetes mellitus

Most Recent Events

  • 01 Jul 2024 Human acellular vessel - Humacyte receives Regenerative Medicine Advanced Therapy (RMAT) status for Peripheral arterial disorders in USA
  • 13 Feb 2024 FDA assigns PDUFA action date of 10/08/2024 for Human acellular vessel for Vascular Trauma (Implant)
  • 12 Feb 2024 Preregistration for Vascular injuries in USA (Implant)
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