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Leukocyte cell therapy - Enlivex Therapeutics

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Drug Profile

Leukocyte cell therapy - Enlivex Therapeutics

Alternative Names: Allocetra; Allocetra-OTS; OTS-Allocetra

Latest Information Update: 16 Jul 2026

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At a glance

  • Originator Hadassah Medical Organization
  • Developer Enlivex Therapeutics; Hadassah Medical Organization
  • Class Antineoplastics; Cell therapies; Immunotherapies
  • Mechanism of Action Leukocyte replacements; Macrophage modulators
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease
  • New Molecular Entity No
  • Available For Licensing Yes - Sepsis

Highest Development Phases

  • Phase II Graft-versus-host disease; Inflammation; Lung disorders; Multiple organ failure; Osteoarthritis; SARS-CoV-2 acute respiratory disease
  • Phase I Psoriatic arthritis
  • No development reported Crohn's disease; Gout; Multiple sclerosis; Rheumatoid arthritis; Transplant rejection
  • Discontinued COVID 2019 infections; Mesothelioma; Peritoneal cancer; Solid tumours

Most Recent Events

  • 13 Jul 2026 Enlivex Therapeutics plans to schedule a Type B meeting with the US FDA to conduct a comprehensive, multidisciplinary discussion of the Allocetra™ development program
  • 13 Jul 2026 Leukocyte cell therapy - Enlivex Therapeutics receives Regenerative Medicine Advanced Therapy (RMAT) status for Osteoarthritis in USA
  • 13 Jul 2026 Enlivex Therapeutics completes a phase-I/II trial in Osteoarthritis (Treatment-experienced) in Denmark, Israel, Moldova (Intra-articular) (NCT06233474)

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