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Rexlemestrocel L - Mesoblast

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Drug Profile

Rexlemestrocel L - Mesoblast

Alternative Names: Allogeneic mesenchymal precursor cells - Mesoblast; Allogeneic STRO-3 immunoselected bone marrow-derived mesenchymal precursor cells (MPCs) - Mesoblast; CEP-41750; Mesenchymal stem cell therapy - Mesoblast; MPC 06; MPC-06-ID; MPC-150; MPC-150-IM; MPC-25; MPC-25-IC; MPC-25-Osteo; MPC-300; MPC-300-IV; MPC-CBE; MPC-MICRO-IO; MSB-CAR001; MSC-75-IA; NeoFuse; Replicart; Revascor

Latest Information Update: 30 Jun 2025

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At a glance

  • Originator Hanson Institute; Institute of Medical and Veterinary Science
  • Developer Mesoblast
  • Class Antineoplastics; Mesenchymal stem cell therapies; 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.

    Yes - Heart failure; Haematological malignancies; Hypoplastic left heart syndrome
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Back pain; Heart failure
  • Phase II Intervertebral disc degeneration; Myocardial infarction; Rheumatoid arthritis; Type 2 diabetes mellitus
  • Phase I/II Diabetic nephropathies; Hypoplastic left heart syndrome
  • Discontinued Acute myeloid leukaemia; Age-related macular degeneration; Fracture; Hodgkin's disease; Lung disorders; Non-Hodgkin's lymphoma; Osteoarthritis; Peripheral arterial disorders; Precursor cell lymphoblastic leukaemia-lymphoma; Skin ulcer

Most Recent Events

  • 12 Jun 2025 Mesoblast plans a Type B meeting with FDA to discuss the accelerated approval pathway for rexlemestrocel-L in the treatment of Heart failure the second quarter of 2025.
  • 11 Jun 2025 Mesoblast held a Type B meeting with US FDA for filing for a Biologics License Application (BLA) in Heart failure
  • 11 Jun 2025 Mesoblast plans for filing for a Biologics License Application (BLA) in Heart failure

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