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Rexlemestrocel L - Mesoblast/Teva Pharmaceutical Industries

Drug Profile

Rexlemestrocel L - Mesoblast/Teva Pharmaceutical Industries

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-75-IA; MPC-CBE; MPC-MICRO-IO; MSB-CAR001; NeoFuse; Replicart; Revascor; Rexlemestrocel-L - Mesoblast/Teva Pharmaceutical Industries

Latest Information Update: 07 May 2024

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At a glance

  • Originator Hanson Institute; Institute of Medical and Veterinary Science
  • Developer Angioblast Systems; Boston Childrens Hospital; Mesoblast; Teva Pharmaceutical Industries
  • Class Anti-inflammatories; Anti-ischaemics; Antihypercalcaemics; Antineoplastics; Antirheumatics; Heart failure therapies; Mesenchymal stem cell therapies; Skin disorder therapies; Stem cell therapies; Vascular disorder therapies
  • Mechanism of Action Cell replacements; Osteogenesis stimulants; Tissue replacements
  • Orphan Drug Status

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

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

Highest Development Phases

  • Phase III Acute myeloid leukaemia; Back pain; Heart failure; Hodgkin's disease; Intervertebral disc degeneration; Non-Hodgkin's lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Phase II Myocardial infarction; Osteoarthritis; Rheumatoid arthritis; Spondylosis; Type 2 diabetes mellitus
  • Phase I/II Diabetic nephropathies; Hypoplastic left heart syndrome
  • No development reported Age-related macular degeneration; Fracture; Lung disorders; Peripheral arterial disorders; Skin ulcer

Most Recent Events

  • 30 Apr 2024 Mesoblast announces intention to submit BLA to the US FDA for Hypoplastic left heart syndrome
  • 30 Apr 2024 Mesoblast plans a phase III trial for Back pain and Intervertebral disc degeneration in May 2024 in USA and Europe (Intralumbar, Injection) (NCT06325566)
  • 11 Mar 2024 Mesoblast announces intention to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation
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