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Remestemcel-L - Mesoblast

Drug Profile

Remestemcel-L - Mesoblast

Alternative Names: hMSC - Mesoblast; human mesenchymal stem cells - Mesoblast; JR-0301; JR-031; JR-031EB; MSC-100; MSC-100-IV; OTI-010; OTI-020; OTI-021; Prochymal; Provacel; Stromagen; TEMCELL HS Inj.

Latest Information Update: 09 Nov 2018

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At a glance

  • Originator Osiris Therapeutics
  • Developer JCR Pharmaceuticals; Mesoblast; Osaka University; Osiris Therapeutics
  • Class Anti-inflammatories; Antihypercalcaemics; Cardiovascular therapies; Ischaemic heart disorder therapies; Skin disorder 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 - Graft-versus-host disease; Epidermolysis bullosa; Type 1 diabetes mellitus
  • New Molecular Entity No

Highest Development Phases

  • Marketed Graft-versus-host disease
  • Phase III Crohn's disease
  • Phase II Epidermolysis bullosa; Myocardial infarction
  • Discontinued Acute radiation syndrome; Chronic obstructive pulmonary disease; Type 1 diabetes mellitus

Most Recent Events

  • 13 Dec 2018 Mesoblast plans to submit a rolling BLA with the US FDA for Graft-versus-host disease (In children, Treatment-experienced) in early 2019
  • 29 Oct 2018 JCR Pharmaceuticals plans to prepare regulatory application for submission in Japan for Epidermolysis Bullosa by the end of 2018
  • 24 Oct 2018 Mesoblast expanded partnership with JCR Pharmaceuticals for Epidermolysis bullosa in Japan
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