Remestemcel-L - Mesoblast

Drug Profile

Remestemcel-L - Mesoblast

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

Latest Information Update: 29 Dec 2016

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At a glance

  • Originator Osiris Therapeutics
  • Developer JCR Pharmaceuticals; Mesoblast; Osiris Therapeutics
  • Class Antineoplastics; Stem cell therapies
  • Mechanism of Action Cell replacements; Tissue 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; Type 1 diabetes mellitus
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

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

Most Recent Events

  • 23 Dec 2016 Mesoblast and Mallinckrodt Pharmaceuticals enter into an agreeement for the development and commercialisation of remestemcel-L, worldwide excluding Japan and China for Graft-versus-host disease
  • 14 Nov 2016 Interim efficacy data from a phase III trial in Graft versus Host Disease released by Mesoblast
  • 17 Mar 2016 Launched for Graft-versus-host disease (In children, Treatment-experienced, In adults) in Japan (IV)
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