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Remestemcel-L - Mesoblast

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Drug Profile

Remestemcel-L - Mesoblast

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

Latest Information Update: 04 Sep 2025

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At a glance

  • Originator Osiris Therapeutics
  • Developer Cleveland Clinic; JCR Pharmaceuticals; Mesoblast; Osaka University; Osiris Therapeutics
  • Class Mesenchymal 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; Type 1 diabetes mellitus; Epidermolysis bullosa
  • New Molecular Entity No

Highest Development Phases

  • Marketed Graft-versus-host disease
  • Preregistration Epidermolysis bullosa
  • Phase III Back pain; Crohn's disease; Myocardial infarction; SARS-CoV-2 acute respiratory disease
  • Phase I/II Brain hypoxia-ischaemia; Ulcerative colitis
  • Discontinued Acute radiation syndrome; Chronic obstructive pulmonary disease; Type 1 diabetes mellitus

Most Recent Events

  • 29 Aug 2025 Mesoblast plans registration trial for label expansion for inflammatory colitis (In adults, In children)
  • 18 Jul 2025 Mesoblast held a Type B meeting with US FDA for Remestemcel-L to discuss a pivotal trial in Graft-versus-host disease (In adults)
  • 18 Jul 2025 Mesoblast plans a registration trial for label expansion in Graft-versus-host disease (In adults) in USA (IV),

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