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; RYONCIL; Stromagen; TEMCELL HS Inj.Latest Information Update: 03 Apr 2024
Price :
$50
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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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 26 Mar 2024 Mesoblast intends to resubmit BLA for steroid-refractory acute Graft versus host disease (In children) in the second quarter of 2024
- 31 Jan 2024 Mesoblast anticipates a meeting with the US FDA for remestemcel-L in the first quarter of 2024
- 31 Oct 2023 Mesoblast plans a phase III trial for Graft-versus-host-disease (In adults; In the elderly)