Remestemcel-L
Orphan Drug Cold Chain RequiredFDA Approved (2024)
Description
An allogeneic bone-marrow-derived mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children aged 2 months and older. First MSC therapy approved by the FDA (December 2024).
Indications & Therapeutic Use
Steroid-refractory acute graft-versus-host disease
Linked Diseases:
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| Standard Marketing Authorization | — | — | Approved |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Remestemcel-L
| Generic Name | remestemcel-L |
| Brands | 1 brand available |
| Active Ingredient | remestemcel-L |
| Drug Class | Steroid-refractory acute graft-versus-host disease |
| Manufacturer | Mesoblast |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Required |
| Reg. Status | FDA Approved (2024) |
| Countries | 1 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes