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:

graft-versus-host disease
T86.0D006086

Evidence: FDA-approved indication

Global Availability (1 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus
Standard Marketing AuthorizationApproved

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
Remestemcel-L
Generic Nameremestemcel-L
Brands1 brand available
Active Ingredientremestemcel-L
Drug ClassSteroid-refractory acute graft-versus-host disease
ManufacturerMesoblast
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Reg. StatusFDA Approved (2024)
Countries1 countries
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes