luspatercept

Orphan Drug Cold Chain RequiredFDA Approved, EMA Approved

Description

Luspatercept is a recombinant fusion protein that acts as an erythroid maturation agent by binding to select TGF-beta superfamily ligands. It promotes late-stage erythropoiesis and reduces transfusion burden in patients with beta-thalassemia including hemoglobin E-beta-thalassemia syndrome. The drug enhances red blood cell maturation and production.

Indications & Therapeutic Use

beta-thalassemia, hemoglobin E-beta-thalassemia syndrome, myelodysplastic syndromes with ring sideroblasts

Global Availability (8 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

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

Fulfilment Partner
luspatercept
Generic Nameluspatercept
Brands1 brand available
Active Ingredientluspatercept-aamt
Drug Classbeta-thalassemia
ManufacturerBristol Myers Squibb/Celgene
Dosage Formssubcutaneous injection, 25 mg/vial, 75 mg/vial powder for solution
Medical CodeB03XA05
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Lead Time10 days
Reg. StatusFDA Approved, EMA Approved
Clinical TrialNCT02604433
Countries8 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations9 Validated Nodes