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Luspatercept · Reblozyl, ACE-536

Fusion protein · Antagonist of TGF-β superfamily ligands · developed by Celgene

Approved FDA, Nov 2019

BMY Developer

1 Registered trials

What is Luspatercept?

Luspatercept-aamt is a recombinant fusion protein that binds TGF-β superfamily ligands, diminishing Smad2/3 signaling to promote erythroid maturation and increase erythropoiesis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Reblozyl, ACE-536
Drug type: Fusion protein
Targets: TGF-β superfamily ligands, Smad2/3 (secondary target)
Mechanism: Antagonist of TGF-β superfamily ligands
Pathways: Smad2/3 signaling, erythroid maturation, erythropoiesis
Therapy area: Hematology
Developer: Celgene Corp (BMY)
FDA status: Approved as Reblozyl (November 8, 2019), BLA761136 · FDA label
UNII: AQK7UBA1LS

✅ FDA-approved uses

Anemia in adult patients with beta thalassemia who require regular red blood cell transfusions
Anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk myelodysplastic syndromes
Anemia failing an erythropoiesis stimulating agent in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring siderobla

From the indications section of the FDA label (version of Feb 27, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06971185	N/A	Myelodysplastic Syndromes (MDS)	Completed	BMY

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Myelodysplastic Syndromes (MDS)

More from Celgene

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BMY page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z