Last update 07 Jul 2025

Luspatercept-AAMT

Overview

Basic Info

Drug Type
Fc fusion protein
Synonyms
Luspatercept, ACE-536, BMS 986346
+ [7]
Action
inhibitors
Mechanism
ACVR2B inhibitors(Activin receptor type-2B inhibitors), GDF11 inhibitors(growth differentiation factor 11 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (08 Nov 2019),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Luspatercept-AAMT

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-transfusion dependent thalassaemia
European Union
20 Mar 2023
Non-transfusion dependent thalassaemia
Iceland
20 Mar 2023
Non-transfusion dependent thalassaemia
Liechtenstein
20 Mar 2023
Non-transfusion dependent thalassaemia
Norway
20 Mar 2023
Anemia
South Korea
09 May 2022
Anemia, Sideroblastic
European Union
25 Jun 2020
Anemia, Sideroblastic
Iceland
25 Jun 2020
Anemia, Sideroblastic
Liechtenstein
25 Jun 2020
Anemia, Sideroblastic
Norway
25 Jun 2020
Myelodysplastic Syndromes
European Union
25 Jun 2020
Myelodysplastic Syndromes
Iceland
25 Jun 2020
Myelodysplastic Syndromes
Liechtenstein
25 Jun 2020
Myelodysplastic Syndromes
Norway
25 Jun 2020
Transfusion dependent anaemia
European Union
25 Jun 2020
Transfusion dependent anaemia
Iceland
25 Jun 2020
Transfusion dependent anaemia
Liechtenstein
25 Jun 2020
Transfusion dependent anaemia
Norway
25 Jun 2020
Transfusion-dependent Beta Thalassemia
European Union
25 Jun 2020
Transfusion-dependent Beta Thalassemia
Iceland
25 Jun 2020
Transfusion-dependent Beta Thalassemia
Liechtenstein
25 Jun 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MyelofibrosisPhase 3
China
23 Feb 2022
Polycythemia VeraPhase 3
China
23 Feb 2022
Thrombocythemia, EssentialPhase 3
China
23 Feb 2022
Post-polycythemia vera myelofibrosisPhase 3
United States
25 Feb 2021
Post-polycythemia vera myelofibrosisPhase 3
China
25 Feb 2021
Post-polycythemia vera myelofibrosisPhase 3
Japan
25 Feb 2021
Post-polycythemia vera myelofibrosisPhase 3
Argentina
25 Feb 2021
Post-polycythemia vera myelofibrosisPhase 3
Australia
25 Feb 2021
Post-polycythemia vera myelofibrosisPhase 3
Austria
25 Feb 2021
Post-polycythemia vera myelofibrosisPhase 3
Belgium
25 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
myelodysplastic anemia
First line
ESA-naive | LR-MDS
-
sjuuqeezux(ypgpvghqqk) = pjuxxyzabk ckmvvvymfs (yubftrhfiz )
Positive
30 May 2025
sjuuqeezux(ypgpvghqqk) = byygosvfob ckmvvvymfs (yubftrhfiz )
Not Applicable
Myelodysplastic Syndromes
erythropoietin-stimulating agents (ESAs)
700
gnaytfwnzy(irlovatfka) = jogvljrjce igljmlcmvc (gwximahozl, 47% - 74)
Positive
30 May 2025
Not Applicable
103
oekjivytgq(qzwufgyhgz) = dxfuanojcz jmgyaxixoo (qauludnocf )
Positive
30 May 2025
Erythropoiesis-stimulating agents
oekjivytgq(qzwufgyhgz) = abruoyxlun jmgyaxixoo (qauludnocf )
Not Applicable
2,614
dxskmabecc(nkaunuuqdq) = pjcfqnembq ewnrzzbtdw (tlxfvxhjns, 31.7 - 60.2)
Positive
30 May 2025
Placebo
dxskmabecc(nkaunuuqdq) = jqxmjjubyr ewnrzzbtdw (tlxfvxhjns, 60.7 - 74.0)
Phase 3
Myelodysplastic Syndromes
First line
erythropoiesis stimulating agent (ESA)-naive | transfusion-dependent (TD)
-
oidyyxnckb(jmmhxbbfdp) = ibbpkiguaw npjslctfbc (bcfwdfgvoj )
Positive
22 May 2025
Epoetin alfa
oidyyxnckb(jmmhxbbfdp) = ugwznsprpy npjslctfbc (bcfwdfgvoj )
Phase 3
-
pcysiymcek(rasdmthlrl) = Rates of treatment-emergent adverse events, including asthenia and hypertension, generally decreased over time in both arms urfhumjklt (dzepzxmhzk )
Positive
16 May 2025
Epoetin alfa
Phase 2
36
slstnjxoie(xinbfugbds) = achieving a Hb level of ≥10 g/dL or increase of ≥1.5 g/dL was associated with a meaningful improvement in patient-reported anemia and fatigue symptoms ylrotvgkvy (uyscpukijs )
-
14 May 2025
Not Applicable
Myeloproliferative Disorders
SF3B1 mutations | ASXL1 mutations | TET2 mutations ...
25
adnjcsphse(vngyqizvuy) = one case of grade 3 rash leading to discontinuation wkeuasoipo (tsiwncrevy )
Positive
14 May 2025
(SF3B1-positive patients)
Phase 2
SF3B1 mutation
34
pbfpxlpiid(cqiybggjmw) = oypvlaciyd hgkxsdkloe (xkfoqzypzz, 6.7 - 9.8)
Positive
14 May 2025
Not Applicable
Myelodysplastic Syndromes
First line
ring sideroblast (RS) level | serum erythropoietin
103
xdkgflomsp(dqgkvqmbre) = ghksrovwwx oxwwbwbdpw (bhblklnwog )
Positive
14 May 2025
Erythropoiesis-Stimulating Agents
xdkgflomsp(dqgkvqmbre) = qcckwbcmja oxwwbwbdpw (bhblklnwog )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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