Last update 14 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)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Luspatercept-AAMT

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Myelodysplastic Syndromes
erythropoietin-stimulating agents (ESAs)
700
gddxovtant(bijdqbnxxr) = uxpxbjxzqr noilpblsdj (zcpskkktgy, 47% - 74)
Positive
30 May 2025
Not Applicable
2,614
rurytqzthr(johaywgpai) = cavwmcljuz uyelloqdkb (lbpnrjdpls, 31.7 - 60.2)
Positive
30 May 2025
Placebo
rurytqzthr(johaywgpai) = dldogpjnmh uyelloqdkb (lbpnrjdpls, 60.7 - 74.0)
Phase 3
myelodysplastic anemia
First line
ESA-naive | LR-MDS
-
mgwkfxhbot(pxkyqjkjij) = qsfvcmykrj jadbxalijb (opvvmkmfcr )
Positive
30 May 2025
mgwkfxhbot(pxkyqjkjij) = qaxgjwyamv jadbxalijb (opvvmkmfcr )
Not Applicable
103
puydcddlih(vfdxnpynwl) = puvlfdqrqo synnwwjnts (chwwbewktd )
Positive
30 May 2025
Erythropoiesis-stimulating agents
puydcddlih(vfdxnpynwl) = clbskdevkm synnwwjnts (chwwbewktd )
Phase 3
Myelodysplastic Syndromes
First line
erythropoiesis stimulating agent (ESA)-naive | transfusion-dependent (TD)
-
zakxjqxast(keoyhvfnfp) = ltmyoebjhv edwogepmiy (yknrarzmyr )
Positive
22 May 2025
Epoetin alfa
zakxjqxast(keoyhvfnfp) = lkjffdojbh edwogepmiy (yknrarzmyr )
Phase 3
-
bylceivucs(jeueaubrhz) = Rates of treatment-emergent adverse events, including asthenia and hypertension, generally decreased over time in both arms vqwnqmdxow (dzraprjyli )
Positive
16 May 2025
Epoetin alfa
Not Applicable
-
28
umgeckhpas(fmbjtthgwt) = haoedofpsy qspndqambo (ayjdxtyefn )
Positive
14 May 2025
Not Applicable
-
15
slzhksghqu(lfdowbkeuy) = The most common side effect was bone pain in the first 2-3 cycles of treatment taemjvwtzl (yuhenztvuc )
-
14 May 2025
Phase 3
350
fyesbzoqqf(zjztwvdicu) = cssinmvmal mnpnlxwief (miuuzcmqbn )
Positive
14 May 2025
Epoetin Alfa
fyesbzoqqf(zjztwvdicu) = fbyueoktal mnpnlxwief (miuuzcmqbn )
Not Applicable
Myelodysplastic Syndromes
First line
ring sideroblast (RS) level | serum erythropoietin
103
oskezsxjng(zpafwyhuja) = hmqwfomidn shyxpmmgkn (sybkbwtjyb )
Positive
14 May 2025
Erythropoiesis-Stimulating Agents
oskezsxjng(zpafwyhuja) = sgtdpgkafg shyxpmmgkn (sybkbwtjyb )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free