Drugs / Luspatercept
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | REBLOZYL | — | 2023-08-28 | fda.gov ↗ |
| Approved | EU (EMA) | Reblozyl | — | 2020-06-25 | europa.eu ↗ |
| Approved | US (FDA) | REBLOZYL | — | 2019-11-08 | fda.gov ↗ |
Trials 48 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01432717 | Sep 2011 → Sep 2012 | anemia | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07663864 | Jun → Dec 2026 expected | aregenerative anemia | Guangdong Second Provincial General Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07362095 | Oct 2025 → Dec 2027 expected | acute leukemia | Zhujiang Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05181735 | May 2022 → Dec 2028 expected | myelodysplastic syndrome | Groupe Francophone des Myelodysplasies | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04539236 | Nov 2021 → Aug 2029 | myelodysplastic syndrome | Mikkael Sekeres MD | Suspended | No outcome recorded |
| Phase 225 trials | ||||||
| Phase 2 | NCT07463820 | Jun 2026 → Dec 2027 expected | myelodysplastic syndrome | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07450313 | Mar 2026 → Jun 2027 expected | disease related to hematopoietic stem cell transplant | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07331818 | Jan 2026 → Sep 2028 expected | erythrocyte disorder | EuroBloodNet Association | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07096297 | Dec 2025 → Aug 2030 expected | myelodysplastic syndrome | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06788691 | Mar 2025 → Feb 2027 expected | anemia, clonal hematopoiesis, neutropenia, thrombocytopenia | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT06517875 | Feb 2025 → Mar 2027 expected | myelofibrosis, primary myelofibrosis | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 2 | NCT05564390 | Jun 2024 → May 2029 expected | acute myeloid leukemia with multilineage dysplasia, myelodysplastic syndrome, therapy related acute myeloid leukemia and myelodysplastic syndrome | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06113302 | Mar 2024 → Jun 2028 expected | myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05925504 | Jul 2023 → Jun 2026 overdue | myelodysplastic syndrome | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT05732961 | Feb 2023 → Mar 2026 overdue | anemia, myelodysplastic syndrome, myeloproliferative neoplasm | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05005182 | Feb → Apr 2023 | myelodysplastic/myeloproliferative neoplasm | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2 | NCT05399732 | Dec 2022 → Feb 2025 | aplastic anemia | Bing Han | Completed | No outcome recorded |
| Phase 2 | NCT05664737 | Dec 2022 → Jul 2027 expected | anemia | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2 | NCT05924100 | Nov 2022 → Dec 2024 overdue | myelodysplastic syndrome associated with isolated del(5q) | Associazione Qol-one | Recruiting | No outcome recorded |
| Phase 2 | NCT05567458 | Oct 2022 → Aug 2025 overdue | beta thalassemia | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05384691 | Sep 2022 → Jul 2026 overdue | anemia, myelodysplastic syndrome | University of Leipzig | Recruiting | No outcome recorded |
| Phase 2 | NCT04477850 | Nov 2020 → Sep 2023 | myelodysplastic syndrome | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04143724 | Nov 2019 → Jan 2028 expected | beta thalassemia | Celgene Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT03900715 | May 2019 → Jul 2022 | myelodysplastic syndrome | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03342404 | Feb 2018 → Nov 2022 | thalassemia | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03194542 | Nov 2017 → Jul 2022 | primary myelofibrosis | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02268409 | Oct 2014 → Jun 2020 | beta thalassemia | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02268383 | Oct 2014 → Mar 2020 | myelodysplastic syndrome | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01749540 | Feb 2013 → Nov 2015 | beta thalassemia | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01749514 | Jan 2013 → Oct 2018 | anemia | Acceleron Pharma, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07636486 | Jun 2026 → Jun 2028 expected | engraftment syndrome, hematopoietic and lymphoid cell neoplasm | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07539779 | May 2026 → Jan 2030 expected | bone marrow failure syndrome, myelofibrosis | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT06927232 | Apr 2025 → Jan 2026 overdue | myelodysplastic syndrome | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05949684 | Oct 2023 → Mar 2028 expected | myelodysplastic syndrome | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06045689 | Oct 2023 → Oct 2025 overdue | myelodysplastic syndrome | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05181592 | Oct 2021 → Oct 2026 expected | myelodysplastic syndrome | GWT-TUD GmbH | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04717414 | Feb 2021 → May 2025 overdue | myelofibrosis, primary myelofibrosis | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04064060 | Aug 2019 → May 2028 expected | beta thalassemia, myelodysplastic syndrome, myelofibrosis | Celgene Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT03682536 | Jan 2019 → Mar 2023 overdue | myelodysplastic syndrome | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02604433 | May 2016 → Jan 2021 | beta thalassemia | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02631070 | Feb 2016 → Jun 2019 | myelodysplastic syndrome | Celgene Corporation | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06424639 | May 2024 → May 2025 | aplastic anemia | Peking Union Medical College Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT06006949 | Aug 2023 → Aug 2024 | myelodysplastic syndrome | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05891249 | Jun 2023 → Dec 2028 expected | anemia | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05462548 | Jul 2022 → Feb 2023 | beta-thalassemia major | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06964971 | May 2025 → May 2027 expected | aplastic anemia | The First Affiliated Hospital of Zhejiang Chinese Medical University | Not yet recruiting | No outcome recorded |
| — | NCT06164821 | Jan 2024 | — | Hematology department of the 920th hospital | Unknown | No outcome recorded |
| — | NCT06254781 | May → Aug 2022 | ovarian granulosa cell tumor | University Health Network, Toronto | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07338344 Comparator | Feb 2026 → Dec 2027 expected | beta-thalassemia major | Rongrong Liu | Recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-03-25 | Bristol-Myers Squibb | Bristol Myers Squibb Announces New Prescription Drug User Fee Act Goal Date for Reblozyl® (luspatercept-aamt) Supplemental Biologics License Application bms.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Luspatercept | “Luspatercept (ACE-536)” NCT04717414 ↗45 |
| Known as | ACE-536 | “Luspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin...” NCT04064060 ↗6“An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese...” NCT03900715 ↗ “Luspatercept (ACE-536) is a novel fusion protein that blocks transforming growth factor beta (TGF β) superfamily inhibitors of erythropoiesis, giving rise to a promising new...” PMID 28870615 ↗ Sep 2017 “Eligible subjects will receive luspatercept (ACE-536): starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W).” NCT05924100 ↗ “Luspatercept (ACE-536)” NCT04717414 ↗ |
| Known as | BMS-986346 | “luspatercept (BMS-986346)” NCT03342404 ↗ |
| Known as | Luspatercept aamt | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039545 ↗ |
| Known as | Reblozyl | “Luspatercept (Reblozyl®) is an agent that stimulates the production of red blood cells and is used to treat anemia caused by β-thalassemia.” PMID 36505885 ↗ Dec 20224“Luspatercept(Reblozyl) combined with low-dose thalidomide” NCT07338344 ↗ “Drug: Luspatercept Injection [Reblozyl]” NCT05181735 ↗ “Luspatercept Injection [Reblozyl]” NCT05924100 ↗ |
| Action | Inhibit | “binding to transforming growth factor-β superfamily ligands and inhibiting signaling through transcription factors Smad 2/3” PMID 24715706 ↗ Apr 2014 |
| Modality | Protein / enzyme biologic | “ACE-536, a recombinant protein containing a modified activin receptor type IIB” PMID 24715706 ↗ Apr 2014 |
| Route | Subcutaneous | “given subcutaneously every 2 weeks” PMID 24715706 ↗ Apr 2014 |
| Target | GDF11 | “Luspatercept (and sotatercept), ligand traps that particularly inhibit GDF11, lead to RBC transfusion independence in 10% to 50% of lower-risk MDSs resistant to available...” PMID 30602619 ↗ Jan 2019 |
| Target | SMAD2 | “Luspatercept, a recombinant fusion protein that binds transforming growth factor β superfamily ligands to reduce SMAD2 and SMAD3 signaling, showed promising results in a phase 2 study.” PMID 31914241 ↗ Jan 2020 |
| Target | SMAD3 | “Luspatercept, a recombinant fusion protein that binds transforming growth factor β superfamily ligands to reduce SMAD2 and SMAD3 signaling, showed promising results in a phase 2 study.” PMID 31914241 ↗ Jan 2020 |