Drugs / Luspatercept
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed anemia 3 milestones | |||||
| Filed | US (FDA) | Reblozyl | anemia | 2023-07-27 | “The FDA accepted the supplemental Biologics License Application for Reblozyl , a first-in-class treatment option, to expand its current indication to include treatment of anemia” bms.com ↗ |
| Filed | EU (EMA) | Reblozyl | anemia | 2023-07-27 | “the European Medicines Agency (EMA) validated the Type II Variation Application for Reblozyl to expand its current indication to include ESA-naïve treatment of anemia” bms.com ↗ |
| Filed | Japan (PMDA) | Reblozyl | anemia | 2023-07-27 | “Japan’s Ministry of Health, Labour and Welfare accepted the New Drug Application for Reblozyl as a treatment of anemia in adult patients with MDS” bms.com ↗ |
| Filed beta-thalassemia and related diseases 2 milestones | |||||
| Filed | EU (EMA) | Reblozyl | beta-thalassemia and related diseases | 2021-12-03 | “the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia.” bms.com ↗ “The EMA also validated the Type II variation for Reblozyl for NTD beta thalassemia.” bms.com ↗ “regulatory filings of luspatercept and ozanimod in the U.S. and Europe.” bms.com ↗ |
| Filed | US (FDA) | Reblozyl | beta-thalassemia and related diseases | 2021-12-03 | “The FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl” bms.com ↗ “has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl” bms.com ↗ “regulatory filings of luspatercept and ozanimod in the U.S. and Europe.” bms.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 49
| 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 Stop: Business |
| Phase 225 trials · 2 met primary | ||||||
| Phase 2 | NCT07463820 | Dec 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 | 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 Stop: Enrollment |
| 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 | Active not recruiting | Met primary |
| 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 | Met primary |
| 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 · 3 met primary · 1 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT02604433 | May 2016 → Jan 2021 | beta thalassemia | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT02631070 | Feb 2016 → Jun 2019 | myelodysplastic syndrome | Celgene Corporation | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT07830004 | Nov 2026 → May 2031 expected | myelodysplastic syndrome | University Hospital, Grenoble | Not yet recruiting | No outcome recorded |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07338344 Comparator | Feb 2026 → Dec 2027 expected | beta-thalassemia major | Rongrong Liu | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2026-02-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Top-Line Results from Registrational Phase 2 Study of Luspatercept in Adults with Alpha (α)-Thalassemia bms.com ↗
The study also met all key secondary endpoints. |
| 2025-12-01 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASH 2025 Showcase Potential of Hematology Pipeline and Build Momentum for Next Generation Portfolio bms.com ↗
Clinical benefit of luspatercept in erythropoiesis-stimulating agent (ESA)-naive patients (pts) with early disease characteristics and very low-, low-, or intermediate-risk myelodysplastic syndromes (LR-MDS)-associated anemia: A post hoc analysis from the COMMANDS trial |
| 2025-07-18 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Topline Results from Phase 3 INDEPENDENCE Trial for Reblozyl® (luspatercept-aamt) in Adult Patients with Myelofibrosis-Associated Anemia bms.com ↗
Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl , in line with previous results from the Phase 2 trial ( NCT03194542 ). |
| 2024-05-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at ASCO & EHA from More Than 130 Studies Across 25 Diseases Supporting Expansion into New Indications, Demonstrating Long-Term Survival, and Highlighting Novel Modalities and Research Platforms bms.com ↗
Luspatercept improves hematopoiesis in lower-risk myelodysplastic syndromes (MDS): Comparative biomarker analysis of ring sideroblast-positive and -negative subgroups from the phase 3 COMMANDS study. |
| 2024-04-02 | Bristol-Myers Squibb | Regulatory European Commission Expands Approval of Bristol Myers Squibb’s Reblozyl® (luspatercept) to Include First-Line Treatment of Transfusion-Dependent Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (LR-MDS) bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl ® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). |
| 2024-02-23 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl ® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS) bms.com ↗ |
| 2023-12-09 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Primary Efficacy and Safety Analysis of the Phase 3 COMMANDS Trial of Reblozyl for Treatment of Anemia in Erythropoiesis Stimulating Agent-Naïve Patients with Lower-Risk Myelodysplastic Syndromes at ASH 2023 bms.com ↗
New data confirm findings consistent with interim analysis, reaffirming superior efficacy and significantly longer durability of response with Reblozyl ® (luspatercept-aamt) compared to epoetin alfa |
| 2023-11-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb’s First Disclosures and New Data at ASH 2023 Highlight Company’s Leadership and Progress in Cell Therapy, Targeted Protein Degradation and Novel Approaches in Hematology bms.com ↗
New data from the Phase 3 COMMANDS study evaluating Reblozyl ® (luspatercept-aamt), including results from the primary analysis and patient-reported outcomes, reinforce Reblozyl’s clinical benefit in erythropoiesis stimulating agent-naïve, myelodysplastic syndromes-related anemia |
| 2023-08-28 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions bms.com ↗ |
| 2023-05-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present First Results at ASCO and EHA from Phase 3 COMMANDS Study of Reblozyl® (luspatercept-aamt) in First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) bms.com ↗
Results from Phase 3 COMMANDS study, selected for ASCO’s official press program, show nearly twice as many patients treated with Reblozyl achieved superior transfusion independence with concurrent hemoglobin increase vs. epoetin alfa, including in clinically relevant subgroups |
| 2023-05-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023 bms.com ↗
demonstrated highly statistically significant and clinically meaningful improvement in patients with anemia associated with very low- to intermediate-risk myelodysplastic syndromes |
| 2023-05-01 | Bristol-Myers Squibb | Regulatory U.S. FDA Accepts for Priority Review Supplemental Biologics License Application and EMA Validates Application for Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) bms.com ↗
In the U.S., the FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023. |
| 2023-03-03 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval of Reblozyl® (luspatercept) for Anemia in Adult Patients with Non-Transfusion-Dependent Beta Thalassemia bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted full Marketing Authorization for Reblozyl ® (luspatercept), a first-in-class therapeutic option, for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia. |
| 2023-01-27 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Adult Patients with Anemia-Associated, Non-Transfusion-Dependent (NTD) Beta Thalassemia bms.com ↗
The CHMP adopted a positive opinion based on results from the pivotal Phase 2 BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia. |
| 2022-10-31 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Topline Results of Phase 3 COMMANDS Trial bms.com ↗
Reblozyl, the first erythroid maturation agent, met primary and key secondary endpoints in the first-line treatment of patients with very low/low/intermediate-risk myelodysplastic syndromes |
| 2022-06-03 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Withdraws Supplemental Biologics License Application (sBLA) for Reblozyl® (luspatercept-aamt) for Non-transfusion Dependent (NTD) Beta Thalassemia bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the company has withdrawn a supplemental biologics license application (sBLA) for Reblozyl ® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. |
| 2022-05-19 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASCO and EHA 2022 Highlight Progress in Transforming Treatment for Patients with Cancer and Blood Disorders bms.com ↗
Long-term data from pivotal MEDALIST and BELIEVE studies highlight continued benefit of Reblozyl (luspatercept-aamt) for patients with lower-risk myelodysplastic syndromes and transfusion-dependent beta thalassemia (ASCO/EHA). |
| 2022-03-25 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Announces New Prescription Drug User Fee Act Goal Date for Reblozyl® (luspatercept-aamt) Supplemental Biologics License Application bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl ® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. |
| 2021-12-03 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review supplemental Biologics License Application for Reblozyl® (luspatercept-aamt) in Adults with Non-Transfusion Dependent (NTD) Beta Thalassemia bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl ® (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. |
| 2021-06-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb and Acceleron Present First Results from Phase 2 BEYOND Study of Reblozyl® (luspatercept-aamt) in Adults with Non-Transfusion Dependent(NTD)Beta Thalassemia bms.com ↗
Results demonstrated that 77.7% of patients treated with Reblozyl achieved a hemoglobin increase (≥1.0 gram/deciliter) compared to 0% of patients in the placebo arm. |
| 2021-05-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Research at ASCO and EHA 2021 Featuring Novel Approaches and Demonstrating Significant Progress to Improve Survival in Cancer and Blood Disorders bms.com ↗
First disclosure of results from Phase 2 BEYOND study evaluating Reblozyl (luspatercept) plus best supportive care demonstrate first-in-class erythroid maturation agent’s potential in adults with non-transfusion-dependent beta (β)-thalassemia |
| 2020-06-26 | Bristol-Myers Squibb | Regulatory European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia bms.com ↗
Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of: |
| 2020-05-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb Research at ASCO Demonstrates Diverse Approaches in Treating Cancer to Improve Outcomes for Patients bms.com ↗
Longer-term RBC transfusion reduction in the Phase 3 MEDALIST study of luspatercept in patients with lower-risk MDS with ring sideroblasts (RS) |
| 2020-04-30 | Bristol-Myers Squibb | Regulatory Reblozyl (luspatercept) Receives Positive CHMP Opinion for the Treatment of Adults with Anemia in Beta Thalassemia and Myelodysplastic Syndromes bms.com ↗
Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of: |
| 2020-04-03 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) bms.com ↗
The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell (RBC) transfusions and have failed an erythropoiesis stimulating agent |
| 2020-03-26 | Bristol-Myers Squibb | Results New England Journal of Medicine Publishes Results from Pivotal Phase 3 BELIEVE Trial of Reblozyl (luspatercept-aamt) in Adult Patients With Beta Thalassemia bms.com ↗
Results demonstrate that treatment with Reblozyl provides significant reduction in transfusion burden for patients with beta thalassemia-associated anemia compared to placebo |
| 2020-01-09 | Bristol-Myers Squibb | Results New England Journal of Medicine Publishes Results of Pivotal Phase 3 Reblozyl® (luspatercept-aamt) MEDALIST Trial bms.com ↗
MEDALIST achieved a statistically significant improvement in the primary endpoint of red blood cell transfusion independence (RBC-TI) for 8 or more weeks during the first 24 weeks of the study. |
| 2019-12-09 | Bristol-Myers Squibb | Results Reblozyl® (luspatercept-aamt) Studies Evaluating Treatment of Anemia in Rare Blood Diseases Presented at American Society of Hematology (ASH) Annual Meeting bms.com ↗
Initial results from phase 2 study evaluating an investigational use of luspatercept-aamt in myelofibrosis-associated anemia showed promising clinical activity – companies plan to initiate pivotal, phase 3 study called INDEPENDENCE in 2020 |
| 2019-12-06 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl® (luspatercept-aamt) bms.com ↗
The agency has informed Bristol-Myers Squibb that the original Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for its supplemental Biologics License Application (“sBLA”) for Reblozyl will remain, without the requirement for an ODAC review. |
| 2019-12-03 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb and Acceleron Pharma Announce FDA Advisory Committee Will Review Reblozyl® (luspatercept-aamt) for Use in Patients With Myelodysplastic Syndromes bms.com ↗ |
All press releases naming this drug 30 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Luspatercept | “Luspatercept (ACE-536)” NCT04717414 ↗ |
| 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 |