RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Paediatric investigation plan (European Union)

Structure/Sequence

Sequence Code 37465

Source: *****

Clinical Trials associated with Luspatercept-AAMT

NCT07096297

/ Not yet recruitingPhase 2IIT

A Phase II Study of Luspatercept Plus Darbepoetin Alfa in SF3B1 Wild Type Lower-risk Myelodysplastic Syndromes

This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in SF3B1 wild type, lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level < 500 IU/L.

Start Date01 Sep 2025

Sponsor / Collaborator

Yale University

[+1]

NCT06964971

/ Not yet recruitingNot ApplicableIIT

Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical Study

The goal of this clinical trial is to learn whether Luspatercept alone or in combination with Deferasirox can promote hematopoietic function in patients with transfusion-dependent non-severe aplastic anemia, as well as to assess the safety and efficacy of this treatment approach.
The main questions it aims to answer is:
whether the combination therapy of Luspatercept and Deferasirox can improve hemoglobin levels in these patients.
Participants will receive Luspatercept every 3 to 5 weeks based on hemoglobin response, undergo complete blood counts every 1 to 3 weeks, and receive other necessary evaluations as required.

Start Date20 May 2025

Sponsor / Collaborator

Zhejiang Chinese Medical University

NCT07073690

/ Active, not recruitingNot Applicable

Real-World Treatment Patterns and Outcomes of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes (LR-MDS) in China ('REACH' Study)

The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-na?ve and received luspatercept treatment in China

Start Date18 Apr 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Luspatercept-AAMT

100 Translational Medicine associated with Luspatercept-AAMT

100 Patents (Medical) associated with Luspatercept-AAMT

252

Literatures (Medical) associated with Luspatercept-AAMT

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Healthcare resource utilization of patients with lower-risk myelodysplastic syndromes treated with luspatercept versus erythropoiesis-stimulating agents: a United States healthcare claims database study

Article

Author: Mohan, Manasi ; Yenikomshian, Mihran ; Huynh, Lynn ; Swanson, Ashley ; Tang, Derek ; Pinaire, Megan ; Slaff, Samantha ; Zanardo, Enrico ; Song, Rui ; Ball, Brian J. ; Gavrilov, Svetlana

OBJECTIVE:

This study compared the healthcare resource utilization (HRU) of patients with lower-risk myelodysplastic syndromes (LR-MDS) treated with luspatercept versus erythropoiesis-stimulating agents (ESAs).

METHODS:

This real-world retrospective cohort study used claims data from the Symphony Health Integrated Dataverse, a large nationally representative United States database, to identify patients with LR-MDS who initiated luspatercept or ESA between May 1, 2020, and June 30, 2022. Index date was defined as the date of the first claim for luspatercept or ESA. The follow-up period was from the index date to the earliest of the end of clinical activity or end of data availability. All-cause and MDS-related HRU were evaluated for both treatment cohorts and compared using generalized estimating equations with Poisson distribution and robust variance estimator.

RESULTS:

Overall, 243 and 3,515 patients were included in the luspatercept and ESA cohorts, respectively. Patients in both cohorts had a similar median (interquartile range [IQR]) age at index (luspatercept: 77.0 [70.0-79.0] years; ESA: 78.0 [72.0-79.0] years) and median (IQR) follow-up duration (luspatercept: 14.6 [10.4-22.6] months; ESA: 14.4 [9.5-20.9] months). Compared with patients treated with ESA, patients treated with luspatercept had a 26% lower rate of all-cause inpatient visits (adjusted incidence rate ratio [aIRR], 0.74; 95% confidence interval [CI], 0.58-0.93; p < .05) and a 31% lower rate of all-cause outpatient visits (aIRR, 0.69; 95% CI, 0.61-0.79; p < .001). The rate of MDS-related inpatient visits was also 25% lower among the patients treated with luspatercept versus ESA (aIRR, 0.75; 95% CI, 0.56-0.99; p < .05).

CONCLUSION:

This study showed that patients with LR-MDS treated with luspatercept required significantly less HRU than patients treated with ESA. Further research is warranted to evaluate the financial impact of this lower HRU burden.

31 Dec 2025·Hematology

Luspatercept for the treatment of lower-risk myelodysplastic syndrome with SF3B1 mutation: a real-world single-center research in China

Article

Author: Xiong, Youzhen ; Zhao, Yufei ; Zhou, Kang ; Zhao, Xin ; Li, Yuan ; Peng, Guangxin ; Hu, Xiangrong ; Fan, Huihui ; Li, Jianping ; Liu, Xu ; Xing, Lingxiao ; Hu, Jing ; Ye, Lei ; Zhang, Li ; Yang, Wenrui ; Liang, Weiru ; Zhang, Baohang ; Zhang, Fengkui ; Jing, Liping ; Kang, Rui ; Shi, Yimeng ; Yang, Yang

BACKGROUND:

Luspatercept, approved by the FDA and EMA for patients with transfusion-dependent lower-risk myelodysplastic syndrome (LR-MDS) unresponsive to erythropoiesis-stimulating agents (ESAs), lacks extensive real-world data, particularly in China.

METHODS:

We retrospectively analyzed 14 LR-MDS-SF3B1 patients treated with luspatercept for ≥12 weeks.

RESULTS:

Median age was 60 years (range 47-72); 42.9% were male. Before treatment, 78.6% were transfusion-dependent, and 42.9% had prior ESA therapy. At median 24-week follow-up (range 12-44), erythroid response rates were 71.43% (week 12), 75.00% (week 16), and 62.50% (week 24). Hemoglobin levels significantly improved at weeks 12 and 24 (P = 0.013, P = 0.005). No grade 3-4 adverse events occurred. Hematologic improvement-erythroid (HI-E) patients exhibited higher white blood cells, neutrophils, and reticulocytes at week 12 versus non-HI-E patients. Bone marrow analysis revealed erythroid hyperplasia in HI-E patients, with higher erythrocyte percentage (56.00% vs. 34.00%, P = 0.023), lower myeloid-to-erythroid ratio (0.60 vs. 1.59, P = 0.024), and increased polychromatic erythroblasts (19.50% vs. 10.00%, P = 0.034).

CONCLUSIONS:

Luspatercept demonstrated efficacy and safety in Chinese LR-MDSSF3B1 patients. Greater erythroid hyperplasia correlated with better clinical response.

01 Dec 2025·Current Hematologic Malignancy Reports

Emerging Therapeutic Approaches for Anemia in Myelofibrosis

Review

Author: Harrington, Patrick ; Palumbo, Giuseppe A ; Chifotides, Helen T ; Duminuco, Andrea ; Torre, Elena ; Bose, Prithviraj ; Vetro, Calogero

PURPOSE OF REVIEW:

In this review, we highlight conventional agents and novel emerging therapeutic strategies to treat anemia in MF.

RECENT FINDINGS:

Anemia is a common and challenging feature of myelofibrosis (MF). The pathobiology of anemia is multifactorial, including progressive bone marrow fibrosis, decreased erythropoiesis due to high hepcidin levels leading to iron sequestration in the reticuloendothelial system, hypersplenism, erythropoiesis inhibition by myelosuppressive JAK inhibitors (ruxolitinib, fedratinib), and others. MF-associated anemia has a negative impact on survival. Conventional agents to manage anemia include erythropoiesis-stimulating agents, danazol, corticosteroids, and immunomodulatory agents, but responses are infrequent and lack durability. Notable advancements have emerged in developing novel treatments for anemia in MF, including the regulatory approval of momelotinib (ACVR1/JAK1/2 inhibitor) in 2023 and development of novel promising agents targeting hemojuvelin and activins. Momelotinib and pacritinib (ACVR1/JAK2 inhibitor) are the preferred JAK inhibitors for patients with cytopenias (anemia, thrombocytopenia). Luspatercept and elritercept are activin receptor ligand traps, promoting erythroid maturation and late-stage erythropoiesis. Currently, luspatercept is being evaluated in a phase 3 trial (INDEPENDENCE™) for anemia in MF patients who are on a JAK2 inhibitor and require transfusions, and in a phase 2 trial (ODYSSEY) in combination with momelotinib in MF patients who are transfusion dependent, whether or not on a JAK inhibitor. Interim results of the RESTORE trial demonstrated that elritercept significantly decreased transfusions in MF patients. DISC-0974 is a first-in-class anti-hemojuvelin (positive hepcidin regulator) monoclonal antibody that decreased hepcidin expression, increased serum iron, and enhanced erythropoiesis in anemic patients with MF in a phase 1b/2 study. Burgeoning studies of novel anemia-targeted agents and combinations are significantly improving the quality of life and outcomes of patients with MF. The recent approval of momelotinib to treat MF with anemia and the emerging novel anemia-directed strategies in early and advanced clinical development have ushered in a new era in the treatment of MF-related anemia.

178

News (Medical) associated with Luspatercept-AAMT

11 Aug 2025

·www.globenewswire.com

FibroGen Announces Positive Type C Meeting with the FDA for Roxadustat in Patients with Anemia Associated with Lower-Risk Myelodysplastic Syndromes

FibroGen has reached agreement with the FDA on important design elements for a pivotal Phase 3 clinical trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden Company intends to file the Phase 3 protocol in the fourth quarter of 2025 Aug. 07, 2025 -- FibroGen, Inc. (NASDAQ: FGEN) today announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial. “We are very pleased with the feedback we received from the FDA regarding roxadustat in patients with LR-MDS and anemia with high transfusion burden. This indication, despite recent approvals, still represents a patient population with significant unmet need,” said Thane Wettig, Chief Executive Officer of FibroGen. “We believe roxadustat’s differentiated mechanism of action, favorable tolerability profile, and oral route of administration can potentially be an important addition to the treatment options for patients with high transfusion burden. We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of this year.” “Anemia is a major cause of morbidity and complications in patients with LR-MDS, especially those with high transfusion burden, and is often associated with poor quality of life and shortened survival. While we have recent approvals of injectable drugs for this indication, there is a significant unmet need for novel, effective oral agents for this patient population,” added Amer Zeidan, M.B.B.S, M.H.S., Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center, and the global principal investigator of the planned Phase 3 study. “Roxadustat has already shown promising efficacy in this group of patients in the post-hoc analysis of the MATTERHORN study, and I am glad we have agreed on a pathway with the regulators to explore the full potential of roxadustat in the upcoming Phase 3 trial. I am excited by the prospect of roxadustat potentially becoming a novel, safe, convenient, and effective therapy for LR-MDS patients with high transfusion burden. FibroGen requested the Type C meeting based on the findings of a post-hoc analysis of data from the Phase 3 MATTERHORN trial of roxadustat in anemia-associated with LR-MDS. In patients with high RBC transfusion burden at baseline (≥4 units over 8 weeks1), a pronounced treatment effect was observed: 36% (8/22) of patients achieved transfusion independence (TI) for ≥ 56 days on roxadustat vs 7% (1/15) of patients on placebo within 28 weeks (nominal p-value of 0.041). The planned Phase 3 trial will assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with LR-MDS. Alignment was reached with the FDA on the patient population (patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria. As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI. Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S, thereof 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS. Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

01 Aug 2025

·www.biopharmadive.com

Regeneron cancer bispecific rejected again; Allogene discloses trial death

Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenxthat you may have missed.Regeneron said two more of its new drugshit regulatory setbacks because of Food and Drug Administration inspection issues at a third-party manufacturing plant. The company received a complete response letter for its bispecific cancer antibody odronextamabin lymphoma on July 30, due to issues at an Indiana factory that Novo Nordisk recently acquired from Catalent. In addition, the FDA will delay a decision on an application for high-dose Eylea processed at that plant. The odronextamab setback will require Regeneron to refile its application. The FDA previously rejected another Regeneron bispecific antibody, now approved as Lynozyfic, in multiple myeloma because of third-party manufacturing issues. Jonathan GardnerAllogene Therapeutics is stopping use of an experimental immunosuppresive antibody called ALLO-647 following the death of a study participant, the company said Friday. ALLO-647 is part of a regimen meant to prepare patients for treatment with Allogenes donor-derived cell therapy for blood cancer, cema-cel. But the antibody has been associated in rare cases with severe viral infections and, in this instance, was deemed related to an adenovirus infection that triggered liver failure in a participant in Allogenes pivotal trial. Allogene has closed the study arm with ALLO-647 and wont use it in future trials. It will move forward with a standard two-drug immunosuppressive regimen often used in cancer cell therapy. Results from the pivotal trial are still expected next year, the company said.Ben FidlerBristol Myers Squibb boosted its revenue outlook for 2025 by $700 million, driven by higher-than-expected sales of its off-patent cancer drug Revlimid. The company now expects full-year sales to be between $46.5 and $47.5 billion, although that may not flow through to the bottom line because of the $1.5 billion it has spent this year to license a BioNTech cancer drug. The unexpectedly high $838 million in Revlimid sales in the second quarter were part of a broader overperformance by the company, which beat Wall Street consensus for both its old and new drug business lines. Sales of Eliquis, Opdivo and Reblozyl were higher than expected, although cell therapy Abecma and new psoriasis drug Sotyktu were below, according to Leerink Partners analyst David Risinger. Jonathan GardnerBiogen shares rose as much as 7% Thursday after the biotechnology companys latest earnings report surpassed Wall Street expectations. The company recorded $2.6 billion in revenue from April through the end of June, with $160 million coming from Leqembi, its closely watched drug for Alzheimers disease. Biogen also raised its forecasts for 2025 revenue and earnings per share. To Brian Abrahams, an analyst at the investment bank RBC Capital Markets, the results were indicative that Biogens efforts to turn around the business are starting to show. We see considerable room for upside, he wrote in a note to clients. Jacob BellShares of Argenx climbed by double digits following quarterly sales numbers for its autoimmune drug Vyvgart that handily topped investor expectations. According to Argenx, the companys multiple Vyvgart formulations combined to generate nearly $949 million in revenue between April and June, beating consensus estimates by more than $80 million. The blowout performance included impressive numbers across Vyvgarts approved indications and different versions, wrote William Blair analyst Myles Minter on Thursday. Leerink Partners Thomas Smith now projects more than $9 billion in combined peak yearly sales. Argenxs market value rose past $40 billion on the news. Ben Fidler '

Cell TherapyImmunotherapyDrug ApprovalClinical ResultFinancial Statement

31 Jul 2025

·www.fiercepharma.com

Bristol Myers touts commercial execution, reckons with recent clinical setbacks

After four failed phase 3 trials, Bristol Myers Squibb CEO Chris Boerner said a new chief medical officer represents "an opportunity for a refresh." Bristol Myers Squibb had a strong quarter, with key drugs old and new coming in either above or in line with Wall Street’s expectations.The New Jersey pharma’s $12.3 billion revenues in the second quarter handily beat analysts’ consensus by 7.7%. As a result, the company raised its full-year revenue outlook by $700 million at the midpoint, to a new range between $46.5 billion and $47.5 billion.Both legacy products, such as blood cancer drug Revlimid and Pfizer-partnered blood thinner Eliquis, and newer drugs, including heart disease med Camzyos and cell therapy Breyanzi, outperformed expectations during the period. Most notably, despite a 38% year-over-year decline, Revlimid’s $838 million haul during the quarter landed a surprising 40% above consensus.But investors’ attention remains focused on the schizophrenia drug Cobenfy, despite its small $35 million contribution to BMS’ top line in the second quarter.The number slightly beat analysts’ projection of $32 million, as BMS continues to see prescription growth. Still, the sales are far from the multibillion-dollar territory that BMS and industry watchers believe the novel antipsychotic could reach. Cobenfy is now tracking over 2,000 total weekly scripts in the U.S., BMS Chief Commercialization Officer Adam Lenkowsky told investors on a call Thursday.“As we previously communicated, we knew it was going to take time to change what’s been decades of entrenched prescribing behavior; and indeed, I think that’s been the case,” Lenkowsky said.BMS is expanding its community field force to increase reach and frequency because “it takes multiple calls to change physician behavior,” he said. Addressing a common question from doctors about how to switch from traditional meds, BMS is introducing peer-to-peer assistance and running a phase 4 switch study, which is expected to read out this year.Lenkowsky described a phased approach to Cobenfy’s expansion: first in the community setting, then to hospitals and, ultimately, new indications.However, Cobenfy recently failed as an adjunctive treatment in patients with inadequately controlled schizophrenia. BMS, having observed a numerical improvement and a positive sign through a post-hoc subgroup analysis of the Arise trial, has said it would talk with the FDA about a potential path forward.That discussion has not yet happened, and BMS continues to analyze the data, BMS’ chief medical officer, Samit Hirawat, M.D., said on Thursday’s call.Meanwhile, investors are shifting their focus to Cobenfy’s opportunity in Alzheimer’s disease psychosis, with Adept-2, the first of three phase 3 trials, on track to report data this year. BMS needs at least two positive studies to be able to file for an approval there.Cobenfy is a combination of xanomeline and trospium chloride. Xanomeline has shown some benefits for treating psychosis symptoms in Alzheimer’s, but as one analyst noted on Thursday’s call, xanomeline on its own demonstrated a clear problem with patient dropouts in an earlier trial. Hirawat argued that people should not draw direct conclusions from that case, because BMS’ trials mark “a huge difference” from the xanomeline study conducted 30 years ago.Counting Cobenfy’s Arise trial flop, all four of BMS’ pivotal data readouts so far this year have been negative. The other three setbacks were Opdualag in adjuvant melanoma, Camzyos in non-obstructive hypertrophic cardiomyopathy and, more recently, Reblozyl in myelofibrosis-associated anemia. Clinical failures of those growth products don’t look very promising for a company that’s bracing itself for a major loss-of-exclusivity phase. But BMS CEO Chris Boerner appeared less concerned.“First, as we look back at the studies that haven’t gone the way we had anticipated, there are two things I think are important to keep in mind,” Boerner said on the investor call. “The first is that when you look at those studies in totality, while they were meant to answer important scientific questions or clinical practice questions, they collectively have relatively limited impact on the long-term growth of the company.”“What is more important is whether or not those studies have any implications going forward,” the chief executive continued. “And we don’t see any read-forward from those studies to future opportunities.”That said, BMS is bringing on a new chief medical officer as of Aug. 1: Cristian Massacesi, M.D., formerly AstraZeneca’s chief medical officer and oncology chief development officer.“In many respects, not just with respect to the early pipeline, but really across drug development, there’s going to be a focus that we have on execution,” Boerner said of Massacesi’s appointment.While Hirawat has laid the foundation for some R&D initiatives at BMS, “anytime you bring somebody in from outside the company, you would expect that they would bring a different approach, a different level of energy, a different way of thinking,” Boerner continued. “So, I think there’s an opportunity for a refresh there as well.”

Phase 3Executive Change

100 Deals associated with Luspatercept-AAMT

External Link

KEGG	Wiki	ATC	Drug Bank
-	Luspatercept-AAMT	B03XA06	DB12281

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Non-transfusion dependent thalassaemia	European Union	Bristol-Myers Squibb Pharma EEIG	20 Mar 2023
Non-transfusion dependent thalassaemia	Iceland	Bristol-Myers Squibb Pharma EEIG	20 Mar 2023
Non-transfusion dependent thalassaemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	20 Mar 2023
Non-transfusion dependent thalassaemia	Norway	Bristol-Myers Squibb Pharma EEIG	20 Mar 2023
Anemia	South Korea	Bristol Myers Squibb Co.	09 May 2022
Anemia, Sideroblastic	European Union	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Anemia, Sideroblastic	Iceland	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Anemia, Sideroblastic	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Anemia, Sideroblastic	Norway	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Myelodysplastic Syndromes	European Union	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Myelodysplastic Syndromes	Iceland	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Myelodysplastic Syndromes	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Myelodysplastic Syndromes	Norway	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion dependent anaemia	European Union	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion dependent anaemia	Iceland	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion dependent anaemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion dependent anaemia	Norway	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion-dependent Beta Thalassemia	European Union	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion-dependent Beta Thalassemia	Iceland	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020
Transfusion-dependent Beta Thalassemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	25 Jun 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myelofibrosis	Phase 3	China	Celgene Corp.	23 Feb 2022
Polycythemia Vera	Phase 3	China	Celgene Corp.	23 Feb 2022
Thrombocythemia, Essential	Phase 3	China	Celgene Corp.	23 Feb 2022
Post-polycythemia vera myelofibrosis	Phase 3	United States	Celgene Corp.	25 Feb 2021
Post-polycythemia vera myelofibrosis	Phase 3	China	Celgene Corp.	25 Feb 2021
Post-polycythemia vera myelofibrosis	Phase 3	Japan	Celgene Corp.	25 Feb 2021
Post-polycythemia vera myelofibrosis	Phase 3	Argentina	Celgene Corp.	25 Feb 2021
Post-polycythemia vera myelofibrosis	Phase 3	Australia	Celgene Corp.	25 Feb 2021
Post-polycythemia vera myelofibrosis	Phase 3	Austria	Celgene Corp.	25 Feb 2021
Post-polycythemia vera myelofibrosis	Phase 3	Belgium	Celgene Corp.	25 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04717414 (Independence, NEWS) Manual	Phase 3	Anemia \| Myelofibrosis	-	Reblozyl	jqcczulios(muzbimedyq): P-Value = 0.0674 Not Met	Negative	18 Jul 2025
				Placebo
COMMANDS trial (ASCO2025)	Not Applicable	Myelodysplastic Syndromes First line	103	Luspatercept	aqhfsgutpb(ijizvgdsup) = nwmcqjjmxj wlalntgesg (lnxfrgvjft ) View more	Positive	30 May 2025
				Erythropoiesis-stimulating agents	aqhfsgutpb(ijizvgdsup) = nljdmoqzki wlalntgesg (lnxfrgvjft ) View more
ASCO2025	Not Applicable	Myelodysplastic Syndromes	2,614	Luspatercept	xyyeihgtwy(vyrtijflml) = cccgsnzhdh uwxctueood (dbrmxqmlcx, 31.7 - 60.2) View more	Positive	30 May 2025
				Placebo	xyyeihgtwy(vyrtijflml) = kveykeaoyw uwxctueood (dbrmxqmlcx, 60.7 - 74.0) View more
NCT03682536 (COMMANDS, ASCO2025)	Phase 3	myelodysplastic anemia First line ESA-naive \| LR-MDS	-	Luspatercept	kmtpsnetvo(juibqiftzn) = jscfmukgtv akvyeikzmm (zvdgumjjys ) View more	Positive	30 May 2025
				Epoetin alfa	kmtpsnetvo(juibqiftzn) = nrvnveoorn akvyeikzmm (zvdgumjjys ) View more
NCT03682536 (COMMANDS, EHA2025)	Phase 3	Myelodysplastic Syndromes First line erythropoiesis stimulating agent (ESA)-naive \| transfusion-dependent (TD)	-	Luspatercept	bufjsngadv(ubzjuqqntb) = ttihhwipde zbpuypotzl (rgwsaifdcp ) View more	Positive	22 May 2025
				Epoetin alfa	bufjsngadv(ubzjuqqntb) = iaffzmnkee zbpuypotzl (rgwsaifdcp ) View more
NCT03682536 (COMMANDS, Pubmed \| Adv Ther)	Phase 3	Myelodysplastic Syndromes	-	Luspatercept	gfstbfqapq(ilbuklrhjk) = Rates of treatment-emergent adverse events, including asthenia and hypertension, generally decreased over time in both arms egiivkbihr (tdywhttcqp ) View more	Positive	16 May 2025
				Epoetin alfa
PS2184 (EHA2025)	Not Applicable	-	107	Luspatercept	aqqelqramp(grzbsskscz) = 25, 23.4% dmqhtejibr (nqbpiwyfaw ) View more	-	14 May 2025
QOL-ONE PHOENIX (EHA2025)	Not Applicable	Transfusion dependent anaemia \| Myelodysplastic Syndromes	22	Luspatercept 1.0 mg/kg	tqldqrptqu(vcyxxkuhcq) = one non-responder died of pneumonia poplzjulwn (qbtplbsrpk ) View more	Positive	14 May 2025
ACE-536-MF-001 (EHA2025)	Phase 2	Myelofibrosis	36	Luspatercept	xrwvsjoolm(cnlauwrcun) = 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 rdipdjjcir (qqvfptgcln ) View more	-	14 May 2025
PB2756 (EHA2025)	Not Applicable	Myelodysplastic Syndromes First line ring sideroblast (RS) level \| serum erythropoietin	103	Luspatercept	kpcgdxrkqc(bptjxmaqte) = qdufdwcvao vwhuugfpsf (mlmtqtyiye )	Positive	14 May 2025
				Erythropoiesis-Stimulating Agents	kpcgdxrkqc(bptjxmaqte) = ttccalqjcn vwhuugfpsf (mlmtqtyiye )

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