Enrollment Begins for Elritercept Phase 3 Trial in Lower-Risk MDS

The first patient globally has been enrolled in the phase 3 TAK-226-3001 trial (NCT07422480) evaluating elritercept (TAK-226) vs epoetin alfa-epbx (Epogen) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes (MDS), according to a news release from King’s College Hospital NHS Foundation Trust.¹ King’s College Hospital in London enrolled the first patient and is one of 2 UK sites taking part in the global study, which plans to enroll a population of 300 patients who may remain in the trial for up to 5 years.

What is the TAK-226-3001 trial evaluating?

TAK-226-3001 is a phase 3 study comparing the safety and efficacy of elritercept, an investigational agent, vs epoetin alfa, an erythropoiesis-stimulating agent (ESA), for the treatment of anemia in adults with very low–, low–, or intermediate-risk MDS who require regular red blood cell transfusions. The trial aims to establish whether elritercept reduces the need for red blood cell transfusions and how its safety compares with epoetin alfa. Additional end points include assessing patient-reported fatigue, transfusion burden, quality of life, and the extent of the immune response to therapy.²

Patients 18 years and older with a documented diagnosis of MDS per WHO 2016 classification, bone marrow with less than 5% blasts in an evaluable bone marrow collected at screening, and requirement of a red blood cell transfusion are eligible for enrollment. Having an ECOG performance status of 0 to 2 is another requirement for study entry. Those who have prior treatment with agents including epoetin alfa, darbepoetin alfa (Aranesp), immunomodulatory drugs, or hypomethylating agents are ineligible for enrollment.

What did King’s College Hospital announce?

King’s College Hospital, a National Reference Centre for MDS, enrolled the world’s first patient in the trial with support from the National Institute for Health and Care Research (NIHR) Clinical Research Facility at King’s. The trust reported that recruitment occurred ahead of national targets introduced in April 2026 to accelerate clinical trial setup in the UK.

“King’s College Hospital is a National Reference Centre for MDS, and patients are referred to us for cutting-edge clinical trials to improve their outcomes and quality of life,” said Austin Kulasekararaj, MD, consultant hematologist at King’s and chief investigator of the study, in the news release.¹ “The only approved treatment in the UK for ‘lower risk’ MDS is supportive treatment with erythropoietin (natural hormone) injections and if this fails, patients start needing blood transfusions. This trial could provide a fantastic opportunity for our patients to benefit from this therapy.”

What is elritercept and how does it work?

Elritercept is a modified activin receptor type IIA ligand trap designed to inhibit select transforming growth factor-β (TGF-β) superfamily ligands, including activin A, to promote red blood cell and platelet production across multiple stages of hematopoiesis.³ It is administered as a subcutaneous injection. Takeda gained rights to elritercept through a licensing agreement with Keros Therapeutics in December 2024 and is developing the agent for anemia associated with hematologic malignancies, including MDS.⁴

“The King’s [clinical research facility] is thrilled to have recruited the very first [patient] to an important study helping to treat this rare disease. A special thank you to our research nurse, Tamera Osei-Mintah, and the entire [clinical research facility] team for their hard work and relentless determination. Their ability to set up and recruit to this study so rapidly is a fantastic achievement,” Elka Giemza, clinical research facility manager at King’s College, concluded.¹

References

1. King’s recruits world’s first patient for rare blood cancer trial. News release. King’s College Hospital NHS Foundation Trust. September 7, 2026. Accessed September 8, 2026. https://tinyurl.com/mthmefvd
2. A study to compare elritercept with epoetin alfa to treat anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular blood transfusions (ELRiSE MDS). ClinicalTrials.gov. Updated July 22, 2026. Accessed September 8, 2026. https://tinyurl.com/8eye34eb
3. Lachey J, Rovaldi C, Bobba S, et al. Elritercept, a modified activin receptor IIA ligand trap, increased erythropoiesis and thrombopoiesis in a phase 1 trial. Blood Adv. 2025;9(1):193-201. doi:10.1182/bloodadvances.2024014172
4. Takeda strengthens oncology pipeline with elritercept through licensing agreement with Keros Therapeutics. News release. Takeda Pharmaceutical Company Limited. December 3, 2024. Accessed September 8, 2026. https://tinyurl.com/pmvxezbd