Elritercept

DRUG10 trials

Sponsors

Takeda Development Center Americas Inc., Takeda

Conditions

AnemiaAnemia in Patients with Very LowCytopeniaLowMyelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic neoplasms/syndromes (MDS)Myelofibrosis

Phase 2

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

RecruitingNCT04419649

TakedaCytopenia, Myelodysplastic Syndromes

Start: 2020-08-19End: 2031-10-30Target: 210Updated: 2026-10-19

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

RecruitingNCT05037760

TakedaMyelofibrosis

Start: 2021-12-16End: 2030-02-28Target: 135Updated: 2026-02-05

A Phase 2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KER-050 as Monotherapy or in Combination with Ruxolitinib in Participants with Myelofibrosis.

Active, not recruitingCTIS2023-507468-38-00

Takeda Development Center Americas Inc.Myelofibrosis

Start: 2022-04-22Target: 47Updated: 2025-12-16

A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Active, not recruitingCTIS2023-507469-24-00

Takeda Development Center Americas Inc.Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS).

Start: 2022-04-30Target: 56Updated: 2025-12-17

Phase 3

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

RecruitingNCT06499285

TakedaMyelodysplastic Syndromes

Start: 2025-05-06End: 2032-03-05Target: 225Updated: 2026-10-23

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

RecruitingCTIS2024-516009-22-00

Takeda Development Center Americas Inc.myelodysplastic neoplasms/syndromes (MDS)

Start: 2025-04-30Target: 74Updated: 2025-09-01

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions

RecruitingNCT07422480

TakedaAnemia, Myelodysplastic Syndrome

Start: 2026-05-21End: 2033-10-01Target: 300Updated: 2026-10-19

A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

Not yet recruitingCTIS2025-523544-12-00

Takeda Development Center Americas Inc.Myelodysplastic neoplasms/syndromes (MDS)

Target: 16Updated: 2026-04-17

A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib

RecruitingNCT07623161

TakedaAnemia, Myelofibrosis

Start: 2026-09-10End: 2034-03-30Target: 324Updated: 2026-10-01

A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK‑226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy

Not yet recruitingCTIS2026-525660-17-00

Takeda Development Center Americas Inc.Myelofibrosis

Target: 42Updated: 2026-10-09

Related Papers

Hematological and clinical improvements with elritercept (KER-050, TAK-226) at the recommended Phase 2 dose (RP2D) in patients with myelofibrosis (MF) receiving ruxolitinib: Updated results from the Phase 2 restore trial

Blood2025-11-03

Elritercept shows durable responses in lower-risk myelodysplastic neoplasms (LR-MDS) with transfusion dependence: Updated Results from an ongoing Phase 2 trial

Blood2025-11-03

Hematological Improvement and Other Clinical Benefits of Elritercept As Monotherapy and in Combination with Ruxolitinib in Participants with Myelofibrosis from the Ongoing Phase 2 Restore Trial

Blood2024-11-0510 citations

Renew Trial in Progress: A Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Neoplasms (MDS)

Blood2024-11-052 citations

Hematologic Improvement and Fatigue Reduction with Elritercept (KER-050) in Participants with Lower-Risk (LR) Myelodysplastic Neoplasms (MDS) with Non-Transfusion Dependent Anemia: New Analyses from an Ongoing Phase 2 Trial

Blood2024-11-051 citations

Improvements in Hematological Parameters and Quality of Life (QOL) with Elritercept (KER-050): Results from an Ongoing Phase 2 Trial in Participants with Lower-Risk (LR) Myelodysplastic Neoplasms (MDS)

Blood2024-11-051 citations

Rker-050, a Modified Activin Receptor Type Iia Ligand Trap, Regulates Osteogenic Lineage, Complementing the Erythroid Response and Rebalancing the Osteo-Hematopoietic Niche

Blood2024-11-05

Elritercept, a modified activin receptor IIA ligand trap, increased erythropoiesis and thrombopoiesis in a phase 1 trial

Blood Advances2024-10-226 citations

Durable Clinical Benefit with Ker-050 Treatment: Findings from an Ongoing Phase 2 Study in Participants with Lower-Risk MDS

Blood2023-11-0211 citations

Modulation of TGF-β Superfamily Signaling By Ker-050 Demonstrated Potential to Treat Myelofibrosis and Mitigate Ruxolitinib-Associated Cytopenia

Blood2023-11-025 citations

Ker-050 Treatment Reduced Iron Overload and Increased Bone Specific Alkaline Phosphatase in Participants with Lower-Risk MDS Supporting Potential to Restore Balance to the Osteohematopoietic Niche

Blood2023-11-02

Modulation of TGF-β Superfamily Signaling to Treat Myelofibrosis and Mitigate JAK Inhibitor Toxicity: A Report on the Phase 2 Study of Ker-050 in Participants with Myelofibrosis

Blood2022-11-151 citations