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Elritercept

DRUG9 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: 160Updated: 2026-02-06
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: 2032-05-01Target: 225Updated: 2026-05-13
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 Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
RecruitingNCT07422480
TakedaAnemia, Myelodysplastic Syndrome
Start: 2026-05-21End: 2033-10-01Target: 300Updated: 2026-06-15
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
Not yet recruitingNCT07623161
TakedaAnemia, Myelofibrosis
Start: 2026-08-25End: 2034-03-30Target: 324Updated: 2026-06-03

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