ACE-536

DRUG3 trials

Sponsors

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA, Celgene

Conditions

AnemiaBeta-ThalassemiaMyelofibrosisMyeloproliferative DisordersPost-Polycythemia Vera MyelofibrosisPrimary Myelofibrosis

Phase 1

Study of ACE-536 in Healthy Postmenopausal Women

CompletedNCT01432717

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAAnemia

Start: 2011-09-30End: 2012-10-31Updated: 2012-11-07

Phase 2

Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia

RecruitingNCT04143724

CelgeneBeta-Thalassemia

Start: 2019-11-07End: 2035-08-31Target: 99Updated: 2026-07-10

Phase 3

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

Active, not recruitingNCT04717414

CelgeneAnemia, Myelofibrosis, Myeloproliferative Disorders +2

Start: 2021-02-25End: 2032-08-18Updated: 2026-07-16

Related Papers

Safety data from the non-transfusion-dependent dose-confirmation cohort: A phase 2a study of luspatercept in pediatric patients with β-thalassemia

Blood2025-11-03

Predictive Biomarkers of Response to Luspatercept in Patients with Myelofibrosis- (MF) Associated Anemia: Biomarker Analysis from the ACE-536-MF-001 Study

Blood2023-11-021 citations

A Phase 2a Study Evaluating the Safety and Pharmacokinetics (PK) of Luspatercept in Pediatric Patients with Transfusion-Dependent β-Thalassemia (TDT)

Blood2021-11-051 citations