Trials / Active Not Recruiting

Active Not RecruitingNCT05490446

A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)

A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Open-label (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 87 (actual)

Sponsor: Agios Pharmaceuticals, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This purpose of this study is to establish proof of concept of tebapivat in participants with LR-MDS in Phase 2a and to evaluate the effect of tebapivat on transfusion independence (TI) in participants with LR-MDS in phase 2b.

Conditions

Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Tebapivat	Tebapivat Tablet

Timeline

Start date: 2022-11-07
Primary completion: 2026-03-01
Completion: 2029-03-01
First posted: 2022-08-05
Last updated: 2026-03-30

Locations

45 sites across 13 countries: United States, Australia, Austria, Czechia, France, Germany, Greece, Israel, Italy, Poland, South Korea, Spain, United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05490446. Inclusion in this directory is not an endorsement.