drugset / Trial / NCT05490446
A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2022-11-07
- Primary completion
- 2026-03-17
- Completion
- 2029-03
Outcome
Missed primary endpoint
release “This decision follows results from its Phase 2b trial that did not meet the company’s predefined threshold to support further development in this indication.” agios.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tebapivat | Small molecule | 5 mg | Oral |
| Subject | Tebapivat | Small molecule | 10 mg | Oral |
| Subject | Tebapivat | Small molecule | 15 mg | Oral |
| Subject | Tebapivat | Small molecule | 20 mg | Oral |