NCT05490446Phase 2Active not recruiting

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

Study sponsor: Agios Pharmaceuticals, Inc. · AGIO

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-03-17Actual

Enrollment · participants87Actual

Source updated2026-09-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-04-24 · 2 fields changed

Completion date type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Primary completion date

Recorded edit

− Previous value

2026-03

+ Updated value

2026-03-17

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Posted 2025-12-03 · 4 fields changed

Participant count type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit

− Previous value

count: 82; type: ESTIMATED

+ Updated value

count: 87; type: ACTUAL

Primary completion date

Recorded edit

− Previous value

2025-11

+ Updated value

2026-03

Recruitment status

Recorded edit

− Previous value

Recruiting

+ Updated value

Active not recruiting

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Study details

Conditions studied

Myelodysplastic Syndromes

Treatments or interventions studied

TebapivatDrugAlso known as AG-946

Primary outcomes · main study measures

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measure: Phase 2a: Proportion of Participants With Hemoglobin (Hb) Response; description: Hb response is defined as a ≥1.5-grams per deciliter (g/dL) increase from baseline in the average Hb concentration from Week 8 through Week 16.; timeFrame: Baseline, Week 8 through Week 16; measure: Phase 2a: Proportion of Participants With Transfusion Independence During the Core Period; description: Transfusion Independence is defined as transfusion-free for ≥8 consecutive weeks during the Core Period (participants With Low Transfusion Burden \[LTB\] only).; timeFrame: Up to 16 weeks; measure: Phase 2b: Proportion of Participants With Transfusion Independence; description: Transfusion independence, defined as transfusion-free for ≥8 consecutive weeks (TI8) during the Core Period.; timeFrame: Up to 24 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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