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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 70 words Secondary endpoints: details revised at 4 of 33 entries · Site details revised at 2 of 45 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 4 of 33 entries
    • Site details revised at 2 of 45 sites
  2. 4 versions Re-verified since May 28, 2026, no change to tracked fieldsv40-v43
  3. Primary completion date changed from estimate of Mar 2026 to Mar 17, 2026v39
  4. 4 versions Re-verified since Dec 24, 2025, no change to tracked fieldsv35-v38
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 82 to confirmed 87 · Primary completion date: Nov 2025 to Mar 2026 · Completion date: Nov 2028 to Mar 2029 · 1 morev34 Show 4 more changesShow less
    • Enrollment target: estimated 82 to confirmed 87
    • Primary completion date: Nov 2025 to Mar 2026
    • Completion date: Nov 2028 to Mar 2029
    • Site details revised at 45 of 45 sites
Show 32 earlier versionsHide 32 earlier versions
  1. 5 versions Re-verified since Jun 19, 2025, no change to tracked fieldsv29-v33
  2. Site details revised at 1 of 45 sitesv28
  3. 2 versions Re-verified since Mar 20, 2025, no change to tracked fieldsv26-v27
  4. Site details revised at 1 of 45 sitesv25
  5. Site details revised at 6 of 45 sitesv24
  6. Site details revised at 7 of 45 sitesv23
  7. Site details revised at 8 of 45 sitesv22
  8. Site details revised at 14 of 45 sitesv21
  9. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 80 to 82 · Study sites: 44 to 45v20 Show 2 more changesShow less
    • Enrollment target: 80 to 82
    • Study sites: 44 to 45
  10. Enrollment target: 116 to 80 Primary endpoints revised (3) · Interventions: AG-946 (Drug), Placebo (Drug) to Tebapivat (Drug) · Eligibility criteria expanded, about 224 words · 3 morev19 Show 6 more changesShow less
    • Primary endpoints revised (3)
    • Interventions: AG-946 (Drug), Placebo (Drug) to Tebapivat (Drug)
    • Eligibility criteria expanded, about 224 words
    • Secondary endpoints: 32 to 33
    • Study arms: 8 to 4
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. 8 versions Re-verified since Oct 12, 2023, no change to tracked fieldsv11-v18
  12. Enrollment target: 22 to 116 Study sites: 38 to 44 · Primary completion date: May 2025 to Nov 2025 · Completion date: Nov 13, 2028 to Nov 2028 · 1 morev10 Show 4 more changesShow less
    • Study sites: 38 to 44
    • Primary completion date: May 2025 to Nov 2025
    • Completion date: Nov 13, 2028 to Nov 2028
    • Start date: Oct 20, 2022 to Nov 7, 2022
  13. Enrollment target: 21 to 22 Interventions: AG-946 (Drug), AG-946 (Drug), Placebo (Drug) to AG-946 (Drug), Placebo (Drug) · Eligibility criteria expanded, about 140 wordsv9 Show 2 more changesShow less
    • Interventions: AG-946 (Drug), AG-946 (Drug), Placebo (Drug) to AG-946 (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 140 words

    See this version in full on ClinicalTrials.gov ↗

  14. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 116 to confirmed 21 · Site details revised at 38 of 38 sitesv8 Show 2 more changesShow less
    • Enrollment target: estimated 116 to confirmed 21
    • Site details revised at 38 of 38 sites
  15. Study sites: 20 to 38v7
  16. Study sites: 5 to 20v6
  17. Study sites: 3 to 5v5
  18. Study sites: 1 to 3 Primary completion date: Nov 17, 2025 to May 2025v4 Show 1 more changeShow less
    • Primary completion date: Nov 17, 2025 to May 2025
  19. Start date changed from estimate of Sep 28, 2022 to Oct 20, 2022v3
  20. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Sep 15, 2022 to Sep 28, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Sep 15, 2022 to Sep 28, 2022
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05490446
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Myelodysplastic Syndromes
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov