Drugs / Tebapivat
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06745271 | Dec 2024 → Feb 2025 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04536792 | Jul 2020 → Dec 2023 | sickle cell disease | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06924970 | May 2025 → May 2026 overdue | sickle cell disease | Agios Pharmaceuticals, Inc. | Active not recruiting | Met primary |
| Phase 2 | NCT05490446 | Nov 2022 → Mar 2026 overdue | myelodysplastic syndrome | Agios Pharmaceuticals, Inc. | Active not recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-07-30 | Agios Pharmaceuticals, Inc. | Results Agios Reports Second Quarter 2026 Financial Results and Provides Business Update agios.com ↗
Agios announced that it will not advance tebapivat in LR-MDS following results from the company's Phase 2b trial. |
| 2026-07-21 | Agios Pharmaceuticals, Inc. | Results Agios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell Disease agios.com ↗
Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced topline results from the Phase 2 trial of tebapivat, an oral pyruvate kinase (PK) activator, in patients aged 16 years or older with sickle cell disease. |
| 2026-05-29 | Agios Pharmaceuticals, Inc. | Results Agios Provides Update on Phase 2b Trial of Tebapivat in Lower-Risk Myelodysplastic Syndromes agios.com ↗
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. |
| 2024-10-31 | Agios Pharmaceuticals, Inc. | Regulatory Agios Reports Business Highlights and Third Quarter 2024 Financial Results agios.com ↗ |
| 2024-09-11 | Agios Pharmaceuticals, Inc. | Regulatory Agios Announces FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of Myelodysplastic Syndromes (MDS) agios.com ↗
“Receiving orphan drug designation for tebapivat in MDS underscores the importance of bringing new oral treatment options to patients suffering from this rare disease,” said Sarah Gheuens , M.D., Ph.D., chief medical officer and head R&D at Agios. |
| 2023-11-20 | Agios Pharmaceuticals, Inc. | Results Agios Announces Clinical Proof-of-Concept in Phase 2a Trial of AG-946 for the Treatment of Anemia in Lower-Risk Myelodysplastic Syndromes agios.com ↗
Four of the 10 patients with low transfusion burden (LTB) achieved the transfusion independence endpoint, and one of the 22 patients treated in the study achieved the hemoglobin response endpoint in the 16-week treatment (core) period. |
| 2022-11-03 | Agios Pharmaceuticals, Inc. | Results Agios Pharmaceuticals to Present Broad Set of Clinical and Translational Data in Chronic Hemolytic Anemias at 64th ASH Annual Meeting and Exposition agios.com ↗
New Data from Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts of Phase 1 Study of AG-946 in Healthy Volunteers Support Profile as Potent PK Activator and Initiation of Phase 2 Study in Myelodysplastic Syndromes (MDS)-associated Anemia |
| 2021-11-04 | Agios Pharmaceuticals, Inc. | Results Agios to Present Broad Set of Clinical and Translational Data in Chronic Hemolytic Anemias at 63rd ASH Annual Meeting and Exposition agios.com ↗
First Data from the Phase 1 Healthy Volunteer Study of AG-946 Show Dose-dependent Changes in ATP and 2,3-DPG |
| 2020-03-23 | Agios Pharmaceuticals, Inc. | Regulatory Agios Announces FDA Clearance of Investigational New Drug Application for AG-946, a Next-Generation PKR Activator agios.com ↗
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for AG-946, a next-generation pyruvate kinase-R (PKR) activator. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tebapivat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05490446 ↗ |
| Known as | AG-946 | “A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)” NCT05490446 ↗ |
| Modality | Small molecule | — CHEMBL5314542 ↗ |
| Route | Oral | “The purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration” NCT04536792 ↗ |