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Also known as AG881 Formulation 1, AG881 Formulation 2
AG-881 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| AG881 | EXPERIMENTAL | AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression, development of other unacceptable toxicity or Investigator discretion |
| Name | Type | Description |
|---|---|---|
| AG881 | DRUG | AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression or development of other unacceptable toxicity |
Inclusion Criteria: Patients must be ≥18 years of age Patients must have documented IDH1 and/or IDH2 gene-mutated disease Patients must have an advanced hematologic malignancy with an IDH1 and/or IDH2 mutation Patient must be able to understand and willing to sign an informed consent Patients m...
AG-881 is an investigational oral small molecule being studied for the treatment of acute myeloid leukemia (AML) and other advanced hematologic malignancies that carry an IDH1 and/or IDH2 mutation. It is being developed by Agios Pharmaceuticals, Inc. and is currently in Phase 1 clinical development.
AG-881 targets mutant IDH1 and IDH2, enzymes encoded by the IDH1 and IDH2 genes. By inhibiting these mutant forms of IDH, the drug is designed to interfere with the abnormal metabolic pathway that drives certain hematologic malignancies, including AML with IDH mutations.
AG-881 is being developed by Agios Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol AGIO. Agios is a biopharmaceutical company focused on cellular metabolism and precision oncology, and AG-881 is one of its investigational IDH-targeted small molecule candidates.
AG-881 is in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational agent. The Phase 1 trial evaluating AG-881 in patients with advanced hematologic malignancies has been completed, with no active trials currently ongoing.
AG-881 has been evaluated in one completed Phase 1 trial, NCT02492737, titled "Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation." The trial enrolled 46 patients across the United States and France and included patients with AML, myelodysplastic syndrome, and other hematologic malignancies.
Yes. AG-881 is also known as AG881, AG881 Formulation 1, and AG881 Formulation 2. These names refer to the same investigational compound developed by Agios Pharmaceuticals, Inc. for IDH-mutant hematologic malignancies including acute myeloid leukemia.