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AG881 · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| AG-881 | EXPERIMENTAL | Participants will receive AG-881 10 mg, tablet orally, once in Period 1 followed by AG-881 50 mg, tablet orally, once in Period 2. Period 1 and Period 2 will be separated by a washout period of 20 days between doses. |
| 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 tablets. |
Inclusion Criteria: 1. Have provided voluntary written informed consent. 2. Adult male or female, 18 to 55 years of age, inclusive, at Screening. 3. Continuous nonsmoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study. 4. Have a...
AG-881 is an investigational small molecule being studied in acute myeloid leukemia (AML), myelodysplastic syndrome, and other advanced hematologic malignancies with an IDH1 and/or IDH2 mutation. It has also been studied in healthy participants for safety and pharmacokinetic evaluations. AG-881 is in Phase 1 clinical development.
AG-881 targets cancers that have an IDH1 and/or IDH2 mutation. It is being evaluated in patients with advanced hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome, that carry these mutations. The drug is designed to act on these specific genetic alterations.
AG-881 is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company. Agios is listed on the NASDAQ under the ticker symbol AGIO. The company is conducting clinical trials to evaluate the safety and efficacy of AG-881 in various patient populations.
AG-881 is in Phase 1 clinical development. All completed trials for AG-881 are Phase 1 studies. These trials have been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities for commercial use.
AG-881 has been studied in four completed Phase 1 clinical trials. NCT02492737 evaluated AG-881 in patients with advanced hematologic malignancies with an IDH1 and/or IDH2 mutation. NCT03960502 studied its safety and pharmacokinetics in healthy male participants. NCT04015687 examined its effect on lamotrigine pharmacokinetics in healthy adults, and NCT04145128 evaluated it in healthy Japanese and non-Asian participants.
AG-881 is also known as vorasidenib. The drug has been studied under the name AG-881 in clinical trials, and vorasidenib is the alternative name used for the same compound. Both names refer to the same investigational small molecule being developed by Agios Pharmaceuticals.