Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ivosidenib · 1 trial · 1 indication
AG-120 Area Under the Curve
AG-120 Maximum Plasma Concentration
| Arm | Type | Description |
|---|---|---|
| ivosidenib (AG-120) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ivosidenib (AG-120) | DRUG | A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects |
Inclusion Criteria: * Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years. * Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucas...
Ivosidenib is an investigational small molecule being studied in healthy subjects. It is not approved for any disease and remains in clinical development. The only completed trial evaluated its effects in healthy male volunteers.
Ivosidenib is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AGIO. The company sponsored the clinical trial of this investigational drug.
Ivosidenib is in Phase 1 clinical development. It is an investigational drug, not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.
Ivosidenib has one completed Phase 1 trial, NCT03071770, titled 'Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects.' The study enrolled 60 healthy male participants in the United States and was not randomized or blinded.
Yes, ivosidenib is also known as AG-120. The clinical trial NCT03071770 refers to the drug as AG-120 in its title, confirming that both names refer to the same investigational compound.