Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Irafamdastat · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Treatment E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Irafamdastat | DRUG | Specified dose on specified days. |
Inclusion Criteria: * Healthy male or non-pregnant and non-nursing female (as assigned at birth). * BMI between 18.0 and 33.0 kg/m2, inclusive. Exclusion Criteria: * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or cli...
Irafamdastat is an investigational small molecule drug being developed by Bristol-Myers Squibb Company (ticker: BMY). It is currently in Phase 1 clinical development and is being studied in healthy adult volunteers, not in patients with a specific disease. It has not been approved by the FDA.
Irafamdastat is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor of the Phase 1 study evaluating the drug in healthy adult participants.
Irafamdastat is in Phase 1 clinical development. One Phase 1 trial has been registered and is currently active, with a planned enrollment of 24 participants. No Phase 2 or later trials have been registered, and the drug is investigational rather than approved.
Irafamdastat is being studied in one registered Phase 1 trial, NCT07837115, titled a study to assess the relative bioavailability of Irafamdastat (BMS-986368) and to assess the food effect on its pharmacokinetics in healthy adult participants. The trial is not yet recruiting, is controlled and randomized, and plans to enroll 24 participants in the United States.
Yes, Irafamdastat is also known as BMS-986368. Both names refer to the same investigational small molecule drug being developed by Bristol-Myers Squibb Company. The Phase 1 trial registered as NCT07837115 lists the drug under both names.
Irafamdastat is not yet used to treat any condition. It is an investigational drug in Phase 1 testing, and the only registered trial studies it in healthy adult volunteers to assess relative bioavailability and the effect of food on its pharmacokinetics. No approved indication exists for Irafamdastat.