Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-151607 · 1 trial · 1 indication
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
| Arm | Type | Description |
|---|---|---|
| AGN-151607 (250 U) | EXPERIMENTAL | Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| AGN-151607 (125 U) | EXPERIMENTAL | Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | PLACEBO_COMPARATOR | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Name | Type | Description |
|---|---|---|
| AGN-151607 | DRUG | Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
| Placebo | DRUG | Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. |
Inclusion Criteria: Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form. * Written informed consent from the participant has been obtained prior to any study-related procedures * Writt...
AGN-151607 is an investigational small molecule being developed for the prevention of post-operative atrial fibrillation in adult patients undergoing open-chest cardiac surgery. It is currently in Phase 2 clinical development and has not been approved by the FDA.
AGN-151607 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the drug for the prevention of post-operative atrial fibrillation.
AGN-151607 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval.
AGN-151607 was studied in a completed Phase 2 trial with the identifier NCT03779841, known as the NOVA trial. This randomized, double-blind, placebo-controlled study enrolled 323 participants across the United States, Austria, Canada, Germany, Italy, Netherlands, Spain, Sweden, and the United Kingdom.
AGN-151607 is a form of botulinum toxin type A. The Phase 2 trial NCT03779841 evaluated botulinum toxin type A (AGN-151607) for the prevention of post-operative atrial fibrillation in adults undergoing open-chest cardiac surgery.