Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bendavia · 1 trial · 2 indications
Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
| Arm | Type | Description |
|---|---|---|
| Bendavia™ | ACTIVE_COMPARATOR | Bendavia™ administered intravenously at 0.05 mg/kg/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered intravenously at 60 mL/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel. |
| Name | Type | Description |
|---|---|---|
| Bendavia (MTP-131) | DRUG | 0.05 mg/kg/hr |
| Placebo | DRUG | Identically appearing placebo |
Inclusion Criteria: * Age ≥18 and \<85 years * The patient presents with first-time acute, anterior wall STEMI scheduled to undergo primary PCI and stenting. * The patient has symptoms of cardiac ischemia of ≥10 minutes. * The patient must demonstrate an anterior wall STEMI with \>0.1 millivolt (mV...
Bendavia is an investigational small molecule being developed for reperfusion injury, specifically for patients with acute coronary events such as ST-elevation myocardial infarction (STEMI). It is intended to reduce myocardial damage that occurs when blood flow is restored after a period of ischemia.
Bendavia is being developed by Icon Plc, a company traded on the NASDAQ under the ticker ICLR. The drug is currently in clinical development and has not been approved for commercial use.
Bendavia is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug. It has not received FDA approval and is still being studied for safety and efficacy in patients with reperfusion injury.
Bendavia has been studied in one completed Phase 2 clinical trial, identified as NCT01572909. This trial evaluated the effects of Bendavia on myocardial reperfusion injury in patients with acute coronary events, including STEMI, and enrolled 300 participants across the United States, Germany, Hungary, and Poland.
Yes, Bendavia is also known as MTP-131. The clinical trial NCT01572909 refers to the drug as MTP-131, and it is the same investigational compound being developed for reducing reperfusion injury in patients with acute coronary events.