Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Otamixaban · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion | EXPERIMENTAL | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide) |
| Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion | EXPERIMENTAL | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide) |
| UFH + Eptifibatide | ACTIVE_COMPARATOR | From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion) |
| Otamixaban Dose 1 | EXPERIMENTAL | dosage regimen 1 |
| Otamixaban Dose 2 | EXPERIMENTAL | dosage regimen 2 |
| Otamixaban Dose 3 | EXPERIMENTAL | dosage regimen 3 |
| Otamixaban Dose 4 | EXPERIMENTAL | dosage regimen 4 |
| Otamixaban Dose 5 | EXPERIMENTAL | dosage regimen 5 |
| UFH/Eptifibatide | ACTIVE_COMPARATOR | - |
| Severe renal impairment population | EXPERIMENTAL | - |
| Moderate renal impairment population | EXPERIMENTAL | - |
| Mild renal impairment population | EXPERIMENTAL | - |
| Healthy population | EXPERIMENTAL | Healthy matched subjects |
| Name | Type | Description |
|---|---|---|
| Otamixaban | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for Otamixaban) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| UFH | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for UFH) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Eptifibatide | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Placebo (for Eptifibatide) | DRUG | Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
| Otamixaban (XRP0673) | DRUG | intravenous administration |
| unfractionated heparin | DRUG | intravenous administration |
| Percutaneous Coronary Intervention | PROCEDURE | - |
Inclusion criteria: Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with: 1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, AND 2. One of the two following criteria: * New ST-segment depression ≥ 0.1 mV (≥1 mm), ...
Otamixaban is an investigational small molecule being developed for use in percutaneous coronary intervention, coronary disease, renal impairment, and acute coronary syndrome. It has been studied in patients undergoing non-urgent percutaneous coronary intervention, those with non-ST elevation acute coronary syndrome, and those with unstable angina or non-ST elevation myocardial infarction undergoing early invasive strategy.
Otamixaban is a small molecule that acts as a direct factor Xa inhibitor, targeting the coagulation cascade to prevent blood clot formation. By inhibiting factor Xa, it reduces thrombin generation and platelet activation, which is relevant in coronary artery disease and acute coronary syndrome settings.
Otamixaban is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi has conducted clinical trials of Otamixaban across multiple countries and phases to evaluate its safety and efficacy in cardiovascular and renal impairment indications.
Otamixaban is in Phase 1 of clinical development, according to the latest available data. It has completed Phase 2 and Phase 3 trials, but the current phase designation is Phase 1, indicating ongoing early-stage investigation. It is not FDA approved and remains an investigational drug in clinical development.
Otamixaban has been studied in four completed clinical trials. These include NCT00133731 (SEPIA-PCI trial in percutaneous coronary intervention), NCT00317395 (non-ST elevation acute coronary syndrome), NCT01076764 (unstable angina/non-ST elevation myocardial infarction), and NCT01120314 (renal impairment pharmacokinetic study). All trials are completed with no active trials ongoing.
Otamixaban is not known to have alternative names. It is a distinct investigational compound developed by Sanofi. In clinical trials, it has been compared to standard treatments such as unfractionated heparin and eptifibatide, but it is not the same as those drugs.