Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
otamixaban XRP0673 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Mild impairment | EXPERIMENTAL | Patients with mild hepatic impairment |
| Moderate impairment | EXPERIMENTAL | Patients with moderate impairment |
| Healthy subjects | EXPERIMENTAL | Matched healthy subjects |
| Name | Type | Description |
|---|---|---|
| otamixaban XRP0673 | DRUG | Pharmaceutical form: solution for injection Route of administration: intravenous |
Inclusion criteria: \- Subjects with hepatic impairment: * Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive * Stable chronic liver disease assessed by medical history, physical examin...
Otamixaban XRP0673 is an investigational small molecule drug developed by Sanofi. It is a Factor Xa inhibitor that has been studied in a Phase 1 clinical trial in patients with mild and moderate hepatic impairment. It is not approved for any indication and remains in clinical development.
Otamixaban XRP0673 targets Factor Xa, also known as F10, and acts as an inhibitor of this coagulation enzyme. By inhibiting Factor Xa, the drug is designed to interfere with the blood coagulation cascade. This mechanism is the basis for its investigation in hepatic impairment.
Otamixaban XRP0673 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this investigational drug.
Otamixaban XRP0673 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program has evaluated the drug in patients with hepatic impairment.
Otamixaban XRP0673 has been studied in one completed Phase 1 trial, NCT01126086, titled a pharmacokinetic, pharmacodynamic and tolerability study in patients with mild and moderate hepatic impairment. The trial enrolled 25 patients in the United States and is now completed.
Yes, otamixaban XRP0673 is also known as otamixaban. The two names refer to the same investigational Factor Xa inhibitor developed by Sanofi. Searches for either name lead to the same drug asset and clinical program.