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Also known as Idrabiotaparinux sodium, Biotinylated Idraparinux, SSR126517
Idrabiotaparinux · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Idrabiotaparinux | EXPERIMENTAL | Idrabiotaparinux sodium, 3.0 mg, once-weekly for 3 or 6 months depending on the stratum, after enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage). |
| Warfarin | ACTIVE_COMPARATOR | Warfarin, INR-adjusted dose, started 24 hours after the start of enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days, and continued for 3 or 6 months depending on the stratum. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage). |
| Idraparinux | ACTIVE_COMPARATOR | Idraparinux sodium, 2.5 mg, once-weekly for 6 months In avidin sub-study, participants receive on Day 183, placebo (for avidin) (4 hours after Idrabiotaparinux administration) |
| Name | Type | Description |
|---|---|---|
| Idrabiotaparinux sodium | DRUG | 0.5 mL pre-filled syringe for 3.0 mg Subcutaneous injection |
| Warfarin | DRUG | Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration |
| Placebo (for idrabiotaparinux sodium) | DRUG | 0.5 mL pre-filled syringe Subcutaneous injection |
| Avidin | DRUG | 100 mg in 10 mg/mL solution Intravenous infusion for 30 minutes |
| Placebo (for warfarin) | DRUG | Warfarin matching capsules Oral administration |
| Enoxaparin | DRUG | Prefilled syringes as locally registered Subcutaneous injection |
| Idraparinux sodium | DRUG | 0.5 mL pre-filled syringe for 2.5 mg Subcutaneous injection |
| Placebo (for Avidin) | DRUG | Avidin matching powder in 10 mg/mL solution Intravenous infusion for 30 minutes |
Inclusion Criteria: * Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis Exclusion Criteria: * End stage renal failure, hepatic failure, uncontrolled hypertension; * Active bleeding or high risk for bleeding; * Pregnancy or childbearing potential without proper contra...
Idrabiotaparinux is an investigational small molecule anticoagulant developed by Sanofi for cardiovascular conditions. It was studied in Phase 3 clinical trials for the treatment of deep venous thrombosis and embolism. It is also known as idrabiotaparinux sodium. It has not been approved by the FDA and remains a clinical-stage candidate.
Idrabiotaparinux was developed for the treatment of deep venous thrombosis and embolism, which are blood clot conditions in the veins and lungs. Its clinical program focused on once-weekly subcutaneous injections for these thrombotic indications. It is investigational and has not received regulatory approval for any use.
Idrabiotaparinux targets factor Xa, also known as F10, and acts as an inhibitor of this clotting enzyme. By inhibiting factor Xa, it reduces thrombin generation and blood clot formation. This mechanism underlies its investigation as an anticoagulant for deep venous thrombosis and embolism.
Idrabiotaparinux is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the drug in deep venous thrombosis and embolism. The compound is also referred to as idrabiotaparinux sodium.
Idrabiotaparinux reached Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program has been completed, and no trials are currently active. It was studied for deep venous thrombosis and embolism.
Idrabiotaparinux was evaluated in two completed Phase 3 trials. NCT00345618 assessed once-weekly idrabiotaparinux sodium injections in pulmonary embolism across 3,202 patients. NCT00311090 compared idrabiotaparinux and idraparinux in 757 patients with deep venous thrombosis of the lower limbs. Both were randomized, double-blind, and active-controlled.
Yes, idrabiotaparinux sodium is the salt form and alternative name for idrabiotaparinux. The two names refer to the same Sanofi anticoagulant candidate. Searches for either name lead to the same Phase 3 compound studied in deep venous thrombosis and embolism.