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Also known as amrecibart
REGN9933 · 3 trials · 2 indications
Composite endpoint that includes: asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out
| Arm | Type | Description |
|---|---|---|
| REGN9933 | EXPERIMENTAL | Randomized 1:1:1 |
| REGN7508 | EXPERIMENTAL | Randomized 1:1:1 |
| Placebo | PLACEBO_COMPARATOR | Randomized 1:1:1 |
| Enoxaparin | ACTIVE_COMPARATOR | Enoxaparin will be administered by subcutaneous (SC) administration |
| Apixaban | ACTIVE_COMPARATOR | Apixaban will be administered orally twice a day |
| REGN9533 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| REGN9933 | DRUG | Intravenous (IV) single dose administered |
| REGN7508 | DRUG | IV single dose administered |
| Placebo | DRUG | IV single dose administered |
| Enoxaparin | DRUG | Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier) |
| Apixiban | DRUG | Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier) |
| REGN9533 | DRUG | Administered per the protocol |
| Heparin | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol 3. Body weight ≥45 kg and ≤130 kg d...
REGN9933 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN). It is being studied for the prevention of blood clots, or venous thromboembolism, and is also being evaluated in adults with end-stage kidney disease on hemodialysis. REGN9933 remains in clinical development and has not been approved by the FDA.
REGN9933 targets Factor XI, a protein involved in the blood coagulation cascade. By acting on Factor XI, the drug is designed to interfere with clot formation. Factor XI inhibition is being explored as an approach to preventing venous thromboembolism while potentially limiting effects on normal bleeding.
REGN9933 is being studied to prevent blood clots, including venous thromboembolism, in specific patient groups. Completed Phase 2 trials evaluated it for clot prevention in adults with a peripherally inserted central catheter and in adults after knee replacement surgery. It is investigational and not approved for any use.
REGN9933 is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the sponsor of the clinical trials evaluating the drug in venous thromboembolism and in end-stage kidney disease. The asset is an investigational small molecule and has not reached market approval.
REGN9933 is in Phase 1 development, with Phase 2 trials also completed in venous thromboembolism. A Phase 1 trial in adults with end-stage kidney disease on hemodialysis is currently recruiting, while two Phase 2 clot-prevention trials have been completed. The drug is investigational and has not been approved by the FDA.
REGN9933 has been evaluated in three trials. NCT07759167 is a recruiting Phase 1 study in adults with end-stage kidney disease on hemodialysis in Belgium. NCT06299111 and NCT05618808 are completed Phase 2 trials testing clot prevention in adults with a peripherally inserted central catheter and after knee replacement surgery, respectively.