Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN7508 (IV), cenvacibart
REGN7508 · 11 trials · 7 indications
Part 1
Part 1
Part 2
Part 2
Cohort 1
Cohort 1 and 2
Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding
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 |
|---|---|---|
| Cenvacibart | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| REGN7508 | EXPERIMENTAL | - |
| REGN9933 | EXPERIMENTAL | - |
| Apixaban | ACTIVE_COMPARATOR | - |
| REGN7508 + Placebo | EXPERIMENTAL | - |
| Apixaban + Placebo | ACTIVE_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| REGN7508 and Placebo | EXPERIMENTAL | - |
| Placebo and ASA | ACTIVE_COMPARATOR | - |
| IV REGN7508 | EXPERIMENTAL | - |
| IV Placebo, SC REGN7508 | EXPERIMENTAL | - |
| IV Placebo, apixaban | ACTIVE_COMPARATOR | - |
| IV Placebo, enoxaparin | ACTIVE_COMPARATOR | - |
| Enoxaparin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cenvacibart | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
| REGN7508 | DRUG | Administered per the protocol |
| REGN9933 | DRUG | Administered per the protocol |
| Apixaban | DRUG | Administered per the protocol |
| Rivaroxaban | DRUG | Administered per the protocol |
| Acetylsalicylic Acid (ASA) | DRUG | Administered per the protocol |
| Enoxaparin | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Has a recent onset of neurological deficit attributed to non-cardioembolic focal brain ischemia as described in the protocol 2. Has index event (non-cardioembolic, non-procedural ischemic stroke, or high-risk TIA) within 30 days prior to randomization as described in the ...
Top 5 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | REGN7508, REGN9933 |
| Johnson & Johnson | JNJ | 14 | PHASE3 | Milvexian |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Abelacimab, PKN605 |
| Milestone Pharmaceuticals, Inc. | MIST | 1 | PHASE3 | Etripamil |
| Bayer | BAYRY | 1 | PHASE2 | BAY 3670549 |
REGN7508 is an investigational small molecule developed by Regeneron Pharmaceuticals that targets Factor XI, a protein involved in the blood clotting cascade. It is being studied as an anticoagulant for conditions including atrial fibrillation, venous thromboembolism, cancer-associated thrombosis, and peripheral artery disease.
REGN7508 is being developed to prevent and treat thrombotic conditions. Its Phase 3 program covers stroke and systemic embolism prevention in atrial fibrillation, treatment and secondary prevention of venous thromboembolism in cancer patients, VTE prophylaxis in patients with a peripherally inserted central catheter, and peripheral artery disease.
REGN7508 targets Factor XI, a protein in the coagulation pathway. Inhibiting Factor XI is being explored as an approach to reduce clot formation while potentially preserving hemostasis. REGN7508 is a small molecule directed at this protein target.
REGN7508 is being developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is running the Phase 3 clinical program for the asset across several cardiovascular and thrombotic indications.
REGN7508 is in Phase 3 clinical development. It is investigational and has not been established as approved therapy. Four Phase 3 trials are listed for the program, three of which are currently recruiting, with total planned enrollment of about 19,192 participants across the studies.
REGN7508 is in four Phase 3 trials: NCT07626411 in atrial fibrillation, NCT07430956 in atrial fibrillation for patients unsuitable for oral anticoagulation, NCT07493304 in cancer-associated venous thromboembolism, and NCT07697599 for VTE prophylaxis with a peripherally inserted central catheter. All are randomized, double-blind, and active-controlled.