Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN9933 · 5 trials · 3 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 | - |
| Arm 1: Aspirin | ACTIVE_COMPARATOR | Randomized 1:1:1:1 |
| Arm 2: Aspirin + REGN9933 | EXPERIMENTAL | Randomized 1:1:1:1 |
| Arm 3: Aspirin + REGN7508 | EXPERIMENTAL | Randomized 1:1:1:1 |
| Arm 4: Aspirin + Rivaroxaban | ACTIVE_COMPARATOR | Randomized 1:1:1:1 |
| Intravenous Cohorts | EXPERIMENTAL | Randomized 6:2 to REGN9933 or placebo |
| Subcutaneous Cohorts | EXPERIMENTAL | Randomized 6:2 to REGN9933 or placebo |
| 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 |
| Aspirin | DRUG | Oral administration |
| Rivaroxaban | DRUG | Oral administration |
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 being studied for preventing blood clots, including venous thromboembolism after knee replacement surgery and in adults with a peripherally inserted central catheter. It is also being evaluated in healthy volunteers and in adults with end-stage kidney disease on hemodialysis.
REGN9933 targets Factor XI, a protein involved in blood clotting. By targeting Factor XI, REGN9933 is being studied as a potential anticoagulant to prevent blood clots while possibly reducing bleeding risk compared to other anticoagulants.
REGN9933 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker REGN.
REGN9933 is in Phase 1 clinical development. It has completed Phase 1 and Phase 2 trials, and a new Phase 1 trial in end-stage kidney disease is planned but not yet recruiting. It is not approved by the FDA and remains investigational.
REGN9933 has been studied in several trials. NCT05102136 was a Phase 1 healthy volunteer study. NCT05618808 was a Phase 2 trial for preventing blood clots after knee replacement. NCT06299111 was a Phase 2 trial for preventing clots with a PICC line. NCT07759167 is a planned Phase 1 trial in end-stage kidney disease.
No, REGN9933 is a distinct investigational drug from REGN7508 and REGN9533. These are separate monoclonal antibodies being studied by Regeneron, sometimes in the same trials, such as NCT06299111 and NCT07759167, but they are not the same compound.