Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MAA868
Abelacimab · 2 trials · 1 indication
Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
All suspected bleeding events either reported by the patient or observed by the Investigator
Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
| Arm | Type | Description |
|---|---|---|
| Abelacimab (MAA868) | EXPERIMENTAL | abelacimab 150 mg subcutaneous (SC) |
| Placebo | PLACEBO_COMPARATOR | Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly. |
| Name | Type | Description |
|---|---|---|
| Abelacimab | BIOLOGICAL | Abelacimab provided as liquid in vial (150 mg/mL) |
| Placebo | DRUG | Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab |
Inclusion Criteria: * Patients are able to provide written informed consent to enter the extension part. * Patients must be on study treatment at the time of EoT visit in the core part. Exclusion Criteria: * Patients meeting any exclusion criteria in the core part. * Patients who have a history o...
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 |
Abelacimab is an investigational monoclonal antibody being developed for patients with Atrial Fibrillation (AF) who are at high risk and have been deemed unsuitable for oral anticoagulation. It is currently in Phase 3 clinical development, with trials evaluating its efficacy and safety in this patient population.
Abelacimab targets and inhibits Factor XI (F11), a protein involved in blood clotting. By inhibiting this target, Abelacimab is designed to potentially reduce thrombotic events in patients with Atrial Fibrillation who cannot take oral anticoagulants. It is a monoclonal antibody with an inhibitor mechanism of action.
Abelacimab is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with Atrial Fibrillation.
Abelacimab is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials are ongoing or planned to assess its efficacy and safety in high-risk patients with Atrial Fibrillation who are unsuitable for oral anticoagulation.
Abelacimab is being studied in two Phase 3 clinical trials. The first, NCT05712200 (LILAC-TIMI 76), is recruiting 1,900 participants across multiple countries. The second, NCT07739888, is not yet recruiting and plans to enroll 2,500 participants. Both trials focus on high-risk patients with Atrial Fibrillation unsuitable for oral anticoagulation.
No, Abelacimab is the drug being studied, while LILAC-TIMI 76 is the name of one of its clinical trials. The trial, identified as NCT05712200, is a Phase 3 study evaluating the efficacy and safety of Abelacimab in high-risk patients with Atrial Fibrillation who have been deemed unsuitable for oral anticoagulation.