Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Abelacimab is an investigational monoclonal antibody being studied for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) who are considered high-risk and unsuitable for oral anticoagulation. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Abelacimab is a monoclonal antibody that targets factor XI, a protein involved in blood clotting. By inhibiting factor XI, it aims to reduce thrombus formation without increasing bleeding risk, which is particularly relevant for atrial fibrillation patients who cannot take standard oral anticoagulants.
Abelacimab is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in high-risk atrial fibrillation patients.
Abelacimab is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Two Phase 3 trials are ongoing or planned to assess its safety and efficacy in patients with atrial fibrillation who are unsuitable for oral anticoagulation.
Abelacimab is being evaluated in two Phase 3 trials. The first, NCT05712200 (LILAC-TIMI 76), is recruiting 1,900 patients with atrial fibrillation who are unsuitable for oral anticoagulation. The second, NCT07739888, is planned to enroll 2,500 patients in a similar population. Both are randomized, double-blind, placebo-controlled studies.
Abelacimab is a distinct investigational monoclonal antibody and is not known by any other names. It is being developed specifically for atrial fibrillation patients at high risk of stroke who cannot use oral anticoagulants. No alternative names or brand names have been reported for this drug.