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Zilebesiran · 3 trials · 4 indications
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Zilebesiran 300 mg | EXPERIMENTAL | Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications. |
| Zilebesiran | EXPERIMENTAL | Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period. |
| Name | Type | Description |
|---|---|---|
| Zilebesiran | DRUG | Zilebesiran will be administered SC |
| Placebo | DRUG | Placebo will be administered SC |
Inclusion Criteria: * Is 18 years or older for patients with established cardiovascular disease (CVD) * Is 55 years or older for patients with high risk for CVD * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD * Has treated hypertension...
Zilebesiran is an investigational small molecule being developed for cardiovascular conditions, specifically for high risk cardiovascular disease, high cardiovascular risk, and mild to moderate hypertension. It is being studied as an add-on therapy in patients whose hypertension is not adequately controlled by standard of care antihypertensive medications.
Zilebesiran is a small molecule that belongs to the -siran (siRNA) target class. It is designed to interfere with gene expression at the RNA level, though the specific molecular target is not disclosed in the available information.
Zilebesiran is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALNY.
Zilebesiran is in Phase 3 clinical development. A Phase 3 trial (NCT07181109) is currently recruiting patients with hypertension not adequately controlled and with either established cardiovascular disease or high risk for cardiovascular disease. It is not FDA approved and remains investigational.
Zilebesiran has been studied in several trials. A Phase 2 trial (NCT06272487) evaluated it as add-on therapy in high cardiovascular risk patients with hypertension. A Phase 1 trial (NCT06423352) studied it in Japanese patients with mild to moderate hypertension. A Phase 3 trial (NCT07181109) is currently recruiting.
No, Zilebesiran is the drug being studied, while KARDIA-3 is the name of a clinical trial (NCT06272487) that evaluated Zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications.