Alnylam Pharmaceuticals (NASDAQ:ALNY) is advancing zilebesiran, an investigational RNA interference therapy aimed at controlling blood pressure with biannual dosing for patients with uncontrolled hypertension. The company’s Phase III ZENITH cardiovascular outcomes trial, initiated in September 2022, aims to enroll 11,000 participants across 35 countries, with a minimum follow-up of two years.
Hypertension affects nearly 1 billion individuals globally, yet only 40% are identified and treated. Phase II trials indicated that zilebesiran resulted in a placebo-adjusted systolic blood pressure reduction of 10 mmHg, allowing participants continuous control for up to a year. Alnylam anticipates a 15% to 20% reduction in major adverse cardiovascular events based on observed blood pressure reductions as it proceeds with the ZENITH trial.
The trial’s primary outcomes focus on crucial cardiovascular events, including death, myocardial infarction, and hospitalization for heart failure. ZENITH has received Fast Track designation from the FDA, and Alnylam is concurrently planning potential development opportunities in heart failure and chronic kidney disease should the results prove successful.
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