Roche and Alnylam advance zilebesiran into global phase III cardiovascular outcomes trial for people with uncontrolled hypertension
(RO) Basel, 30 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam (Nasdaq: ALNY) today announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ability of zilebesiran, a RNAi therapeutic, to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension. This decision was informed by the comprehensive KARDIA Phase II programme, including KARDIA 1, KARDIA 2 and the most recent KARDIA-3 study evaluating the efficacy and safety of zilebesiran in patients with uncontrolled hypertension and high cardiovascular (CV) risk, on two to four standard of care antihypertensives. In particular, KARDIA-3 aimed to define the patient population to be investigated in the Phase III CV outcomes trial.
Related Questions
What is the anticipated timeline, enrollment size, and potential market impact of the Phase III CVOT for zilebesiran on Roche and Alnylam’s valuations?
How does zilebesiran’s efficacy, safety, and RNAi mechanism compare to existing hypertension treatments and competing pipeline candidates from other pharma companies?
What are the regulatory, reimbursement, and revenue forecast implications if the trial demonstrates a significant reduction in major adverse cardiovascular events?