Roche ：Zilebesiranhas been granted Breakthrough Therapy designation.
On June 2, the CDE official website showed that Zilebesiran Injection, a Category 1 new drug, is proposed to be granted Breakthrough Therapy designation for the treatment of adult patients with hypertension who have established cardiovascular disease or are at high risk for cardiovascular disease, to reduce the risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and heart failure events (heart failure hospitalization or urgent visits).
Zilebesiran is a subcutaneously administered RNA interference therapy developed by Alnylam that inhibits the synthesis of AGT in the liver, leading to a durable reduction in AGT protein levels and ultimately lowering levels of the vasoconstrictor angiotensin II (Ang II). In July 2023, Roche entered into a collaboration with Alnylam for this drug, with a total transaction value of up to US$2.8 billion. In September 2025, the two companies officially initiated ZENITH, a global Phase III cardiovascular outcomes trial of Zilebesiran in patients with uncontrolled hypertension, planning to enroll approximately 11,000 patients to evaluate the cardiovascular benefit of once every six month dosing compared with placebo.
The initiation of this Phase III trial is based on the comprehensive KARDIA Phase II program, including KARDIA 1, KARDIA 2, and the latest KARDIA 3 study. The KARDIA 3 study was designed to evaluate the efficacy and safety of Zilebesiran in patients with uncontrolled hypertension and high cardiovascular risk who were receiving two to four standard antihypertensive medications. In particular, the KARDIA 3 study aimed to define the patient population for the Phase III cardiovascular outcomes trial. Results from the KARDIA 3 study showed that a single subcutaneous dose of Zilebesiran (300 mg, once every six months) achieved a significant reduction in office systolic blood pressure (SBP) at the primary endpoint at Month 3 (-5.0 mmHg; p=0.0431), with durability of effect through Month 6 (-3.9 mmHg; 95% CI: [-8.5, 0.7]). The study met its objective of identifying the patient population most likely to benefit from Zilebesiran, and also showed an encouraging safety profile and clinically meaningful placebo adjusted blood pressure reductions.
As observed in the KARDIA 2 Phase II study, the KARDIA 3 results support the significant benefit of Zilebesiran when used in combination with common diuretics. In an analysis of patients on diuretics with baseline blood pressure >140 mmHg, placebo adjusted blood pressure reductions were 9.2 mmHg at Month 3 and 8.3 mmHg at Month 6. Both the literature and clinical practice have confirmed that such combination therapy enhances the blood pressure lowering effect. It is worth noting that Roche has high expectations for this drug, anticipating a filing around 2028 and forecasting peak sales of over CHF 3 billion.
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