Hypertension is a major global risk factor for cardiovascular diseases, and antihypertensive drugs are chemical or biological agents used for the prevention and treatment of hypertension and related cardiovascular diseases. In recent years, with the intensifying aging of the population and the escalating demand for chronic disease management, the market for antihypertensive drugs has been continuously expanding, and global hypertension treatment is also accelerating from "broad-spectrum blood pressure lowering" towards "precision targeting". It is reported that since 2026, various new mechanism drugs have achieved breakthroughs.
On June 2nd, the China Food and Drug Administration (CDE) announced that Alnylam's innovative drug, Zilebesiran injection, is proposed to be included as a breakthrough therapy for adult patients with hypertension who have cardiovascular diseases or are at high risk of cardiovascular diseases, aiming to reduce the risks of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and heart failure events (hospitalization or emergency visits due to heart failure).
It is understood that Zilebesiran, jointly developed by Alnylam and Roche, is an siRNA therapy targeting angiotensinogen (AGT). This drug breaks through the traditional antihypertensive treatment paradigm, achieving sustained blood pressure control for up to six months with a single subcutaneous injection, changing the routine daily medication regimen for patients with hypertension and addressing the long-term medication adherence challenge from its root.
On May 18th, the US Food and Drug Administration (FDA) officially announced the approval of Baxdrostat (brand name Baxfendy), developed by AstraZeneca, for marketing. It is intended for use in combination with other antihypertensive medications in adult patients with poorly controlled hypertension.
The core support for Baxdrostat's FDA approval this time comes from the data from the BaxHTN Phase III clinical trial. The results showed that at the 12th week of treatment, the average sitting systolic blood pressure in the Baxdrostat 2mg dose group decreased by 15.7 mmHg compared to baseline, and the decrease was still 9.8 mmHg after placebo adjustment. The absolute decrease in the 1mg dose group was 14.5 mmHg, and the decrease after adjustment was 8.7 mmHg.
In addition, the US company Mineralys Therapeutics has developed Lorundrostat, and its New Drug Application (NDA) has been accepted by the Food and Drug Administration (FDA). The target review date for the Pre-Drug User Fee Act (PDUFA) has been set for December 22, 2026. Lorundrostat is an oral, highly selective aldosterone synthase (ALDOS) inhibitor, primarily targeted for third- and fourth-line treatment of patients with hypertension, specifically those with uncontrolled, drug-resistant, and refractory hypertension.
Additionally, Boehringer Ingelheim's compound BI 690517, a highly selective aldosterone synthase inhibitor (ASi), has also entered the late-stage clinical development phase. It is designed to treat cardiorenal metabolic diseases, particularly chronic kidney disease (CKD) and heart failure (HF), by inhibiting the excessive production of aldosterone. It is worth mentioning that BI 690517 is not solely developed as an antihypertensive drug. Its uniqueness lies in its positioning as a "cardiorenal protectant".
Overall, from ASI to siRNA, and from "daily medication" to "semi-annual injections", it is evident that the treatment of hypertension is accelerating towards a new era of "precision, long-lasting efficacy, and simultaneous protection of heart and kidneys". In the future, the core competition in the antihypertensive drug market will be a comprehensive contest of technological barriers, clinical value, and patient compliance. Meanwhile, the next generation of drugs based on new mechanisms, targets, and delivery technologies is expected to shape the market landscape in the next decade.