Trial Registered

Salubris completes Phase 3 add-on trial of its sacubitril/allisartan hypertension pill

The 346-patient China trial finished with a blood-pressure endpoint on the books, but no result has posted yet on a therapy already sold as a fixed-dose combination.

By AppliedXLJuly 15, 2026Trial NCT07704697

Executive Summary

A Phase 3 trial testing whether adding amlodipine to Salubris's own sacubitril/allisartan combination helps patients still above target blood pressure has completed enrollment and reached its primary completion date, with the result not yet posted.
The question is not whether the underlying neprilysin-inhibitor combination lowers blood pressure, since it is already marketed, but whether adding a calcium-channel blocker rescues patients uncontrolled on it alone.
The neprilysin-inhibitor class in hypertension is thinly populated, with only a handful of same-target trials on record, and the broader hypertension field has moved toward newer mechanisms including aldosterone-synthase inhibitors and an RNA-targeted therapy.
The trial's registry history shows a single amendment and no signs of dormancy or repeated timeline slippage, consistent with a program that ran and completed as planned rather than one that stalled.

The trial

NCT07704697 enrolled 346 adults with essential hypertension in China to test whether adding amlodipine, a calcium-channel blocker, to Salubris's sacubitril/allisartan combination lowers blood pressure further in patients who remain above target on the base regimen. The trial's registered primary endpoint is the change from baseline in mean seated systolic blood pressure after 12 weeks of randomized, double-blind treatment. Enrollment ran from November 2024 and reached its primary completion date of November 10, 2025, with the trial now marked Completed. NCT07704697

What it tests

Sacubitril/allisartan pairs a neprilysin inhibitor with an angiotensin-receptor blocker, and the trial's eligibility criteria describe a population spanning treatment-naive patients with systolic pressure of 150 to 180 mmHg and patients already on sacubitril/allisartan (240 mg once daily) who remain at 140 mmHg or above. That design targets a bridging question, add-on dosing in an already-marketed regimen, rather than a first test of whether the neprilysin-inhibitor mechanism controls blood pressure at all. NCT07704697

Competitive context

The neprilysin-inhibitor class in essential hypertension is sparsely populated: only two other trials pairing a neprilysin inhibitor with this indication have completed, both without termination, and no other trial is currently active studying Neprilysin in Essential Hypertension. The nearest direct comparators are Novartis's sacubitril combinations in Chagas disease and hypertension and Chong Kun Dang Pharmaceutical's sacubitril valsartan Phase 3 program, all sharing the same target and modality. The broader hypertension field has moved toward newer mechanisms, including AstraZeneca's aldosterone-synthase inhibitor baxdrostat and Alnylam Pharmaceuticals' RNA-targeted zilebesiran, both in Phase 3, underscoring that Salubris's trial is optimizing an established combination rather than testing a new one against that wave.

Operational read

The trial's registry history carries a single change event and a stability label of Stable, with no dormancy or repeated primary-completion-date slippage recorded. Enrollment reached its full target of 346 patients, matching the actual count against the target with no shortfall. Shenzhen Salubris Pharmaceuticals Co., Ltd. has completed all 13 of its prior trials with no terminations on record, consistent with a program that ran to plan rather than one showing signs of distress. NCT07704697

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.