Idorsia Achieves Sustained Albuminuria Reductions with Aprocitentan in Phase 3 PRECISION Renal Analysis

Post-approval renal endpoint data from Idorsia's Phase 3 PRECISION study positions aprocitentan as a candidate for label expansion discussions, with new analyses showing clinically meaningful, sustained reductions in albuminuria across a resistant hypertension population already on maximal antihypertensive therapy. The findings were presented by Prof. Markus Schlaich at the 35th Congress of the European Society of Hypertension (ESH) on 1 June 2026.

The analysis evaluated 730 patients with confirmed resistant hypertension receiving at least three antihypertensive agents, including a diuretic. Aprocitentan, a dual endothelin receptor antagonist, produced rapid reductions in urine albumin-creatinine ratio (UACR) by Week 4, with effects sustained through Week 36. In patients with baseline microalbuminuria, mean UACR fell from 77.5 mg/g to 34 mg/g; in those with macroalbuminuria, from 860.2 mg/g to 286.7 mg/g. Placebo arms showed minimal change across both strata.

For regulatory affairs leads tracking sNDA or label expansion strategy for cardiovascular agents, the UACR data carry specific weight. Albuminuria is a recognised surrogate endpoint in renal outcomes trials and a biomarker embedded in ICH E9(R1) estimand frameworks; its sustained reduction in a resistant hypertension cohort strengthens the evidentiary package beyond primary blood pressure endpoints. Up to 45% of patients with microalbuminuria achieved normal albumin levels as early as Week 4, a shift in risk category that regulators and payers increasingly treat as a clinically meaningful outcome distinct from blood pressure control alone.

The clinical relevance for QA and medical affairs teams also extends to the comorbidity profile of this population. Resistant hypertension frequently co-presents with chronic kidney disease and type 2 diabetes, complicating treatment decisions where hyperkalemia risk limits renin-angiotensin-aldosterone system agent titration. Aprocitentan's endothelin pathway mechanism operates independently of that axis, a pharmacological distinction that may inform prescribing guidance language in any supplemental submission.

The data were simultaneously supported by a publication in Hypertension examining aprocitentan in patients with chronic kidney disease and resistant hypertension, providing a peer-reviewed anchor for any regulatory dossier referencing these endpoints.

The degree to which these renal biomarker findings translate into a formal sNDA filing or label update will depend on Idorsia's regulatory strategy and the agency's position on UACR as a primary versus supportive endpoint in the cardiovascular indication context.

Source: Idorsia Ltd via GlobeNewswire, 1 June 2026; data presented at the 35th ESH Congress by Prof. Markus Schlaich, University of Western Australia.