Novartis's Anti-Inflammatory Drug Pacibekitug Shows Sustained Effect Through Six Months in Trial

A Novartis drug newly acquired by the company, pacibekitug, produced sustained reductions in inflammation-related biomarkers through six months in patients with chronic kidney disease and elevated inflammatory risk linked to heart disease, according to final results from the Phase 2 TRANQUILITY trial. The results were presented Aug. 29 in a Hot Line Session at the European Society of Cardiology Congress (ESC 2026) in Munich, Germany, by Dr. Deepak L. Bhatt, director of Mount Sinai Fuster Heart Hospital.

Pacibekitug is an investigational, long-acting monoclonal antibody — a lab-made protein designed to target a specific molecule — that targets interleukin-6 (IL-6), a signaling protein involved in inflammatory pathways that has been associated with cardiovascular risk. The randomized, double-blind, placebo-controlled trial enrolled 143 adults with chronic kidney disease and elevated high-sensitivity C-reactive protein (hsCRP), a marker of inflammation, who were randomized to placebo or one of three pacibekitug dosing regimens and followed for 180 days.

On day 180, time-averaged hsCRP reductions ranged from 76% to 89% across the pacibekitug treatment groups, compared with a 7% increase in the placebo group. Investigators also reported a dose-dependent drop in biomarker levels, meaning higher doses led to greater reductions. Pacibekitug was generally well tolerated, and no new safety signals were identified, extending earlier results that had shown substantial biomarker reductions through 90 days.

'These findings demonstrate that durable suppression of the IL-6 pathway is achievable with infrequent dosing of a long-acting monoclonal antibody,' Bhatt said. 'The next critical step is to determine whether the effects observed in TRANQUILITY translate into improved cardiovascular outcomes in patients with elevated inflammatory cardiovascular risk,' he said, adding that the findings support continued evaluation of IL-6 inhibition in larger studies.