Novo Nordisk POSEIDON Study Finds CV Inflammation in 2 in 5 High-Risk Patients Globally

Novo Nordisk's 18,904-patient POSEIDON real-world evidence study, presented at the 94th European Atherosclerosis Society Congress in Athens, quantifies a treatment gap that QA and regulatory teams at cardiovascular drug manufacturers should be tracking closely: 40% of patients with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease, and an equivalent proportion with heart failure, carry measurable cardiovascular inflammation despite guideline-recommended standard-of-care therapy.

CV inflammation was defined in POSEIDON by high-sensitivity C-reactive protein (hsCRP) levels ≥2 mg/L, the most widely available blood-based inflammatory marker in clinical practice. The study enrolled patients across 18 countries spanning Europe, North America, South America, and Asia-Pacific between 2023 and 2025, making it one of the largest contemporary global assessments of CV inflammation prevalence in this population. A parallel analysis published in the European Journal of Heart Failure confirmed the same two-in-five prevalence rate specifically within the heart failure cohort.

The clinical significance is well-established in the literature: CV inflammation is an independent risk factor for major adverse cardiovascular events, including myocardial infarction, stroke, and CV death. Inflammation also accelerates CKD progression, and CKD in turn amplifies inflammatory burden, a feedback cycle that compounds residual CV risk even when lipid, blood pressure, and glycaemic targets are met. Novo Nordisk's chief medical officer, Filip Knop, described the findings as evidence supporting the company's ongoing development of a first-in-class anti-inflammatory cardiovascular therapy targeting this unmet need.

For drug development and manufacturing operations, the POSEIDON data carry forward-looking implications. A novel anti-inflammatory CV agent entering late-stage development would face a regulatory pathway requiring robust biomarker-driven patient stratification, likely centred on hsCRP thresholds, which has direct consequences for clinical trial design, companion diagnostic considerations, and ultimately labelling strategy under ICH E16 and related biomarker guidance. Formulation and process development teams should also note that anti-inflammatory mechanisms in cardiovascular indications have historically involved biologics or small molecules with demanding sterility assurance and cold-chain requirements, adding complexity to technology transfer and 21 CFR Part 211 compliance planning at commercial scale.

Professor Carolyn Lam of the National Heart Centre Singapore, a POSEIDON investigator, noted the consistency of inflammatory signals across diverse patient populations as a practical signal for patient identification strategies, a point that will shape inclusion criteria and endpoint selection in any pivotal programme that follows.

The consistency of the hsCRP ≥2 mg/L threshold across geographies and heart failure subtypes gives Novo Nordisk a defined patient-selection anchor as it advances its anti-inflammatory CV programme toward what would be a first regulatory submission in this category.

Source: Novo Nordisk via GlobeNewswire, 26 May 2026.