Relaxera has received US FDA clearance for its Investigational New Drug application covering relaxin-2 in heart failure with preserved ejection fraction and atrial fibrillation, opening the way for Phase II clinical work in the US.
The Germany-based company is developing relaxin-2, a synthetic form of the human peptide hormone, as a therapy for chronic cardiovascular disease. Alongside the FDA clearance, Relaxera said it plans to begin a European Phase II study in the first half of 2026, with a targeted enrolment of 320 to 350 patients in a randomised, double-blind, placebo-controlled, multi-centre trial.
Thomas Bernd Dschietzig, chief executive of Relaxera, called the FDA decision “a defining moment for Relaxera and for the broader chronic heart failure field”, arguing that the programme is aimed at a patient population still marked by high unmet need. That claim lands in a field that has moved on in the past year, but HFpEF remains one of the more difficult cardiovascular syndromes to treat consistently because it combines diastolic dysfunction, fibrosis, inflammation, renal involvement, and a heavy burden of metabolic disease.
Relaxera’s pitch is that relaxin-2 can address several of those mechanisms at once. The company says the candidate acts through RXFP1, the glucocorticoid receptor, and Wnt1-related pathways, with intended effects spanning vasodilation, anti-fibrotic activity, anti-inflammatory action, and anti-arrhythmic support. The scientific case will now have to stand up in a mid-stage clinical setting where endpoints, patient stratification, and biomarker selection are likely to matter as much as the headline mechanism.
The regulatory milestone also feeds directly into business development. Relaxera said it has started a formal partnering process covering co-development, licensing, and broader strategic collaboration for HFpEF and potentially other cardiovascular indications. With the European Phase II programme being prepared in parallel, the company is trying to turn a regulatory clearance into a sharper commercial proposition.
Companies interested in partnering opportunities can contact Relaxera directly.
