OMACOR^® is the focus of an extensive and ambitious clinical development program that seeks to build on the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione study. Studies currently in progress include very large clinical outcome trials designed to evaluate the impact of OMACOR^® on death and major morbid events in defined patient populations such as individuals with heart failure or diabetes, specialist investigations in very high-risk populations such as patients requiring hemodialysis, and a range of specialized studies concerned with mechanisms of action and effects on biochemical and laboratory indices. The emergence of results from these studies can be expected to define a spectrum of indications for OMACOR^® in the management of cardiovascular and renal disease.