Nocturia (defined as waking frequently to urinate at night, thereby disturbing sleep considerably) is a common condition, and its prevalence increases markedly with age. It is often the presenting symptom in men with benign prostatic hypertrophy and affects at least 70% of benign prostatic hypertrophy patients.

Although some symptoms of benign prostatic hypertrophy are successfully addressed by the standard benign prostatic hypertrophy therapies of alpha blockers and 5-alpha reductase inhibitors, nocturia remains inadequately treated. Estimates put the number of benign prostatic hypertrophy/nocturia sufferers at 55 million in the seven largest markets worldwide; only 10% of these are believed to be receiving any kind of treatment, making it a clear area of unmet medical need.

VA106483 is a novel small-molecule drug candidate that exerts its effect as an anti-diuretic directly in the kidney by binding to vasopressin (V2) receptors, which regulate water balance.

The double-blind, placebo-controlled, dose-response Phase IIa study was designed to investigate the pharmacodynamics and pharmacokinetics of single and repeated oral doses of VA106483. The trial involved 27 elderly men aged 65 years or more with a history of nocturia. Based on these results, Vantia now plans to advance VA106483 into a larger Phase IIb clinical efficacy study in the second half of 2009.