The current Food and Drug Administration (FDA) draft guidance for renal impairment studies advises performance of a PK study in patients with renal impairment for medications primarily excreted in urine and also for medications primarily metabolized or secreted in bile. The major routes of excretion of bevenopran in animals were identified as hepatobiliary and renal. In addition, preliminary findings show >40% of an oral bevenopran dose is eliminated unchanged in urine over a 48-72 hour period post-dose.