Altasciences Performs Phase I Studies for FDA Approval of Vibegron

Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing three early phase clinical trials. Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. The approval was announced by Urovant Sciences on December 23, 2020.

“We take tremendous pride in contributing to the FDA approval of much-needed medicines that improve the health and wellbeing of patients,” said Amy Denvir, General Manager at Altasciences’ Kansas clinical pharmacology unit. “Working with Urovant Sciences on this program has been a pleasure, and we are delighted to see it come to fruition.”

Altasciences’ expert clinical teams provided clinical support for two drug-drug interaction studies and a bioavailability trial, conducted in 2018 and 2019, in healthy subjects. These trials were supported by Altasciences’ data services team, who performed the full data management and reporting for the associated clinical studies.