Therapeutic efficacy of Vibegron

Vibegron’s exposure-response relationship and the time course of pharmacodynamic response are not fully  characterized.  

In a 4-week, randomized, placebo-controlled, ambulatory blood pressure study in OAB patients (n=200), daily  treatment with Vibegron 75 mg was not associated with clinically significant changes in blood pressure.  Subjects enrolled in this study had a mean age of 59 years and 75% were female. Thirty-five percent of subjects  had pre-existing hypertension at baseline and 29% of all subjects were taking at least 1 concomitant  antihypertensive medication.  

Cardiac Electrophysiology  Vibegron does not prolong the QT interval to any clinically relevant extent at a single dose 5.3 times the  approved recommended dose.

from FDA,2020.12