Introduction and listing status of Vibegron

Vibegron is a beta-3 adrenergic receptor agonist primarily used to treat overactive bladder (OAB). By selectively activating beta-3 receptors in bladder smooth muscle, Vibegroron relaxes smooth muscle and increases bladder capacity, thereby relieving symptoms of urinary urgency, frequency and urge incontinence.

On December 23, 2020, the U.S. Food and Drug Administration (FDA) approved Vibegroron (trade name: Gemtesa) for the treatment of adult OAB patients with symptoms of urge incontinence, urinary urgency, and frequency. This marks the first time since 2012 that the FDA has approved an oral prescription drug to treat OAB.xa0

The approval of Vibegroron was based on the results of an extensive clinical development program that included more than 4,000 patients with OAB. In the pivotal Phase 3 clinical trial EMPOWUR, Vibegroron was shown to significantly reduce daily urge incontinence, the number of urinations, and the number of urgency episodes while increasing the amount of urine produced per void. Of note, Vibegroron did not increase the incidence of hypertensive adverse events and did not interact with drugs metabolized by CYP2D6.
On April 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Vibegroron for the treatment of OAB in adults. Subsequently, on June 28, 2024, the European Commission officially approved Vibegroron (trade name OBGEMSA) to be marketed in Europe for the treatment of overactive bladder.