MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients

Vibegron is a beta-3 adrenergic agonist for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

Vibegron is a potent, selective beta-3 adrenergic receptor (β3) agonist that relaxes the detrusor smooth muscle of the bladder, thereby increasing bladder capacity. Vibegron was first approved in Japan in September 2018 for the treatment of overactive bladder, a condition associated with distressing symptoms of urge urinary incontinence, urgency, and urinary frequency, and reduced quality of life of patients. On December 23, 2020, vibegron was approved for the same indication in adults.

After detailed deliberation, the committee recommended for grant of permission to conduct a Phase III clinical trial as per the revised protocol presented by the firm, with the condition that patients with refractory OAB should be excluded from the trial.