MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has approved MSN Laboratories to conduct a Phase III clinical trial of Vibegron Tablets 75 mg in India. However, the approval came with the condition that patients with refractory Overactive Bladder (OAB) should be excluded from the trial.
The decision follows the company’s submission of a revised Phase III trial protocol titled “A Phase-III, Randomized, Open-Label, Active-Controlled, Multicentre Study to Evaluate the Safety and Efficacy of Vibegron 75 mg Tablet, in Comparison with Mirabegron ER 25 mg/50 mg Tablet in Patients with Overactive Bladder (OAB)” (Protocol No. 003/VIB/MSN/2024, Version 2.0, dated July 12, 2025).
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.
