SEC Recommends Phase III Trial of MSN Labs' Vibegron Against Mirabegron in Overactive Bladder

The approval follows the firm’s submission of a revised clinical trial protocol, made in light of an earlier SEC recommendation dated 17 April 2025. The updated Phase III design is 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” (Protocol No. 003/VIB/MSN/2024, Version 2.0, dated 12 July 2025).

During the meeting held on 18 September 2025 at CDSCO headquarters, the committee deliberated in detail on the revised proposal. After careful review, the SEC recommended that the Phase III clinical trial may be conducted as per the revised protocol presented by the firm. However, it placed a condition that patients with refractory overactive bladder should not be included in the trial population.

Vibegron is a selective β3-adrenergic receptor agonist that works by relaxing the detrusor smooth muscle of the bladder, thereby increasing bladder capacity. It is being developed to treat patients with OAB presenting with symptoms of urge urinary incontinence, urgency, and increased urinary frequency. The comparator drug in this trial, Mirabegron, is already marketed in India and globally for OAB, making it a standard reference for efficacy and safety comparison.

The Phase III trial, designed as an open label, randomized, multicentre, active-controlled study, will evaluate Vibegron against Mirabegron ER in OAB patients to generate robust data for potential regulatory submission. Excluding refractory patients ensures a more focused assessment of treatment outcomes in the target population.

Also Read: CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine