vibegron (Gemtesa): FDA status
Approved Approved Jan 3, 2025. Indication: Overactive bladder symptoms in men receiving pharmacologic therapy for BPH. Company: Sumitomo Pharma America.
Regulatory history
- Jan 3, 2025: Approved. FDA approved Gemtesa for overactive bladder in men with benign prostatic hyperplasia. Medical Xpress
- Dec 18, 2024: Label expanded. FDA approved Gemtesa as first and only beta3 adrenergic receptor agonist for men with OAB symptoms receiving BPH pharmacologic therapy, based on COURAGE trial. proudp.com
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