- In May 2024, Sumitomo Pharma America announced that the U.S. FDA accepted a supplemental New Drug Application (sNDA) for vibegron (GEMTESA), a beta-3 adrenergic agonist. If approved, vibegron will become the first and only beta-3 agonist indicated for treating men with OAB symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH)
- In February 2024, Avation Medical launched the Vivally System, the first FDA-cleared, non-invasive, wearable neuromodulation device designed for home use. This system delivers autonomously adjusted electrical stimulation to treat urge urinary incontinence and urinary urgency caused by OAB syndrome, offering a convenient and effective alternative to traditional treatments
- In December 2024, the U.S. Food and Drug Administration (FDA) approved Gemtesa (vibegron) for the treatment of overactive bladder (OAB) symptoms—such as urge urinary incontinence, urgency, and urinary frequency—in adult males undergoing pharmacological therapy for benign prostatic hyperplasia (BPH). This makes vibegron the first and only beta-3 adrenergic agonist approved for this specific patient population
- In March 2021, Myrbetriq received the U.S. Food and Drug Administration approval to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older
- In December 2020, FDA approved GEMTESA (Vibegron) for the treatment of adults with overactive bladder (OAB). Vibegron is a small molecule, selective human beta-3 adrenergic agonist developed by Urovant Sciences, a subsidiary of Sumitovant Biopharma
