What is the indication for Gemtesa (vibegron)?

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Last updated: February 11, 2025 • View editorial policy

From the FDA Drug Label

GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. (1.1) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). (1.2)

The indication for Gemtesa (vibegron) is for the treatment of overactive bladder (OAB) with symptoms of:

  • Urge urinary incontinence
  • Urgency
  • Urinary frequency in adults, including those with benign prostatic hyperplasia (BPH) who are on pharmacological therapy 1.

From the Research

Indication for Gemtesa (Vibegron)

The indication for Gemtesa (vibegron) is for the treatment of overactive bladder (OAB) symptoms, including:

  • Urinary frequency
  • Urgency
  • Urgency incontinence

Clinical Trials and Studies

Studies have shown that vibegron is effective in improving OAB symptoms, with significant improvements in:

  • Mean number of micturitions per day 2, 3, 4, 5
  • Mean number of urgency episodes per day 2, 3, 4, 5
  • Mean number of urgency incontinence episodes per day 2, 3, 4, 5
  • Quality of life (QoL) 4, 5

Safety and Tolerability

Vibegron has been shown to be well-tolerated, with a favorable safety profile, and a low incidence of adverse events, including:

  • Dry mouth 3, 4, 5
  • Hypertension 4
  • Urinary tract infection 4
  • Headache 4
  • Nasopharyngitis 4

Approval and Availability

Vibegron was approved by the US Food and Drug Administration (FDA) for the treatment of OAB symptoms 2, and has also been approved in Japan for the same indication 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.