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Can men take Gemtesa?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on March 30, 2025.

Official answer

by Drugs.com

Yes, men can take Gemtesa (vibegron) for the treatment of overactive bladder (OAB). Overactive bladder is a condition that causes urinary urgency, frequency, and incontinence.

Gemtesa is a once-daily tablet that can be taken with or without food. It is FDA approved to treat:

  • Adults with overactive bladder
  • Men with overactive bladder and benign prostatic hyperplasia (BPH)

Effectiveness in Men

Early clinical trials primarily included women (85% of participants). Researchers did not find a significant difference in Gemtesa’s effectiveness between genders. After 12 weeks, participants taking Gemtesa experienced fewer OAB symptoms compared to those on a placebo.

More recently, a clinical study (COURAGE trial) of Gemtesa included 1,105 men with overactive bladder symptoms receiving treatment for benign prostatic hyperplasia. Compared to placebo, patients taking Gemtesa saw a significant improvement in OAB symptoms.

This is not all the information you need to know about Gemtesa (vibegron) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

Gemtesa [package insert]. Revised Feb 2024. Sumitomo Pharma America, Inc. Accessed 05/31/2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25f21d25-14f8-4fda-91f6-7aa8b68aa1c8

Staskin, D., et. al. (2024). Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial. In: The Journal of Urology. Accessed 05/31/2024 at https://pubmed.ncbi.nlm.nih.gov/38708869/

United States Food and Drug Administration. (2021). Drug Trials Snapshot: GEMTESA. Accessed 05/31/2024 at https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-gemtesa

Read next

Can Gemtesa cause dementia?

Cognitive decline, which may include dementia, memory loss and confusion, is not a known side effect for Gemtesa (vibegron) or the beta-3 agonist class as a whole. In addition, a study found the use of anticholinergic medications among patients with overactive bladder (OAB) was associated with an increased risk of new-onset dementia compared to beta-3 agonist users. Continue reading

How long does it take for Gemtesa (vibegron) to work?

Gemtesa (vibegron) starts working almost immediately – within a few days of first taking it, with noticeable improvements in urinary urgency, frequency, and incontinence noted in clinical trials at 2 weeks which were reported as significant by 12 weeks.

After 12 weeks, people taking Gemtesa had 2 fewer daily leakage episodes compared to 1 fewer episode in those taking placebo, 2 fewer bathroom visits (versus 1 fewer with placebo), and 3 fewer “urge to go” visits a day compared to 2 fewer with placebo. Continue reading

Does Gemtesa cause high blood pressure?

No, it isn’t common for Gemtesa (vibegron) to cause high blood pressure. In the phase 3 EMPOWUR trial of patients taking 75 mg of Gemtesa per day, Gemtesa had low rates of high blood pressure (1.7%) that were similar to placebo. Continue reading

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