Vibegron for overactive bladder

Vibegron is a selective β3-adrenoceptor agonist which is approved for the use of symptomatic treatment of overactive bladder syndrome. A systematic review concludes that vibegron is well-tolerated, with a favorable safety profile (1).

Common or very common side effects include:

• constipation;
• diarrhoea;
• headache;
• nausea;
• urinary tract infection

Uncommon side effects include:

• hot flush;
• skin reactions;
• urinary disorders

Vibegron does not inhibit CYP2D6, a critical metabolic pathway for drugs commonly prescribed to older adults, such as donepezil, tramadol, and venlafaxine (2).

In the COURAGE trial, vibegron was safe and well tolerated in men with OAB symptoms and pharmacologically treated benign prostatic hyperplasia(BPH) (3).

NICE state (4):

• Vibegron is recommended as an option for treating the symptoms of overactive bladder syndrome in adults
  • it is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effect

The NICE committee noted:

• “…Clinical trial evidence shows that vibegron is more effective than placebo for treating the symptoms of overactive bladder syndrome. The evidence is limited because most people in the trial had not had antimuscarinic medicines. But the reduction in symptoms was similar for people who had had antimuscarinic medicines and people who had not. The licensed dose of vibegron (75 mg) has not been directly compared in a clinical trial with mirabegron, but an indirect treatment comparison suggests it is likely to work as well…”

Reference:

1. Shi H, Chen H, Zhang Y, Cui Y. The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials. Neurourol Urodyn. 2020 Jun;39(5):1255-1263.
2. Saadat H et al. Vibegron for overactive bladder in men with benign prostatic hyperplasia/obstruction: insights from the COURAGE trial. Transl Androl Urol. 2025 Apr 30;14(4):888-892.
3. Staskin D et al. 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. J Urol. 2024 Aug;212(2):256-266.
4. NICE (September 2024). Vibegron for treating symptoms of overactive bladder syndrome