Beova (vibegron) / Merck (MSD), Kissei, Kyorin, Sumitomo Pharma, Jeil, Pierre Fabre, Knight Therap - LARVOL DELTA

Comparative efficacy and adverse effects of β3-agonists and antimuscarinics in overactive bladder: a network and component network meta-analysis. (PubMed, Eur J Clin Pharmacol) - "β3-agonists, especially vibegron, are effective for OAB symptoms (MF and UUI), both alone and with antimuscarinics. For short-term treatment, combination therapies seem superior to monotherapies in symptom control."

Adverse events • Journal • Retrospective data • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Urinary Incontinence • Urology • Xerostomia

Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity (clinicaltrials.gov) - P3 | N=40 | Not yet recruiting | Sponsor: Wake Forest University Health Sciences

New P3 trial • Genetic Disorders • Obesity

Updated Budget Impact Analysis of Vibegron for the Treatment of Overactive Bladder in the United States (ISPOR 2025) - "Vibegron continues to have modest budget impact to health plans despite introduction of generic mirabegron. Improved outcomes and reduced costs associated with decreased ACB and fewer drug-drug interactions may partially offset increased pharmacy costs."

HEOR • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Musculoskeletal Diseases • Orthopedics • Overactive Bladder

Vibegron for overactive bladder in men with benign prostatic hyperplasia/obstruction: insights from the COURAGE trial. (PubMed, Transl Androl Urol) - No abstract available

Journal • Benign Prostatic Hyperplasia • Overactive Bladder

Sumitomo Pharma America Presents New Data on Vibegron at the 2025 American Urological Association Annual Meeting (PRNewswire) - P3 | N=276 | COURAGE (NCT04103450) | Sponsor: Urovant Sciences GmbH | "Data presented from the Phase 3 COURAGE trial (URO-901-3006) included a total of 276 men with OAB symptoms receiving pharmacological therapy for BPH who participated in the open-label extension study. The primary outcome was to evaluate the long-term safety of vibegron 75 mg, which was well tolerated for up to 52 weeks in men with symptoms of OAB who were receiving pharmacological treatment for BPH....Sustained efficacy results in all secondary outcomes were observed, including mean daily micturitions, urgency episodes, nocturia episodes, urge urinary incontinence episodes, IPSS-Storage and volume voided per micturition. Vibegron demonstrated favorable long-term safety and efficacy, with no new safety signals compared to prior OAB studies."

P3 data • Overactive Bladder

Sumitomo Pharma America Presents New Data on Vibegron at the 2025 American Urological Association Annual Meeting (PRNewswire) - P=Obs | N=403 | Composur (NCT05067478) | Sponsor: Urovant Sciences GmbH | "At the conference SMPA also shared findings from the Phase 4 COMPOSUR, real-world study of vibegron in patients with OAB, which continue to support that it was generally safe and well-tolerated, with the majority of patients satisfied with treatment and remaining on vibegron after 12 months. Most common adverse events were urinary tract infection (4.0%), headache (2.7%), dizziness (2.2%) and diarrhea (2.0%)."

Observational data • Real-world • Overactive Bladder

Role of Combination Therapy in Women With Refractory Overactive Bladder (clinicaltrials.gov) - P=N/A | N=54 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: Jan 2026 ➔ Dec 2026 | Initiation date: Apr 2025 ➔ Sep 2025 | Trial primary completion date: Oct 2025 ➔ Aug 2026

Trial completion date • Trial initiation date • Trial primary completion date • Overactive Bladder

Real-World Outcomes of Vibegron in Patients With Overactive Bladder: Results From the Phase 4 COMPOSUR Study (AUA 2025) - P | " COMPOSUR (NCT05067478) was a 12-month, phase 4 study that enrolled patients≥18 years old with OAB, with or without urge urinary incontinence, starting a new course of vibegron, who were previously prescribed anticholinergics or mirabegron with or without anticholinergics. In this phase 4, real-world study, most patients receiving vibegron were satisfied with treatment. At 12 months, 59.8% of patients remained on vibegron. Vibegron was generally safe and well tolerated."

Clinical • P4 data • Real-world • Real-world evidence • Infectious Disease • Nephrology • Overactive Bladder • Pain • Urinary Incontinence

Influence of Anticholinergic Burden, Polypharmacy, and Treatment History on Continuation of Vibegron in Super-Elderly Overactive Bladder Patients (AUA 2025) - "Additionally, prior OAB treatments were categorized as no treatment, anticholinergic-only, or mirabegron-only therapy. Vibegron showed consistent continuation rates in super-elderly OAB patients, regardless of prior treatments, highlighting its value as a long-term option that reduces anticholinergic burden. Sustaining OAB therapy in this population is critical to decreasing risks such as falls and cognitive decline, particularly given the high rates of polypharmacy. Clinicians should account for overall medication load and anticholinergic burden to enhance adherence and outcomes in super-elderly OAB patients."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Diseases • Orthopedics • Overactive Bladder • Xerostomia

Vibegron effects in isolated human tissues suggest inhibition of detrusor microcontractions during improvement of storage symptoms, and preclude effects on voiding symptoms despite off-target antagonism of α1A (AUA 2025) - "Similar to mirabegron, vibegron may improve storage symptoms by inhibition of microcontractions or via neuronal β3-adrenoceptors, rather than inhibition of full voiding contractions. Improvements of voiding symptoms by antagonism of α1 can not be expected. Inhibition of full voiding contractions in the human detrusor and antagonism of α1-adrenoceptors in the human prostate require concentrations highly exceeding predicated plasma levels (55 nM) of vibegron."

The Phase 3 Open-Label COURAGE Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder Symptoms on Pharmacotherapy for Benign Prostatic Hyperplasia (AUA 2025) - "Vibegron demonstrated favorable long-term safety and efficacy for up to 52 weeks in men with OAB symptoms receiving pharmacologic treatment for BPH."

Clinical • P3 data • Benign Prostatic Hyperplasia • Cardiovascular • Hypertension • Infectious Disease • Novel Coronavirus Disease • Overactive Bladder • Urinary Incontinence

Comparison of efficacy and safety of mirabegron and vibegron in the treatment of Overactive Bladder (OAB) in older women: A systematic review and meta-analysis. (PubMed, PLoS One) - "There appears to be no statistically significant difference in efficacy and safety between mirabegron and vibegron for OAB patients. Further high-quality prospective studies are needed to confirm these results."

Clinical • Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Xerostomia

β3-Adrenoceptor Agonist Effects on the Urinary Bladder Beyond Detrusor Relaxation. (PubMed, Neurourol Urodyn) - "Further long-term studies with β3-adrenoceptor agonists are needed to clarify the role of such processes in clinical improvement of patients with overactive bladder syndrome occurring at time points later than 4 weeks after initiation of treatment."

Journal • Review • Fibrosis • Immunology • Overactive Bladder

Benigne Prostatahyperplasie: Vibegron bei Drangbeschwerden effektiv und sicher. (PubMed, Aktuelle Urol) - No abstract available

Journal

Satisfaction and persistence with vibegron in the first 6 months of overactive bladder treatment: interim results of the phase 4, real-world COMPOSUR study. (PubMed, BMC Urol) - P | "As of the 6-month interim analysis of the COMPOSUR study, most patients receiving vibegron were satisfied with treatment; satisfaction generally persisted from month 1 to 6, regardless of prior OAB treatment received. Treatment with vibegron was generally safe and well tolerated."

Journal • P4 data • Real-world evidence • Infectious Disease • Nephrology • Overactive Bladder • Pain • Urinary Incontinence • Urology

Suitability of Crushed Vibegron 75 mg Tablets for Enteral Administration. (PubMed, Sr Care Pharm) - "Mean dose delivery was > 95% for all tubes assessed and not significantly different between tubes (F = 1.02; P = 0.4). Conclusions Crushed vibegron tablets dispersed in 15 mL of water were delivered consistently and completely through a variety of enteral tubes with no evidence of material incompatibility or clogging."

Journal • Gastrointestinal Disorder • Overactive Bladder

Add-on or switch to vibegron in patients with overactive bladder insufficiently responding to initial 4-week antimuscarinics: a randomised, parallel-group, multicentre trial (ADVISR) protocol. (PubMed, BMJ Open) - "Results will be reported in a separate publication. Japan Registry of Clinical Trials (jRCT) (jRCTs031240134)⁠."

Clinical • Clinical protocol • Journal • Overactive Bladder • Urinary Incontinence • Urology

Disproportionality analysis of vibegron-associated adverse events using the FDA adverse event reporting system (FAERS): a real-world pharmacovigilance study. (PubMed, Eur J Med Res) - "This study provides comprehensive insights into vibegron's safety profile, revealing both known and unexpected AEs. The findings highlight the need for careful patient selection and monitoring, especially among females and the elderly. The results advocate for ongoing pharmacovigilance and further research to ensure vibegron's safe and effective use in OAB treatment."

Adverse events • Journal • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Xerostomia

Comparative efficacy and safety of mirabegron and vibegron in female patients with overactive bladder: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Urology) - "In female OAB patients, the efficacy and safety of mirabegron and vibegron were similar. Vibegron may be more effective than mirabegron in relieving urgency urinary incontinence."

Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Urinary Incontinence • Urology • Xerostomia

Impact of Anticholinergic Burden, Polypharmacy, and Prior Treatments on Vibegron Continuation in Super-Elderly Patients with Overactive Bladder (EAU 2025) - No abstract available

Clinical • Overactive Bladder

Plain Language Summary of Publication: What is the effect of the medicine vibegron in the treatment of overactive bladder in patients with and without bladder leakage? (PubMed, Ther Adv Urol) - "The study also included another drug that was already available for treating overactive bladder called tolterodine and a pill with no medicine called a placebo. What do the results mean? This study suggests that vibegron can improve symptoms in people with overactive bladder whether or not they have accidental bladder leakage."

Journal • Review • Overactive Bladder

Trends in Medicare Coverage of Overactive Bladder Medications in the United States. (PubMed, Urogynecology (Phila)) - "Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction."

Journal • Medicare • Reimbursement • US reimbursement • Cognitive Disorders • Overactive Bladder

Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB) (clinicaltrials.gov) - P=N/A | N=403 | Completed | Sponsor: Urovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • Overactive Bladder

Sumitomo Pharma America Announces U.S. FDA Approval of GEMTESA (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia (PRNewswire) - "Sumitomo Pharma America, Inc...announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH)...The FDA's approval of GEMTESA is based on results from URO-901-3005, a Phase 3 study of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH."

FDA approval • Benign Prostatic Hyperplasia • Overactive Bladder

Plain Language Summary of Publication: Does crushing vibegron 75 mg tablet affect its safety or the amount of vibegron in the body over time in healthy adults? (PubMed, Ther Adv Urol) - "Where can I find the original article on which this summary is based? The original article is called "Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults." You can read the original article published in Clinical Pharmacology in Drug Development at this link: • https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1169."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Pain