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

Real-World Outcomes of Vibegron in Patients With Overactive Bladder: Results From the Phase 4 COMPOSUR Study (AUA 2025) - No abstract available

Clinical • P4 data • Real-world • Real-world evidence • Overactive Bladder

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) - No abstract available

Influence of Anticholinergic Burden, Polypharmacy, and Treatment History on Continuation of Vibegron in Super-Elderly Overactive Bladder Patients (AUA 2025) - No abstract available

Clinical • Overactive Bladder

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) - No abstract available

Clinical • P3 data • Benign Prostatic Hyperplasia • Overactive Bladder

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

Comparison of the 3-Year Continuation Rate and Discontinuation Factors Between Vibegron and Mirabegron in Patients With Overactive Bladder: A Retrospective Follow-Up Study in a Rehabilitation Hospital in Japan. (PubMed, Low Urin Tract Symptoms) - "Vibegron was superior to mirabegron in the 3-year continuation rate of administration with a fewer discontinuation due to inadequate efficacy in a patient population with relatively high rates of neurogenic overactive bladder."

Clinical • Journal • Retrospective data • Overactive Bladder

Comparative Efficacy and Safety of the β3-Adrenoceptor Agonist Vibegron for Urgency and Mixed Urinary Incontinence: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. (PubMed, Cureus) - "Conclusion This post hoc analysis demonstrated that vibegron has equivalent efficacy and safety in the MUI and UUI populations. The results of this study provide important information for the treatment of MUI."

Clinical • Journal • P3 data • Retrospective data • Overactive Bladder • Urinary Incontinence • Urology

A Novel Spectrofluorimetric Method for Vibegron in the Newly FDA Approved Pharmaceutical Formulation and in Human Plasma: Analytical QbD Strategy for Method Development and Optimization. (PubMed, J Fluoresc) - "The proposed method expressed good capability in assaying the marketed dosage forms with no excipient inference. Finally, the high sensitivity of such method paved the way for extending its application to quantify vibegron in spiked human plasma at concentrations around its real human plasma concentrations for further bioavailability studies."

FDA event • Journal • Overactive Bladder

Robotic Sacrocolpopexy: Type of Suture Does Matter (AAGL 2024) - "She was treated with vibegron for overactive bladder with minimal improvement... Suture erosion is an infrequent, but important complication and should be considered in patients with refractory overactive bladder after POP surgery. A monofilament non-absorbable suture should not be used under the bladder due to the risk of erosion through the thin bladder wall. Suture erosion into the bladder from an adjacent site can be removed safely and effectively with minimal risk with robotic assisted surgical technique."

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 | Initiation date: Sep 2024 ➔ Apr 2025

Trial initiation date • Overactive Bladder

Urodynamic findings and vibegron effects on neurogenic lower urinary tract dysfunction caused by human T-cell leukemia virus type I-associated myelopathy/tropical spastic paraparesis. (PubMed, IJU Case Rep) - "Switching from solifenacin to vibegron improved OAB symptoms. In patients for whom OAB and DO do not improve with steroid treatment and solifenacin, treatment with vibegron may improve OAB symptoms."

Journal • Genetic Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Overactive Bladder

Safety and Effectiveness of Vibegron in Japanese Patients With Overactive Bladder: A Japanese Postmarketing Survey. (PubMed, Low Urin Tract Symptoms) - "This survey found no major concerns regarding the safety and effectiveness of vibegron in Japanese OAB patients, except for urinary retention-related AEs. Vibegron is considered to represent a useful drug for treating OAB symptoms in a real-world clinical setting."

Journal • P4 data • Benign Prostatic Hyperplasia • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Xerostomia

Reply: Letter: 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 COURAGE Trial. (PubMed, J Urol) - No abstract available

Journal • P3 data • Benign Prostatic Hyperplasia • Overactive Bladder

Improving the catalytic performance of carbonyl reductase based on the functional loops engineering. (PubMed, Biotechnol Bioeng) - "Under organic-aqueous biphasic conditions, the M5 mutant showed >99% conversion within 12 h with 300 g/L substrate 1a (highest substrate loading as reported). This study enhanced the catalytic performance of carbonyl reductase through functional loops engineering and established a robust framework for the large-scale biosynthesis of the vibegron intermediate."

Journal

Letter: 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. (PubMed, J Urol) - No abstract available

Journal • P3 data • Benign Prostatic Hyperplasia • Overactive Bladder

Pantothenate kinase: A promising therapeutic target against pathogenic Clostridium species. (PubMed, Heliyon) - "During the molecular screening of 1201 compounds, a known agonist drug compound (Vibegron) showed strong inhibitory activity against targeted clostridial CoaX. Additionally, we identified tazobactam, a beta-lactamase inhibitor, as effective against the newly proposed target, CoaX. Therefore, identifying CoaX as a single drug target effective against all four clostridial pathogens presents a valuable opportunity to develop a cost-effective treatment for multispecies clostridial infections."

Journal • Infectious Disease

Letter: 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. (PubMed, J Urol) - No abstract available

Journal • P3 data • Benign Prostatic Hyperplasia • Overactive Bladder

The Effects of Vibegron Add-on Therapy on Alpha 1-Blocker Therapy for Sexual Function and Overactive Bladder Symptoms in Benign Prostatic Hyperplasia: A Prospective, Open-Label Study. (PubMed, J Clin Med) - "No significant differences were observed for the IPSS, EHS, total IIEF-15 score, residual urine volume, and serum FT and CRP levels. The study findings suggest that vibegron/α1-blocker combination therapy improves OAB and sexual satisfaction."

Journal • Benign Prostatic Hyperplasia • Overactive Bladder • Urology • CRP