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

Persistent bothersome urinary frequency following stereotactic body radiation therapy for clinically localized prostate cancer: rationale for prophylactic β3-agonist in men with elevated baseline international prostate symptom scores. (PubMed, Front Oncol) - "Answers to question 4E and tamsulosin usage were recorded at regular follow-ups to assess, and demographic factors as well as baseline prostate volume, alpha-adrenergic antagonist usage and IPSS score severity were used as modifiers. Prophylactic alpha-adrenergic antagonists do not protect against bothersome acute urinary frequency. This paper makes the case that urinary frequency may be better addressed with a prophylactic beta-3 agonist, like vibegron, which is designed to treat storage-related LUTS concerns."

Journal • Genito-urinary Cancer • Oncology • Overactive Bladder • Prostate Cancer • Solid Tumor

Validated LC-MS/MS Method for Vibegron Quantification in Human Plasma via a Selective Fragment Ion (m/z 135.1): Addressing Matrix Interference and Sample Instability. (PubMed, Biomed Chromatogr) - "The method demonstrated excellent linearity (0.500-400.223 ng/mL), precision (0.58%-3.34%), and accuracy (98.26%-102.29%), using only 100 μL of plasma. Fully compliant with ICH M10 guidelines, the method is well suited for future pharmacokinetic, bioavailability, and bioequivalence studies."

Journal

Exploring the therapeutic potential of beta-3 adrenergic agonists in overactive bladder: A comprehensive review. (PubMed, Med J Armed Forces India) - "The objective of this review was to understand the beta-3 signaling mechanisms in OAB and analyze the results of studies comparing mirabegron either as monotherapy or in combination with antimuscarinics for OAB treatment...In patients who are resistant to monotherapy, a combination therapy consisting of antimuscarinic agents and beta-3-agonists may be attempted. Primarily, this review emphasizes the role of beta-3 agonists in OAB in terms of their mechanism, safety, and efficacy in comparison with those of antimuscarinic drugs."

Journal • Review • Overactive Bladder • Urinary Incontinence • Urology

A novel electrochemical sensor for the analysis of vibegron as a newly approved FDA drug: a rational computational design and cleaning validation application. (PubMed, Anal Methods) - "The theoretical assumptions were practically verified by studying the selectivity of various electrodes with different studied ionophores towards vibegron and another structurally related molecule, mirabegron. This work also demonstrated the first use of electrochemistry during a cleaning validation protocol for monitoring any drug residues to ensure the effective cleaning of pharmaceutical manufacturing equipment with satisfactory recovery values. The proposed sensor was found to be a more sustainable, portable and faster sensing platform for these residues than conventional chromatographic methods."

FDA event • Journal

Effects of Treatment and Weather Variables on Nocturnal Enuresis: Long-Term Analysis Using the Classification and Regression Trees Model. (PubMed, Cureus) - "Our findings suggest that effective long-term management of NE may require individualized treatment plans that account for clinical and weather-related variables. Among weather-related variables, consideration of seasonal and environmental factors may be especially important in managing NE."

Journal • Pediatrics • Urinary Incontinence

Editorial Comment on: Use and Persistence of Beta-3 Adrenoceptor Agonists for the Treatment of Overactive Bladder. (PubMed, Int J Urol) - No abstract available

Journal • Overactive Bladder

Role of Combination Therapy in Women With Refractory Overactive Bladder (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: University of Alabama at Birmingham | N=54 ➔ 0 | Trial completion date: Dec 2026 ➔ Jan 2026 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Aug 2026 ➔ Jan 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Overactive Bladder

Restoring Control: A Medication Use Evaluation of Vibegron in the Treatment of Overactive Bladder (ASHP 2025) - No abstract available

Overactive Bladder

An updated meta-analysis of head-to-head trials comparing the efficacy, safety, and adherence of mirabegron and vibegron in overactive bladder. (PubMed, Medicine (Baltimore)) - "Recent data indicated that vibegron demonstrated superior efficacy in reducing urgency and UUI episodes while maintaining a safety profile comparable to mirabegron. Furthermore, vibegron is associated with improved treatment adherence. However, additional RCTs are necessary to confirm these findings."

Clinical • Head-to-Head • Journal • Retrospective data • Review • Overactive Bladder • Urinary Incontinence

Safety and efficacy of vibegron in pediatric patients with treatment-resistant nocturnal enuresis: a multicenter retrospective study. (PubMed, Transl Pediatr) - "Although enuresis alarms and desmopressin are the first-line treatments recommended by clinical guidelines, 20-40% of affected children demonstrate inadequate response and require additional therapeutic interventions. Add-on strategies-particularly triple therapy-were more effective than monotherapy switching, strengthening the incorporation of vibegron as part of multimodal treatment strategies. Given the retrospective nature of the study, prospective randomized trials are warranted to confirm these findings and optimize the treatment protocols."

Journal • Retrospective data • Pediatrics • Urinary Incontinence • Urology

Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial. (PubMed, Neurourol Urodyn) - P3 | "There were no safety signals related to bladder function identified by urodynamics; risk of protocol-defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population."

Journal • P3 data • Benign Prostatic Hyperplasia • Overactive Bladder

Use and Persistence of Beta 3-Adrenoceptor Agonists for the Treatment of Overactive Bladder. (PubMed, Int J Urol) - "The higher discontinuation rate of mirabegron may reflect the availability of vibegron as an alternative treatment option. The complementary use of both β3 agonists could play a key role in optimizing OAB management."

Journal • Overactive Bladder

Exploratory randomized comparison of mirabegron and vibegron as first-line therapy for overactive bladder in elderly women. (PubMed, Urology) - "Over 12 weeks, mirabegron and vibegron showed comparable efficacy and safety in pharmacotherapy-naïve elderly women with OAB. Given the single-center design and limited statistical power, these findings provide preliminary insights that may help guide the selection of first-line β3-adrenergic receptor agonists and highlight the need for larger multicenter trials."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Xerostomia

Radiation Nephritis Associated with Lutetium-177 Prostate-Specific Membrane Antigen (KIDNEY WEEK 2025) - "His outpatient medications include tadalafil 5 mg, vibegron 75 mg, testosterone cypionate 0.3 ml every 7 days, ezetimibe 10 mg, rosuvastatin 5 mg and insulin. Nephropathy attributed to binding of the drug to PSMA-like proteins expressed in the tubules leading to retention of beta emitter in the kidneys. Radiation renal injury is typically evident several months after irradiation."

Acute Kidney Injury • Diabetes • Genito-urinary Cancer • Hypertension • Metabolic Disorders • Nephrology • Prostate Cancer • Renal Disease • Solid Tumor

β3-Adrenoceptor Agonists for Neurogenic Lower Urinary Tract Dysfunction: Evidence and Clinical Rationale for First-Line Therapy. (PubMed, Neurourol Urodyn) - "β3-adrenoceptor agonists represent a safe, effective, and well-tolerated first-line option in NLUTD management. They preserve bladder safety and continence with fewer systemic side effects. OnabotulinumtoxinA remains an important escalation therapy for refractory cases but carries higher procedural and retention risks. A β3-agonist-based strategy offers a rational, patient-centered foundation for treatment."

Journal • Review • Cardiovascular • CNS Disorders • Multiple Sclerosis • Orthopedics

Target and off-target effects of vibegron on smooth muscle contraction of human detrusor and prostate tissues. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Similar to mirabegron, improvements of storage symptoms by vibegron involve mechanisms beyond inhibition of voiding contractions. Off-target effects occur with 10 µM, and include inhibition of neurogenic contractions and antagonism of prostatic α1A-adrenoceptors. Vibegron effects in the prostate may differ between patients with low BPH progression, and patients needing surgery for BPH."

Journal • Benign Prostatic Hyperplasia • Overactive Bladder

Main pharmacological differences between mirabegron and vibegron for the treatment of overactive bladder. (PubMed, Actas Urol Esp (Engl Ed)) - No abstract available

Journal • Overactive Bladder

Comparative assessment of oral medications for overactive bladder in older adults: a systematic review and network meta-analysis. (PubMed, Aging Male) - "In terms of reducing Micturitions, the interventions were ranked: trospium chloride (TRO), fesoterodine (FES) 4/8 mg, vibegron (VIB), mirabegron (MIR) 25/50 mg, tolterodine ER (TOL) 4 mg, placebo (PBO), of which only TOL showed no significant difference compared to placebo; Forsafety, the TEAE of TOL 4/8 mg had the highest incidence and was significantly different from others; MIR, VIB, and FES 4mg were well-tolerated regarding dry mouth and constipation; TOL 4 mg, FES 4/8 mg, and VIB showed a statistically increase from placebo for headache and FES 4/8mg and MIR 25 mg showed a statistically increase for dizziness. TRO 60 mg has the best efficacy in reducing micturitions, but increases the incidence of dry mouth and constipation; VIB and MIR are well tolerated in dry mouth and constipation, but may increase the risk of headache or dizziness."

Clinical • Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Pain • Xerostomia • MIR25

Prescribing patterns for beta-3 agonists and anticholinergic medications used in treatment of overactive bladder. (PubMed, Urology) - "Uptake of newer medications remains limited, particularly among non-specialists and in non-urban areas. These findings suggest that while newer drugs show distinct prescribing patterns, older medications remain widely prescribed due to broader adoption across specialties and practice settings."

Journal • Overactive Bladder

BEST: Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence (clinicaltrials.gov) - P4 | N=432 | Recruiting | Sponsor: Women and Infants Hospital of Rhode Island | Trial completion date: Jul 2027 ➔ Aug 2030

Trial completion date • Urinary Incontinence • Urology

Case presentation and overview of conservative and drug therapy (including Digas and Vibegron) (DGU 2025) - No abstract available

Clinical

Target and off-target effects of vibegron in smooth muscle contraction of human detrusor and prostate tissues suggest class effects of β3-agonists in storage symptoms (DGU 2025) - " In detrusor tissues, 100 nM vibegron reduced carbachol- and methacholine-induced contractions (p=0.0169, p=0.0115), while inhibitory effects were lacking with 10 nM, 1 µM and 10 µM. Similar to mirabegron, improvements of storage symptoms by vibegron may be imparted by mechanisms other than inhibition of voiding contractions, as inhibition of cholinergic contractions occurs with low consistency. Off-target effects in preclinical models occur with 1-10 µM, and include inhibitions of neurogenic contractions and antagonism of prostatic α1A-adrenoceptors. Vibegron effects in the prostate may differ between patients with slow BPH progression, and patients needing surgery for BPH."

Genito-urinary Cancer • Prostate Cancer • Solid Tumor

Critical insights on vibegron in overactive bladder: a comprehensive review of efficacy, safety and patient-reported outcomes. (PubMed, World J Urol) - No abstract available

Journal • Overactive Bladder

Comment on: "Vibegron in overactive bladder: a comprehensive review of efficacy, safety and patient-reported outcomes". (PubMed, World J Urol) - No abstract available

Journal • Overactive Bladder

Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: University of Missouri-Columbia | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date