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

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

Identification of potential alternatives for isoniazid: An in silico molecular dynamics study. (PubMed, J Mol Graph Model) - "Our simulations revealed that Bictegravir and Vibegron demonstrated strong electrostatic interactions and favourable binding energies, making them a potential candidate for TB treatment. This computational approach provides a foundation for discovering safer and more effective therapies against both drug-sensitive and drug-resistant TB strains."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Clinically Meaningful Improvements With Vibegron in Men With Overactive Bladder and Benign Prostatic Hyperplasia: A Responder Analysis of the Phase 3 COURAGE Trial. (PubMed, Urology) - P3 | "In this post hoc responder analysis from the phase 3 COURAGE trial, participants receiving vibegron vs placebo achieved clinically relevant reductions in bothersome OAB symptoms, as well as improvements in IPSS and OAB-q scores."

Journal • P3 data • Benign Prostatic Hyperplasia • Overactive Bladder • Urinary Incontinence • Urology

Vibegron in overactive bladder: a comprehensive review of efficacy, safety and patient-reported outcomes. (PubMed, World J Urol) - "Vibegron represents an important advance in the pharmacologic management of OAB, providing a well-tolerated and effective alternative to existing therapies."

Journal • Review • Benign Prostatic Hyperplasia • Cardiovascular • Overactive Bladder • Urinary Incontinence • Urology

Comparison of the Efficacy of Vibegron and Fesoterodine for Neurogenic Detrusor Overactivity in Individuals With Spinal Cord Lesion: A Single-Center Prospective Randomized Crossover Trial. (PubMed, Neurourol Urodyn) - "Vibegron significantly improved CMG parameters in addition to alleviating UI symptoms, demonstrating efficacy that was not inferior to that of fesoterodine. With a lower incidence of adverse events and high patient satisfaction, vibegron may serve as a useful therapeutic option for the treatment of NDO in individuals with SCL."

Journal • CNS Disorders • Orthopedics

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 | Trial completion date: Jun 2027 ➔ Jul 2028 | Initiation date: Jul 2025 ➔ Aug 2026 | Trial primary completion date: Jun 2027 ➔ Jul 2028

Trial completion date • Trial initiation date • Trial primary completion date • Genetic Disorders • Obesity

Effect of β3-adrenergic receptor agonists on [18F] fluorodeoxyglucose uptake in brown adipose tissues in positron emission tomography images of elderly patients. (PubMed, EJNMMI Res) - "In patients aged ≥ 60 years, β3-adrenergic receptor agonist therapy appears to be associated with increased [18F]FDG BAT uptake, particularly in the perirenal area."

Journal • Overactive Bladder

Letter to the Editor on "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) - No abstract available

Journal • Retrospective data • Overactive Bladder

Stability and Activity Collaborative Improvement of Carbonyl Reductase Based on the Modification Strategy for Transition Zone of the Flexible and Rigid Regions: An Application for Vibegron Chiral Intermediate Synthesis in High Efficiency. (PubMed, J Agric Food Chem) - "A conversion of 97% was achieved within 36 h at a total substrate concentration of 200 g/L, accompanied by >99% enantiomeric excess (e.e) and >99% diastereomeric excess (d.e). This study presents a practical approach for enhancing enzyme performance and advancing green chiral alcohol synthesis."

Journal