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

Knight Therapeutics Announces Regulatory Submission of GEMTESA in Canada (Knight Therapeutics Press Release)

Canada filing • Benign Prostatic Hyperplasia • Overactive Bladder • Renal Disease

Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Missouri-Columbia | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular

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 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date

Efficacy of Vibegron in Overactive Bladder: A Bayesian Cross-Trial Synthesis of Benefit Probabilities and Decision Thresholds. (PubMed, Low Urin Tract Symptoms) - "Bayesian cross-trial synthesis demonstrates a high probability that vibegron improves key OAB voiding-diary outcomes at Week 12. By explicitly quantifying the probability of exceeding clinically interpretable decision thresholds, this approach provides a transparent assessment of both the direction and magnitude of treatment effects, facilitating clinically interpretable decision-making."

Clinical • Journal • Overactive Bladder • Urinary Incontinence • Urology

Pharmacokinetics of phosphodiesterase type 5 inhibitors and β-adrenergic receptor type 3 agonists for benign prostatic hyperplasia. (PubMed, Expert Opin Drug Metab Toxicol) - "Included studies in this literature review and expert opinion were found using PubMed.Expert Opinion Mirabegron, vibegron and tadalafil appear to be safe and efficacious medications in treatment of LUTS. Further studies are needed to understand the role of pharmacogenetics and use of these medications after surgical treatment. Thus, phosphodiesterase type 5 inhibitors and β-adrenergic receptor type 3 agonists are important tools in the urologist's toolbox for treatment of BPH."

Journal • PK/PD data • Review • Benign Prostatic Hyperplasia • Overactive Bladder

Design, synthesis and pharmacological characterisation of fluorescent ligands for the human beta-3 adrenceptor (β3AR) | Poster Board #1043 (ACS-Fall 2026) - "Mirabegron and vibegron are clinical β3AR agonists used for treating overactive bladder, yet off target binding at β1AR and β2AR can potentially result in cardiovascular and respiratory side effects. Figure 1: The β3AR does not undergo agonist-induced desensitisation and internalisation, making it a valuable target for treating chronic conditions requiring long-term drug intervention. Fluorescent ligands can be useful in understanding β3AR signalling dynamics and novel agonist binding."

Cardiovascular • Genetic Disorders • Obesity • Overactive Bladder

Sex- and Age-Specific Trends in Prescriptions of Beta-3 Agonists and Anticholinergics in Japan: A Nationwide Prescription Database Study. (PubMed, Low Urin Tract Symptoms) - "A nationwide shift in overactive bladder treatment, where the growth in β3-agonist prescriptions outweighed the decline in anticholinergics, was observed across all demographic groups in Japan."

Journal • Overactive Bladder

Second- and third-line treatment options for refractory monosymptomatic enuresis in children: a scoping review. (PubMed, Eur J Pediatr) - "The results showed that, following first-line treatment, a combination of biofeedback, electrical nerve stimulations, anticholinergics (e.g. oxybutynin, tolterodine, solifenacin), β3-adrenoceptor agonists (e.g. vibegron), tricyclic antidepressants (e.g. imipramine) and selective serotonin reuptake inhibitor (e.g. fluoxetine) improved both partial response (PR) and complete response (CR) at varying rates across highly heterogeneous interventions and study populations...Furthermore, reports on electro-acupuncture, furosemide, onabotulinumtoxin A injections or the herbal medicine 'shokenchuto' were considered unreliable for pure refractory MNE, despite improvements in PR and CR occurring at different rates...Some second- and third-line treatment options may improve PR and CR rates, despite the limited available evidence to support a treatment algorithm. However, further research is needed to confirm these benefits."

Clinical • Journal • Review • Pediatrics • Urinary Incontinence

Comparing the safety and efficacy of vibegron, mirabegron and tolterodine in patients with overactive bladder: a systematic review and network meta-analysis. (PubMed, Eur J Obstet Gynecol Reprod Biol) - "Vibegron appears to rank more favourably for improvement in episodes of UU, UUI and maximum voided volume per void, when compared to mirabegron and tolterodine. Mirabegron ranks more favourably for improvement in episodes of urinary frequency over 24 h. Mirabegron is least likely to be associated with hypertension, although reporting of adverse events is non-standardised and therefore may not be comparable. This network meta-analysis does not account for other factors which may influence drug therapy choice i.e. contraindications, difficulties with swallowing and available treatment options."

Journal • Retrospective data • Review • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypertension • Infectious Disease • Nephrology • Overactive Bladder • Xerostomia

Management of Persistent Storage Symptoms and Overactive Bladder in Men Diagnosed with Benign Prostatic Hyperplasia: A Narrative Review. (PubMed, Adv Ther) - "Proactive discussions about symptoms, especially in the primary care setting, may help facilitate timely and effective treatment of this common issue. There are established OAB treatments that can be safely and successfully combined with BPH management to effectively address persistent storage symptoms and complex urinary symptoms in men."

Journal • Review • Benign Prostatic Hyperplasia • Overactive Bladder

Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University of Missouri-Columbia

New P1 trial • Cardiovascular

BEST: Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence (clinicaltrials.gov) - P4 | N=432 | Active, not recruiting | Sponsor: Women and Infants Hospital of Rhode Island | Recruiting ➔ Active, not recruiting

Enrollment closed • Urinary Incontinence • Urology

KANGUROO: Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC (clinicaltrials.gov) - P2/3 | N=71 | Recruiting | Sponsor: Urovant Sciences GmbH | Trial completion date: Sep 2027 ➔ Sep 2030 | Trial primary completion date: Jan 2027 ➔ Mar 2030

Trial completion date • Trial primary completion date • Pediatrics

Navigating the challenges of overactive bladder management in women. (PubMed, World J Urol) - "Further research into underlying mechanisms, long-term outcomes and strategies to optimise treatment adherence will be essential to improve symptom control and quality of life for women living with OAB."

Journal • Review • Cardiovascular • Overactive Bladder • Women's Health

Evaluating sexual function in men treated with vibegron for overactive bladder while on pharmacological therapy for benign prostatic hyperplasia: exploratory analysis from the phase 3 COURAGE trial (AUA 2026) - P3 | "No clinical effect on sexual function as assessed via IIEF or IPSS QoL was observed with vibegron treatment. Although the presence of β3 receptors in corporal tissue may promote corporal relaxation, there was no discernible clinical augmentation or diminution of erectile function. Further research on β3 agonists utilizing erectile dysfunction as the primary outcome is recommended."

P3 data • Benign Prostatic Hyperplasia • Erectile Dysfunction • Overactive Bladder • Sexual Disorders

Analysis of Temporal Trends in Anticholinergic and ß3 Agonist Prescription Patterns in the United States Pediatric Population (AUA 2026) - "Annual rates and cost of anticholinergic (darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, trospium) and β3 agonist (mirabegron, vibegron) prescriptions were determined by drug type and insurance. Anticholinergic prescription rates in children decreased, with rates in the Medicaid and commercially insured populations converging. β3 agonist prescription rates were low but increased substantially and were higher among commercially insured patients. Anticholinergic costs were similar between groups, while β3 agonist prescriptions cost nearly twice as much for commercially insured patients."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia • Overactive Bladder • Pediatrics

Efficacy and safety of vibegron in men =75 years of age with symptoms of overactive bladder on pharmacotherapy for benign prostatic hyperplasia: a subgroup analysis of the COURAGE trial (AUA 2026) - P3 | "Vibegron was associated with substantial improvements in clinical efficacy outcomes vs placebo and was safe and well tolerated in men ≥75 y with persistent OAB symptoms on pharmacotherapy for BPH, comparable to men <75 y."

Clinical • Benign Prostatic Hyperplasia • Cardiovascular • Hypertension • Infectious Disease • Overactive Bladder • Respiratory Diseases • Urinary Incontinence

Vibegron for Anticholinergic-Resistant Pediatric Neurogenic Lower Urinary Tract Dysfunction After Spinal Cord Amputation: A Case Report. (PubMed, IJU Case Rep) - "Despite CIC and solifenacin, he continued to experience daily urinary incontinence. Over 24 months, no urinary tract infections, incontinence episodes, or drug-related adverse events occurred. This case suggests that vibegron may be an effective, well-tolerated add-on therapy for pediatric patients with anticholinergic-resistant NLUTD after spinal cord surgery, improving bladder function and morphology while helping maintain quality of life."

Journal • Infectious Disease • Nephrology • Pediatrics • Urinary Incontinence • Urology

Making the Most of Pharmacologic Interventions: Urodynamic Effects of Different Therapies for Neurogenic Lower Urinary Tract Dysfunction Following Spinal Cord Injury. (PubMed, Eur Urol Focus) - "Anticholinergics, β-3 agonists, and onabotulinumtoxin A (BTX-A) are guideline-supported pharmacotherapies. We found that β-3 agonists, particularly vibegron, and anticholinergics make meaningful changes in overactive bladder on UDS, although β-3 agonists may be better tolerated. BTX-A is highly effective even when oral options fail."

Journal • Review • CNS Disorders • Orthopedics • Overactive Bladder

Real-world persistence of vibegron in patients aged ≥ 80 years with overactive bladder: a multicenter cohort study. (PubMed, World J Urol) - "In patients aged ≥ 80 years initiating vibegron, polypharmacy was associated with shorter treatment persistence after matching, whereas ACB and prior anticholinergic exposure were not. These findings suggest that overall medication burden and care-related factors, rather than anticholinergic burden alone, may influence long-term persistence of OAB therapy in super-elderly patients."

Journal • Real-world evidence • Retrospective data • Overactive Bladder • Urology

Synergistic CRISPR-Cas9 Host Engineering and Enzyme Evolution for Enantioselective Synthesis of a Vibegron Pyrrolidine Intermediate. (PubMed, Org Lett) - "Here we report an imine reductase (IRED) catalyzed asymmetric imine reduction to access a key vibegron intermediate. Directed evolution afforded a highly efficient variant delivering 94% conversion and >99% d.e. Combined enzyme and host engineering enabled clean whole cell catalysis, establishing a robust and scalable biocatalytic platform."

Journal

Efficacy and Safety of Vibegron Add-On Therapy for Persistent Overactive Bladder Symptoms in Benign Prostatic Hyperplasia Patients With α1-Blocker Treatment: A Multi-Center Prospective Randomized Controlled Study (VATON Study). (PubMed, Low Urin Tract Symptoms) - "Vibegron add-on therapy to an α1-blocker may be effective and safe for treating BPH with persistent OAB symptoms."

Clinical • Journal • Benign Prostatic Hyperplasia • Overactive Bladder

The effect of anticholinergics and β-3 agonists on erectile function: a narrative review. (PubMed, Sex Med Rev) - "OAB pharmacotherapy may influence male sexual health; however, evidence remains mixed. Further high-quality research is needed to elucidate these relationships and guide individualized treatment strategies that address both urinary and sexual function in men."

Journal • Overactive Bladder

Microwave-assisted N,S doped carbon quantum dots as fluorescent nanoprobes for vibegron determination: face-centered design optimization, validation, and green chemistry assessment. (PubMed, RSC Adv) - "Furthermore, spiked human plasma analysis demonstrated recoveries ranging from 96.44% to 104.28% with RSD values below 4%, confirming applicability to biological matrices for therapeutic drug monitoring. Comprehensive green chemistry assessment using AGREE (0.65), CaFRI (80/100), and BAGI (70.0/100) metrics demonstrated favorable environmental sustainability characterized by minimal hazardous reagent consumption, low carbon footprint, reduced waste generation, and excellent practical applicability, providing an environmentally benign analytical tool for routine pharmaceutical quality control and therapeutic drug monitoring applications."

Journal

Effects of Vibegron, a β3-Adrenoceptor Agonist, on Lower Urinary Tract Dysfunction in Diabetic Rats. (PubMed, Low Urin Tract Symptoms) - "These findings suggest that vibegron may be a promising therapeutic option for addressing detrusor overactivity, ischemia, and inflammation of the bladder associated with diabetes mellitus."

Journal • Preclinical • Cardiovascular • Diabetes • Metabolic Disorders • Oncology • HIF1A • TGFB1 • TNFA