mirabegron / Generic mfg. - LARVOL DELTA

Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH (clinicaltrials.gov) - P4 | N=270 | Recruiting | Sponsor: University of California, San Francisco

New P4 trial • Urinary Incontinence • Urology

Exploring the therapeutic potential of Beta-3 adrenergic agonists in overactive bladder: A comparative analysis of monotherapy versus combination therapy strategies. (PubMed, Wiad Lek) - " Beta-3 agonist as monotherapy is a potent, multimodality first-line therapy with strong influence of severe disease. Each of combinatory treatments show characteristic effect on phenotype-specific increase in bladder capacity. Mirabegron flaoxate could be considered for detrusor hypertrophy and combination of mirabegron Solifenacin would stimulate voiding facilitate. These proof of concept data justify PPTP based on objective biomarkers such as BWT and PVR to select combination therapy in what is another small step in our journey towards precision medicine for OAB."

Clinical • Journal • Monotherapy • Observational data • Overactive Bladder

The addition of mirabegron in pediatric lower urinary tract dysfunction: A large single-center experience. (PubMed, J Pediatr Urol) - "Mirabegron appears to be a safe and effective treatment for pediatric patients and should be considered as mono-therapy or in addition to other anticholinergic medication in lower urinary tract dysfunction."

Journal • Cardiovascular • Hypertension • Pain • Pediatrics • Psychiatry

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists (clinicaltrials.gov) - P1 | N=47 | Completed | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting ➔ Completed | N=100 ➔ 47

Enrollment change • Trial completion • Polyendocrine Metabolic Ovarian Syndrome

cAMP and cGMP pathways modulate spontaneous contractile activity in human seminal vesicle smooth muscle. (PubMed, Auton Neurosci) - "Pharmacological enhancement of cyclic nucleotide signaling reduced phenylephrine-induced hSV contractile activity. Rolipram showed the lowest apparent IC50. Mirabegron-sensitive relaxation together with ADRB3 transcript detection was compatible with possible β3-adrenoceptor involvement in hSV smooth muscle."

Journal

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics (clinicaltrials.gov) - P4 | N=96 | Recruiting | Sponsor: Philip Kern | Trial completion date: Aug 2026 ➔ Jan 2027 | Trial primary completion date: Aug 2026 ➔ Jan 2027

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

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

The Benefits of Adding Non-Antimuscarinic Pharmaceuticals in Combination With Beta-3 Agonists for Overactive Bladder Treatment: A Systematic Review. (PubMed, Neurourol Urodyn) - "There appear to be therapeutic benefits supporting the use of several different interventions in combination with a beta-3 agonist for the alleviation of overactive bladder symptoms. However, further research is needed due to limited evidence and heterogeneity."

Journal • Review • Overactive Bladder

ADEER: Effect of Antimuscarinic Treatment on Premature Ejaculation Severity in Men With Overactive Bladder: a Prospective Comparison With Mirabegron (clinicaltrials.gov) - P=N/A | N=40 | Completed | Sponsor: Ba?ak?ehir am & Sakura City Hospital | N=60 ➔ 40

Enrollment change • Overactive Bladder • Sexual Disorders

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

Exploratory clinical and urodynamic changes associated with mirabegron-containing multimodal treatment in children with non-monosymptomatic nocturnal enuresis: a retrospective real-world study. (PubMed, Front Pediatr) - "The retrospective, single-arm design precludes causal or treatment-specific inference, and patient-centered outcomes were not assessed. These findings are preliminary, exploratory, and hypothesis-generating rather than practice-informing."

Journal • Real-world evidence • Retrospective data • Overactive Bladder • Pediatrics • Urinary Incontinence • Urology

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

Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder (clinicaltrials.gov) - P=N/A | N=115 | Not yet recruiting | Sponsor: Bagcilar Training and Research Hospital

Biomarker • New trial • Inflammation • Overactive Bladder

A Modular Synthesis of C5-Sulfenyl Thiazoles via an Intermolecular Pummerer Rearrangement: An Underexplored Scaffold for Medicinal Chemistry. (PubMed, Angew Chem Int Ed Engl) - "The synthetic and medicinal impact of this methodology is showcased in the preparation and evaluation of thioether, sulfoxide and sulfone analogues of the blockbuster β3-adrenoceptor agonist mirabegron. Comparison of key pharmacokinetic properties revealed improved cell permeability, metabolic stability, lipophilicity and plasma protein binding without unduly affecting biological affinity relative to the parent drug."

Journal

Reply to Editorial Comment on "Quantitative assessment of additive effects of mirabegron and solifenacin in overactive bladder: re-analysis of SYNERGY study". (PubMed, Urology) - No abstract available

Journal • Overactive Bladder

Urine Epidermal Growth Factor/Creatinine Ratio in Female Patients with Overactive Bladder and Recurrent Lower Urinary Tract Infection. (PubMed, Gynecol Minim Invasive Ther) - "Patients with OAB were treated with either mirabegron (Betmiga®) or solifenacin succinate (Vesicare®) for 3 months. No significant difference in urine EGF/creatinine ratio was observed between control subjects and patients with OAB or recurrent lower UTI. Thus, urine EGF is not likely a useful marker for distinguishing between OAB and recurrent lower UTI."

Journal • Infectious Disease • Nephrology • Overactive Bladder • Xerostomia • EGF

ADEER: Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Men With Overactive Bladder (clinicaltrials.gov) - P=N/A | N=60 | Completed | Sponsor: Ba?ak?ehir am & Sakura City Hospital

New trial • Overactive Bladder • Sexual Disorders

Sex-Dependent Cardiac Responses to β3-Adrenergic Receptor Activation in a Murine Model of Heart Failure with Preserved Ejection Fraction. (PubMed, Biomedicines) - "Here, we investigated whether pharmacological activation of β3-AR using mirabegron modulates cardiac remodelling in a murine model of heart failure with preserved ejection fraction (HFpEF) induced by metabolic and hypertensive stress (MHS)... β3-AR activation is associated with sex-dependent cardiac responses in this HFpEF model, with more pronounced protective effects in males. These findings are consistent with a potential contribution of BAT activation to cardiac remodelling, although causality was not directly demonstrated in the present study."

Journal • Preclinical • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology

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

SQUARE PD: Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease (clinicaltrials.gov) - P4 | N=146 | Not yet recruiting | Sponsor: VA Office of Research and Development | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • CNS Disorders • Movement Disorders • Overactive Bladder • Parkinson's Disease

Clinical experience with mirabegron in pediatric patients with spina bifida under 3 years of age. (PubMed, J Pediatr Urol) - "Spina bifida patients with neurogenic bladder younger than 3 years old may benefit from additional therapy with beta-3 agonist, particularly those experiencing intolerable adverse effects from antimuscarinics."

Journal • Pediatrics

BEAM: Burden and Efficacy of Anticholinergic vs Mirabegron in Overactive Bladder - A Randomized Controlled Study (clinicaltrials.gov) - P4 | N=208 | Not yet recruiting | Sponsor: Universidade do Porto

New P4 trial • Overactive Bladder

Quantitative assessment of additive effects of mirabegron and solifenacin in overactive bladder: re-analysis of SYNERGY study. (PubMed, Urology) - "The efficacy of mirabegron-solifenacin combination therapy in OAB seems to be explained by additive IDA. Its clinical value lies in additive symptom control with preserved tolerability rather than synergistic interaction."

Journal • Overactive Bladder • Urinary Incontinence • Urology

Mechanisms for Activation of Beige Adipose Tissue in Humans (clinicaltrials.gov) - P2 | N=65 | Recruiting | Sponsor: Philip Kern | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Metabolic Disorders

Efficacy and Safety of Mirabegron for the Treatment of Bladder Dysfunction in the Pediatric Population: A Prospective Observational Study. (PubMed, Actas Urol Esp (Engl Ed)) - "Mirabegron demonstrated a favourable safety profile and was associated with clinically meaningful improvement in symptoms and urodynamic parameters, supporting its use in selected paediatric patients with lower urinary tract dysfunction."

Journal • Observational data • Cardiovascular • Overactive Bladder • Pediatrics • Urinary Incontinence • Urology