mirabegron / Generic mfg. - LARVOL DELTA

NI-UUI-2025: Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Emilio José Dávila Álvarez | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Urinary Incontinence • Urology

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

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

Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Obstetrics & Gynecology Hospital of Fudan University

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Trial completion date: Mar 2026 ➔ Mar 2030 | Trial primary completion date: Mar 2026 ➔ Mar 2030

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

Urologic Symptom Management in Parkinson's Disease - Current Treatments and Emerging Directions - Systematic Review. (PubMed, Curr Urol Rep) - "In contrast, beta-3 agonists such as mirabegron offer a safer cognitive profile with emerging efficacy data...Optimal management of LUTS in PD requires individualized, stage-specific, multidisciplinary strategies balancing efficacy and cognitive safety. Further high-quality, disease-specific studies are essential to develop tailored treatment algorithms and improve quality of life in this growing patient population."

Journal • Review • CNS Disorders • Movement Disorders • Overactive Bladder • Parkinson's Disease • Urinary Incontinence • Urology

NI-UUI-2025: Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: Emilio José Dávila Álvarez

Head-to-Head • New trial • Urinary Incontinence • Urology

A systematic review and meta-analysis of the efficacy and safety of mirabegron vs. tamsulosin in alleviating double-J catheter related symptoms. (PubMed, Front Med (Lausanne)) - "Further large-scale, high-quality RCTs with longer follow-up periods and comprehensive safety data are needed to confirm these findings and identify patient groups who may benefit most from mirabegron treatment. https://www.crd.york.ac.uk/prospero/, CRD420251083374."

Journal • Retrospective data • Review • Hypotension • Renal Calculi

Efficacy and Safety of Mirabegron in Males with Overactive Bladder and Lower Urinary Tract Symptoms: Analysis from an Integrated Database. (PubMed, Eur Urol Open Sci) - "The studies had four treatment arms-(1) mirabegron beginning with 25 mg and then escalated to 50 mg (25/50 mg), (2) mirabegron 50 mg, (3) mirabegron 25/50 mg + tamsulosin hydrochloride (HCl) 0.4 mg, and (4) mirabegron 50 mg + tamsulosin HCl 0.2 mg, and three cohorts-cohort 1, OAB males overall; cohort 2, OAB males with concomitant BPE taking alpha blockers; and cohort 3, OAB males with concomitant BPE taking other LUTS medications (not alpha blockers). The analyzed patients included those taking mirabegron and mirabegron combined with other medications for lower urinary tract symptoms. Our results showed that mirabegron was safe and effective in reducing the symptoms of overactive bladder."

Journal • Benign Prostatic Hyperplasia • 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

Mirabegron exhibits antibacterial and Immunomodulatory activities demonstrated by in vitro and in vivo studies. (PubMed, Sci Rep) - "According to our findings, in vitro and in vivo tests of mirabegron revealed possible antibacterial activity as well as immunomodulatory properties. Mirabegron could alleviate symptomatic UTIs."

Journal • Preclinical • Benign Prostatic Hyperplasia • Infectious Disease • Nephrology • Overactive Bladder • IFNG

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

Effectiveness and Safety of Mirabek Sustained-release 50 mg Tablets in Korean Patients with Overactive Bladder: A Multicenter Observational Study at Tertiary General Hospitals. (PubMed, Eur Urol Open Sci) - "Mirabegron, a first-in-class β3-adrenergic agonist, is a key therapy for overactive bladder (OAB)...We found that Mirabek improved bladder symptoms such as urgency and frequent urination over 6 mo, with very few side effects. Most patients stayed on the treatment and reported feeling better, suggesting that this affordable medication can help more people manage their OAB effectively."

Journal • Observational data • Overactive Bladder

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

β-1 Adrenoceptor is Responsible for the Apamin-Sensitive Small Conductance Ca2+-Activated K+ Current Activation in Female Rabbit Ventricles (AHA 2025) - "At 200ms PCL, β1 but not β2 or β3 AR activation accelerates Ca2+ release and IKAS activation in female, but not male rabbit ventricles."

Preclinical

Eco-friendly spectrofluorimetric determination of mirabegron in human plasma and tablets: greenness and blueness assessment. (PubMed, BMC Chem) - "The environmental sustainability of the proposed method was systematically evaluated through AGREE (Analytical Greenness Metric) and BAGI (Blue Applicability Grade Index) assessments, demonstrating superior eco-friendliness compared to conventional HPLC and electroanalytical techniques (AGREE score: 0.72 vs. 0.55-0.62). In addition to confirmation of the environmentally safety of the proposed approach, its blueness has been assessed using Blue Applicability Grade Index."

Journal

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

Overactive bladder medications and risk of emergency hospital admissions with delirium in adults without dementia: self-controlled case series. (PubMed, Age Ageing) - "We observed increased hospital admission rates with delirium for adults without dementia whilst prescribed OAB anticholinergics, but not whilst prescribed mirabegron. Delirium risk remained raised for longer for men and was greater in older men. Alternative management options for OAB in older people should be considered before prescribing anticholinergic medications."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Overactive Bladder

Transcutaneous tibial nerve stimulation combined mirabegron therapy significantly improves benign prostatic hyperplasia and overactive bladder: a prospective randomized controlled trial. (PubMed, Am J Transl Res) - "Combined TTNS and mirabegron therapy significantly improved BPH and OAB symptoms and enhanced quality of life, without increasing adverse effects compared to mirabegron monotherapy."

Journal • Benign Prostatic Hyperplasia • Overactive Bladder

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

Mirabegron treatment reduces myofibroblasts and CXCR2 expression in adipose tissue in obesity. (PubMed, Mol Med) - No abstract available

Journal • Genetic Disorders • Immunology • Obesity • CXCR2

A Retrospective Database Analysis of Anticholinergic Burden Among Older Patients With and Without Overactive Bladder in South Korea. (PubMed, Int Neurourol J) - "In patients with OAB, 100-day cumulative anticholinergic cognitive burden score was 15 times higher than in patients without OAB, due to anticholinergic medications. In this study, mirabegron did not contribute to anticholinergic burden. As there are unwanted effects associated with this burden, clinicians should consider the anticholinergic burden of each patient when using pharmacotherapy to treat OAB."

Journal • Retrospective data • Overactive Bladder

A Prospective Paired Comparison Trial of Mirabegron and Anticholinergics in Patients With Low Bladder Compliance. (PubMed, Int Neurourol J) - "A β3-adrenoceptor agonist, mirabegron, was more effective than anticholinergics in improving BC. Among the two components of improved BC-increased bladder volume and reduced detrusor filling pressure-the β3-adrenoceptor agonist showed a more pronounced effect on lowering detrusor filling pressure, compared to anticholinergics. These findings suggest that β3-adrenoceptor agonists might play an important role in reducing the tension of the bladder wall by controlling detrusor muscle tone, and this may be an important target for future research."

Compliance • Journal