Myrbetriq

(mirabegron)

ApprovedSmall molecule

Mirabegron is used to treat overactive bladder, helping to reduce urinary urgency, frequency, and leakage by relaxing the bladder muscle.[2] Myrbetriq is currently approved and in use across 27 indications[4].[1]

Myrbetriq is one of 516 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

136

Total Trials

Active Trials

515

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Left Ventricular HypertrophyApproved

Type 2 Diabetes MellitusActive, not recruiting

Benign Prostatic HyperplasiaCompleted

Parkinson DiseaseCompleted

Lower Urinary Tract SymptomCompleted

Kidney DiseaseApproved

PolyuriaActive, not recruiting

Prediabetes SyndromeApproved

Urinary UrgencyCompleted

Cardiovascular DiseasePreclinical

Active, not recruiting

Left Ventricular HypertrophyApproved

Approved

Type 2 Diabetes MellitusPreclinical

Active, not recruiting

Benign Prostatic HyperplasiaApproved

Completed

Parkinson DiseaseApproved

Completed

Lower Urinary Tract SymptomApproved

Completed

Kidney DiseaseApproved

Approved

PolyuriaApproved

Active, not recruiting

Prediabetes SyndromeApproved

Approved

Urinary UrgencyApproved

Completed

Showing 10 of 27 indications

Competition

Competitive Landscape

286 competitors in Advanced Solid Tumors

#DrugCompanyPhaseTrials

Myrbetriq

Astellas

Approved

1 2

Abraxane

Bristol-Myers Squibb

Phase 2

10 3

Ibrance

Pfizer

Phase 2

4 4

Tagrisso

AstraZeneca

Phase 2

3 5

Mektovi

Pfizer

Phase 2

3 6

Trodelvy

Gilead

Phase 2

1 7

PENPULIMAB KCQX

AAkeso

Phase 2

2 8

Navmi

SSummit Therapeutics

Phase 2

1 9

Standard Chemotherapy

Roche

Phase 2

1 10

BNT327

BioNTech

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Not yet recruiting

Age-Related Macular Degeneration

NCT07305298

Phase 3Recruiting

Ureteral Stent-Related Symptom

NCT06803030

Q1 2027

ApprovedRecruiting

Prediabetes

NCT05051436

Post-ApprovalRecruiting

Overactive Bladder

NCT05221021

ApprovedActive, not recruiting

Urgency Urinary Incontinence

NCT05604222

Q2 2027

ApprovedRecruiting

Nocturia

NCT07829029

Clinical

Trials by Indication[1]

Overactive Bladder45 trials

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT01972841·3,527 enrolled

Sequencing and Combination of Mirabegron and TTNS in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT05188742·180 enrolled

Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder

Unknown status·—·Phase 4·NCT04909255·50 enrolled

Show 42 more trials

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)

Completed· Astellas logo

Astellas·Phase 4·NCT02138747·376 enrolled

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 2·NCT01340027·1,307 enrolled

Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00688688·2,792 enrolled

A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)

Completed· Astellas logo

Astellas·Phase 4·NCT02656173·568 enrolled

A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00662909·2,149 enrolled

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

Completed· Astellas logo

Astellas··NCT03602508·5,589 enrolled

Cardiovascular Morbidity During Treatment of Overactive Bladder With B3 Agonists

Completed·KKarolinska Institutet··NCT02622555·221 enrolled

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

Completed· Astellas logo

Astellas·Phase 1·NCT02526979·9 enrolled

Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

Unknown status·FFar Eastern Memorial Hospital·Phase 4·NCT05946902·150 enrolled

A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

Completed· Astellas logo

Astellas·Phase 4·NCT04562090·249 enrolled

A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)

Completed·—·Phase 4·NCT02092181·30 enrolled

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Completed· Astellas logo

Astellas··NCT03572231·805 enrolled

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT02045862·1,829 enrolled

Mirabegron Combined With Behavioral Intervention for Overactive Bladder：a Prospective Multicenter Randomized Controlled Clinical Study

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT05452434·600 enrolled

Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

Unknown status·—·Phase 3·NCT03044912·574 enrolled

MIrabegron With oveRACtive bLadder Symptoms in mEn

Unknown status·SSeoul National University Hospital·Phase 4·NCT02361502·462 enrolled

Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Unknown status·FFar Eastern Memorial Hospital·Phase 3·NCT04023253·120 enrolled

A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

Completed· Astellas logo

Astellas·Phase 4·NCT01745094·223 enrolled

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder

Completed· Astellas logo

Astellas·Phase 1·NCT02211846·34 enrolled

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

Completed· Astellas logo

Astellas·Phase 3·NCT01638000·1,887 enrolled

A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)

Terminated· Astellas logo

Astellas·Phase 3·NCT04641975·26 enrolled

Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease

Unknown status·SSeoul National University Hospital·Phase 4·NCT03412513·144 enrolled

A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

Completed· Astellas logo

Astellas··NCT02386072·1,524 enrolled

Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome

Unknown status·FFar Eastern Memorial Hospital··NCT05040984·500 enrolled

Efficacy and Safety of the Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder

Completed·—·Phase 4·NCT03558919·81 enrolled

Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker

Unknown status·—··NCT04693897·400 enrolled

Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

Completed·—·Phase 3·NCT03059134·168 enrolled

Prospective Study for Patient Perception of Treatment Satisfaction After Switching to Mirabegron in Patients With Overactive Bladder Who Were Unsatisfied With Efficacy of Antimuscarinic Therapy or Adverse Event.

Completed·SSamsung Medical Center·Phase 4·NCT02468375·434 enrolled

Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP

Unknown status·—·Phase 2·NCT03632772·130 enrolled

Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

Completed· Astellas logo

Astellas·Phase 4·NCT02294396·649 enrolled

A Trial Evaluating the Clinical Efficacy and Safety of Hibero SR (Mirabegron) 50 mg and Ditropan (Oxybutynin Chloride) 10 mg in Children Between 5 and 18 Years With Overactive Bladder (OAB)

Not yet recruiting·SSeoul National University Hospital·Phase 2·NCT06181591·44 enrolled

Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome

Withdrawn·FFar Eastern Memorial Hospital·Phase 4·NCT03695822

Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder

Completed·SSerdinsek Tamara·N/A·NCT06123364·56 enrolled

The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial

Not yet recruiting·FFar Eastern Memorial Hospital·Phase 3·NCT07114640·220 enrolled

Comparison of Electroacupuncture to Mirabegron for Treatment of Overactive Bladder

Withdrawn·UUniversity Hospitals Cleveland Medical Center·N/A·NCT03087578

Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome

Recruiting·WWalter Reed National Military Medical Center·Phase 4·NCT05221021·152 enrolled

Pilot Study of Mirabegron in Pediatric Patients With Overactive Bladder

Completed·—·Phase 3·NCT02468830·58 enrolled

Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00689104·2,336 enrolled

Add-on Mirabegron in Pediatric Patients With Refractory Overactive Bladder

Completed·—·Phase 3·NCT02476175·35 enrolled

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Completed· Astellas logo

Astellas·Phase 4·NCT02216214·888 enrolled

A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00912964·2,030 enrolled

Sequential Multiple Assignment Randomized Trial to Treat Urinary Symptoms in Parkinson Disease

Not yet recruiting·VVA Office of Research and Development·Approved·NCT07187466·146 enrolled

Concentration5 trials

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02169713·20 enrolled

Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine

Completed· Astellas logo

Astellas·Phase 4·NCT01964183·24 enrolled

To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females

Completed· Astellas logo

Astellas·Phase 1·NCT01478503·96 enrolled

Show 2 more trials

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02127034·26 enrolled

To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol

Completed· Astellas logo

Astellas·Phase 1·NCT01478490·28 enrolled

Heart Failure3 trials

Beta 3 Agonist Treatment in Heart Failure-2

Completed·HHenning Bundgaard·Phase 2/3·NCT03926754·56 enrolled

Assessment of Efficacy of Mirabegron, a New beta3-adrenergic Receptor in the Prevention of Heart Failure

Completed·JJean-Luc Balligand·Phase 2·NCT02599480·296 enrolled

Beta 3 Agonist Treatment in Heart Failure

Completed·HHenning Bundgaard·Phase 2·NCT01876433·70 enrolled

Function3 trials

Mirabegron and Physiological Function in Cold Environments

Completed·IIndiana University·Phase 1/2·NCT04766021·30 enrolled

MIrabegron and Physiological Function in Cold Environments

Completed·IIndiana University·Phase 1/2·NCT05990387·17 enrolled

Impact of Mirabegron on Erectile Function in BPH Patients

Unknown status·KKasr El Aini Hospital··NCT04503850·100 enrolled

ISS3 trials

Mirabegron and Brown Adipose Tissue

Unknown status·IIngrid Jazet·Phase 4·NCT03012113·20 enrolled

Effect of Mirabegron on Promoting Brown Adipose Tissue Activation

Unknown status·ZZhejiang Provincial People's Hospital·N/A·NCT05779514·20 enrolled

ADRB3 Signaling Pathway in Human Adipose Tissue

Active, not recruiting·UUniversity of California, San Diego·Phase 1·NCT05634174·40 enrolled

54 more indications

Treatment3 trials

Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

Withdrawn·SState University of New York at Buffalo·Phase 4·NCT02981459

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Completed· Astellas logo

Astellas·Phase 3·NCT01908829·2,174 enrolled

Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms

Unknown status·MMansoura University·Phase 3·NCT04325880·240 enrolled

Overactive Bladder (OAB)3 trials

Predictive Capacity of Baseline Neutrophil-to-Lymphocyte Ratio, Platelet-to-Lymphocyte Ratio, and Systemic Immune-Inflammation Index for Mirabegron Treatment Response in Women With Overactive Bladder: A Prospective Cohort Study

Recruiting·BBagcilar Training and Research Hospital··NCT07773532·115 enrolled

Evaluation of the Effects of Antimuscarinic Drugs on Ejaculation Duration and Refractory Period in Male Patients Treated for Overactive Bladder: An Observational Study

Completed·BBaşakşehir Çam & Sakura City Hospital··NCT07736560·40 enrolled

BURDEN AND EFFICACY OF ANTICHOLINERGIC VS MIRABEGRON IN OVERACTIVE BLADDER - A RANDOMIZED CONTROLLED STUDY

Not yet recruiting·UUniversidade do Porto·Approved·NCT07711808·208 enrolled

Spinal Cord Injury2 trials

Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury

Unknown status·KKessler Foundation·Phase 2·NCT03187795·62 enrolled

The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury

Completed·JJames J. Peters Veterans Affairs Medical Center·Phase 2·NCT02893553·21 enrolled

Urinary incontinence2 trials

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)

Recruiting·UUniversity of Aarhus·Phase 3·NCT06551246·236 enrolled

Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

Recruiting·UUniversity of Aarhus·Phase 4·NCT06465576·216 enrolled

Female2 trials

A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females

Completed· Astellas logo

Astellas·Phase 1·NCT01199523·352 enrolled

Management of OAB in Female Patients .

Completed·EElsayed Abdelhalim Elsayed·N/A·NCT06184334·300 enrolled

Erectile Dysfunction2 trials

Mirabegron For Erectile Dysfunction

Completed·JJohns Hopkins University·Phase 1/2·NCT02916693·20 enrolled

Mirabegron for Treatment of Erectile Dysfunction in Patients With LUTS Secondry to BPH: A Randomized Study

Unknown status·MMansoura University·Phase 2·NCT03600766·50 enrolled

Benign Prostatic Hyperplasia2 trials

Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.

Unknown status·SSt. Joseph's Healthcare Hamilton·Phase 4·NCT02279615·200 enrolled

A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Completed· Astellas logo

Astellas·Phase 4·NCT02757768·715 enrolled

Tics2 trials

A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously

Completed· Astellas logo

Astellas·Phase 1·NCT01297192·41 enrolled

Study of the Effect of Food on the Pharmacokinetics of Mirabegron

Completed· Astellas logo

Astellas·Phase 1·NCT00939757·76 enrolled

Lower Urinary Tract Symptom2 trials

Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)

Completed·SSouthern Illinois University··NCT02410135·34 enrolled

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

Completed· Astellas logo

Astellas·Phase 2·NCT00410514·200 enrolled

Cardiovascular2 trials

A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.

Completed· Astellas logo

Astellas·Phase 1·NCT01284868·12 enrolled

A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

Completed· Astellas logo

Astellas·Phase 1·NCT01489696·48 enrolled

Neurogenic bladder2 trials

Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT03612401·20 enrolled

Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients

Terminated·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 2/3·NCT02044510·32 enrolled

Trial2 trials

Mirabegron And Ureteral Stent-related Pain (MAP) Trial

Unknown status·UUnity Health Toronto·Phase 3·NCT04286152·142 enrolled

Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Completed·NNova Scotia Health Authority·Phase 4·NCT02095665·22 enrolled

Neurogenic Detrusor Overactivity2 trials

Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

Completed· Astellas logo

Astellas·Phase 3·NCT02751931·91 enrolled

A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children From 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity

Completed· Astellas logo

Astellas·Phase 3·NCT05621616·7 enrolled

PreDiabetes2 trials

The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Recruiting·PPhilip Kern·Approved·NCT05051436·96 enrolled

Mechanisms for Activation of Beige Adipose Tissue in Humans

Recruiting·PPhilip Kern·Phase 2·NCT04666636·65 enrolled

Cardiovascular Disease1 trial

Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease

Completed· Astellas logo

Astellas··NCT02570035·316 enrolled

Intravenous1 trial

Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron

Completed· Astellas logo

Astellas·Phase 1·NCT00940121·91 enrolled

Efficacy1 trial

Efficacy of Pharmacological Stimulation of BAT and WAT in Lean and Obese Young Adults

Unknown status·OOtto Muzik·Phase 2·NCT02354807·20 enrolled

Moderate Hepatic Impairment1 trial

A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01579461·32 enrolled

Metabolism1 trial

Activation of Brown Adipose Tissue Metabolism Using Mirabegron

Completed·UUniversité de Sherbrooke·N/A·NCT04823442·9 enrolled

Drug1 trial

Specified Drug Use-results Survey of Betanis Tablets

Completed· Astellas logo

Astellas··NCT01898624·300 enrolled

Pain1 trial

Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain

Completed·—·Phase 2·NCT02744430·33 enrolled

Memory1 trial

Treatment of Incontinence Without Memory Problems

Completed·UUniversity of California, San Francisco·Phase 4·NCT02436889·23 enrolled

Urinary urgency1 trial

Mirabegron and Urinary Urgency Incontinence

Completed·LLoyola University·Phase 4·NCT02495389·84 enrolled

Pulmonary Hypertension1 trial

Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure

Unknown status·FFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III·Phase 2·NCT02775539·80 enrolled

Double J Stent1 trial

Double j Stent Related Symptoms

Completed·KKafrelsheikh University·Phase 1·NCT07447518·535 enrolled

Myeloproliferative Neoplasms1 trial

Sympathicomimetic Agonist in Patients With Myeloproliferative Neoplasms With JAK2-mutation

Completed·SSwiss Cancer Institute·Phase 2·NCT02311569·39 enrolled

Ureteral Stent Placement1 trial

Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement

Terminated·SSouthern Illinois University·Phase 2·NCT02462837·11 enrolled

Parkinson disease1 trial

Mirabegron in Parkinson Disease and Impaired Cognition

Completed·HHealthPartners Institute·Phase 4·NCT02536976·7 enrolled

Interstitial Cystitis1 trial

A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis

Terminated·PPhiladelphia Urosurgical Associates·Phase 3·NCT02787083·9 enrolled

Medication1 trial

A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels

Completed· Astellas logo

Astellas·Phase 1·NCT02010944·72 enrolled

Achalasia1 trial

Mirabegron in Achalasia: A Clinical and Manometric Proof of Concept Pilot Study

Terminated·TThomas Jefferson University·Phase 1·NCT03411252·5 enrolled

Ureteral Stent-Related Symptom1 trial

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

Recruiting·—·Phase 3·NCT06803030·189 enrolled

Age-Related Macular Degeneration1 trial

Mirabegron in Patients With Age-Related Macular Degeneration

Not yet recruiting·UUniversity of Naples··NCT07305298·312 enrolled

Sex1 trial

Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms

Completed·—·N/A·NCT04420533·150 enrolled

Shivering1 trial

Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01950520·47 enrolled

Drug Interactions1 trial

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

Completed·DDong-A ST Co., Ltd.·Phase 1·NCT05992428·37 enrolled

Refractory1 trial

Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT04907032·54 enrolled

Enuresis1 trial

Mirabegron 25 mg for Treatment of Primary Nocturnal Enuresis

Unknown status·—·N/A·NCT05617664·150 enrolled

Interaction1 trial

Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers

Completed· Astellas logo

Astellas·Phase 1·NCT00776516·24 enrolled

Age1 trial

A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and Sex

Completed· Astellas logo

Astellas·Phase 1·NCT01285596·75 enrolled

ART1 trial

A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

Completed· Astellas logo

Astellas·Phase 4·NCT04501640·24 enrolled

Multiple Sclerosis1 trial

Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis

Completed·—·Phase 4·NCT02086188·28 enrolled

Intraocular Pressure1 trial

A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01284309·321 enrolled

Advanced Solid Tumors1 trial

Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study

Recruiting·ZZhejiang Provincial People's Hospital·Phase 2·NCT06534762·260 enrolled

Arterial Stiffness1 trial

Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes

Completed·NNational Taiwan University Hospital·Phase 4·NCT02540707·113 enrolled

Insulin resistance1 trial

Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity

Not yet recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT05713799·60 enrolled

Treatment of Non-monosymptomatic Nocturnal Enuresis1 trial

Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children

Active, not recruiting·MMenoufia University·Phase 3·NCT07398261·151 enrolled

Ureteral Calculi1 trial

A Randomized Controlled Trial Comparing Mirabegron and Tamsulosin for Ureteral Stone Expulsion and Clinical Symptom Improvement

Recruiting·TTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation·Approved·NCT07310797·500 enrolled

Nocturia1 trial

Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH Trial

Recruiting·UUniversity of California, San Francisco·Approved·NCT07829029·270 enrolled

Polycystic Ovary Syndrome1 trial

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 1·NCT03049462·55 enrolled

Urgency Urinary Incontinence1 trial

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

Active, not recruiting·SShachi Tyagi·Approved·NCT05604222·120 enrolled

Posterior Urethral Valve1 trial

Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation: A Comparative Prospective Randomized Study

Completed·SSouth Valley University·Preclinical·NCT07668232·52 enrolled

Urinary Bladder, Overactive1 trial

Comparative Effectiveness of Pelvic Floor Muscle Training, Mirabegron, and Trospium Among Older Women With Urgency Urinary Incontinence and High Fall Risk: a Feasibility Randomized Clinical Study

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT05880862·48 enrolled

Unspecified8 trials

To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together

Completed· Astellas logo

Astellas·Phase 1·NCT01478568·28 enrolled

TReating Incontinence for Underlying Mental and Physical Health

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT05362292·270 enrolled

Brown Fat Activation Study

Completed·PPhilip Kern·Phase 1·NCT02919176·39 enrolled

Show 5 more trials

A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill

Completed· Astellas logo

Astellas·Phase 1·NCT01297179·30 enrolled

Predictors for Retreatement of OAB After DC Mirabegron

Completed·NNational Taiwan University Hospital··NCT04550702·120 enrolled

THE EFFECTS OF MIRABEGRON AND TAMSULOSIN FOR PATIENTS WITH URETERAL STENTS

Completed·HHasanuddin University·Phase 4·NCT06124066·42 enrolled

Using Mirabegron to Increase BP in Patients With POTS

Completed·—·Phase 2·NCT06133075·20 enrolled

A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation

Completed· Astellas logo

Astellas·Phase 1·NCT01478529·12 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 28, 2012

MYRBETRIQ

NDA NDA202611

Jun 28, 2012

MYRBETRIQ

NDA NDA202611

Jul 19, 2013

MYRBETRIQ

NDA NDA202611

Mar 13, 2014

MYRBETRIQ

NDA NDA202611

Feb 9, 2015

MYRBETRIQ

NDA NDA202611

Aug 10, 2015

MYRBETRIQ

NDA NDA202611

Nov 2, 2015

MYRBETRIQ

NDA NDA202611

Aug 1, 2016

MYRBETRIQ

NDA NDA202611

Aug 16, 2016

MYRBETRIQ

NDA NDA202611

Jul 28, 2017

MYRBETRIQ

NDA NDA202611

Apr 27, 2018

MYRBETRIQ

NDA NDA202611

Mar 25, 2021

MYRBETRIQ

NDA NDA202611

Mar 25, 2021

MYRBETRIQ GRANULES

NDA NDA213801

Mar 25, 2021

MYRBETRIQ GRANULES

NDA NDA213801

Sources

References

[1]
ClinicalTrials.gov — 136 trial records for mirabegron. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Myrbetriq drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — mirabegron compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for mirabegron. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213801). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Myrbetriq. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-3 Adrenergic Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Astellas

Patent Landscape[6]

Patent Cliff

Oct 30, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8772315Oct 30, 2028

8772315*PEDApr 30, 2029

10842780Sep 28, 2029

11707451Sep 28, 2029

12097189Sep 28, 2029

7 more patents

12059409Sep 28, 2029

11707451*PEDMar 28, 2030

10842780*PEDMar 28, 2030

12059409*PEDMar 28, 2030

12097189*PEDMar 28, 2030

10058536Mar 31, 2036

10058536*PEDSep 30, 2036

Myrbetriq

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Overactive Bladder45 trials

Concentration5 trials

Heart Failure3 trials

Function3 trials

ISS3 trials

Treatment3 trials

Overactive Bladder (OAB)3 trials

Spinal Cord Injury2 trials

Urinary incontinence2 trials

Female2 trials

Erectile Dysfunction2 trials

Benign Prostatic Hyperplasia2 trials

Tics2 trials

Lower Urinary Tract Symptom2 trials

Cardiovascular2 trials

Neurogenic bladder2 trials

Trial2 trials

Neurogenic Detrusor Overactivity2 trials

PreDiabetes2 trials

Cardiovascular Disease1 trial

Intravenous1 trial

Efficacy1 trial

Moderate Hepatic Impairment1 trial

Metabolism1 trial

Drug1 trial

Pain1 trial

Memory1 trial

Urinary urgency1 trial

Pulmonary Hypertension1 trial

Double J Stent1 trial

Myeloproliferative Neoplasms1 trial

Ureteral Stent Placement1 trial

Parkinson disease1 trial

Interstitial Cystitis1 trial

Medication1 trial

Achalasia1 trial

Ureteral Stent-Related Symptom1 trial

Age-Related Macular Degeneration1 trial

Sex1 trial

Shivering1 trial

Drug Interactions1 trial

Refractory1 trial

Enuresis1 trial

Interaction1 trial

Age1 trial

ART1 trial

Multiple Sclerosis1 trial

Intraocular Pressure1 trial

Advanced Solid Tumors1 trial

Arterial Stiffness1 trial

Insulin resistance1 trial

Treatment of Non-monosymptomatic Nocturnal Enuresis1 trial

Ureteral Calculi1 trial

Nocturia1 trial

Polycystic Ovary Syndrome1 trial

Urgency Urinary Incontinence1 trial

Posterior Urethral Valve1 trial

Urinary Bladder, Overactive1 trial

Unspecified8 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News