Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic applications of mirabegron across urological conditions—such as overactive bladder syndrome, neurogenic detrusor overactivity, and pediatric urinary incontinence—alongside metabolic indications including obesity and prediabetes. Sponsored by pharmaceutical developers like Astellas Pharma as well as academic medical centers, these studies also evaluate pharmacokinetic profiles. Recruitment statuses across this body of research encompass actively recruiting, completed, active not recruiting, terminated, and withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07187466 | NOT_YET_RECRUITING | Overactive Bladder; Parkinson Disease |
VA Office of Research and Development |
2026-10-01 | PHASE4 |
| NCT05713799 | NOT_YET_RECRUITING | Insulin Resistance; Obesity |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2026-09-09 | PHASE2 |
| NCT07310797 | RECRUITING | Ureteral Calculi |
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
2026-02-13 | PHASE4 |
| NCT07114640 | NOT_YET_RECRUITING | Urinary Bladder, Overactive |
Far Eastern Memorial Hospital |
2025-08-07 | PHASE3 |
| NCT07566208 | NOT_YET_RECRUITING | Ventricular Arrhythmias and Cardiac Arrest |
Cedars-Sinai Medical Center |
2026-05 | PHASE2 |
| NCT07585513 | NOT_YET_RECRUITING | Postural Orthostatic Tachycardia Syndrome (POTS) |
Cedars-Sinai Medical Center |
2026-05 | PHASE2 |
| NCT06791460 | RECRUITING | Ovarian Cancer Recurrent |
Obstetrics & Gynecology Hospital of Fudan University |
2025-03-18 | PHASE2; PHASE3 |
| NCT06465576 | ACTIVE_NOT_RECRUITING | Urinary Incontinence in Children |
University of Aarhus |
2024-05-27 | PHASE4 |
| NCT07261683 | RECRUITING | Ovarian Cancer; Immunotherapy; Pembrolizumab |
Obstetrics & Gynecology Hospital of Fudan University |
2025-12 | PHASE2 |
| NCT06551246 | RECRUITING | Urinary Incontinence in Children |
University of Aarhus |
2024-06-27 | PHASE3 |
| NCT07711808 | NOT_YET_RECRUITING | Overactive Bladder (OAB) |
Universidade do Porto |
2026-07 | PHASE4 |
| NCT04666636 | RECRUITING | PreDiabetes |
Philip Kern |
2020-12-07 | PHASE2 |
| NCT05362292 | RECRUITING | Urinary Incontinence, Urge; Urinary Incontinence; Overactive Bladder; Incontinence, Urge; Incontinence, Urinary; Incontinence |
University of California, San Francisco |
2022-10-04 | PHASE4 |
| NCT05051436 | RECRUITING | Pre-diabetes; Obesity |
Philip Kern |
2021-12-13 | PHASE4 |
| NCT05221021 | RECRUITING | Overactive Bladder Syndrome |
Walter Reed National Military Medical Center |
2022-10-01 | PHASE4 |
| NCT07398261 | ACTIVE_NOT_RECRUITING | Treatment of Non-monosymptomatic Nocturnal Enuresis |
Menoufia University |
2023-08-28 | PHASE3 |
| NCT05806164 | ACTIVE_NOT_RECRUITING | Urgency Urinary Incontinence |
Women and Infants Hospital of Rhode Island |
2023-06-06 | PHASE4 |
| NCT03049462 | COMPLETED | Polycystic Ovary Syndrome |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2017-03-13 | PHASE1 |
| NCT05369351 | RECRUITING | Intracerebral Haemorrhage |
Tianjin Medical University General Hospital |
2024-01-17 | PHASE2 |
| NCT06534762 | RECRUITING | NSCLC; SCLC; Colorectal Cancer; Pancreas Cancer; TNBC - Triple-Negative Breast Cancer; DLBCL - Diffuse Large B Cell Lymphoma; Squamous Cell Carcinoma of Head and Neck |
Zhejiang Provincial People's Hospital |
2024-07-15 | PHASE2 |
| NCT05968885 | RECRUITING | Urinary Bladder, Overactive; Urodynamics; Effect of Drug |
Mackay Memorial Hospital |
2021-10-01 | PHASE4 |
| NCT05604222 | ACTIVE_NOT_RECRUITING | Urgency Urinary Incontinence; Nocturia |
Shachi Tyagi |
2023-03-05 | PHASE4 |
| NCT06479720 | RECRUITING | Effect of Drug; Urinary Bladder, Overactive |
Mackay Memorial Hospital |
2022-06-16 | PHASE4 |
| NCT06197295 | RECRUITING | Urinary Bladder, Overactive; Effect of Drug |
Mackay Memorial Hospital |
2022-06-16 | PHASE4 |
| NCT07025642 | RECRUITING | Overactive Bladder (OAB) |
Mackay Medical College |
2025-07-01 | |
| NCT05621616 | ACTIVE_NOT_RECRUITING | Neurogenic Detrusor Overactivity |
Astellas Pharma Global Development, Inc. |
2024-02-28 | PHASE3 |
| NCT07259148 | ACTIVE_NOT_RECRUITING | Urgency Urinary Incontinence |
Emilio José Dávila Álvarez |
2025-11-22 | |
| NCT05880862 | COMPLETED | Urinary Bladder, Overactive; Urinary Incontinence; Accidental Falls |
The University of Texas Medical Branch, Galveston |
2023-09-28 | EARLY_PHASE1 |
| NCT07668232 | COMPLETED | Posterior Urethral Valve |
South Valley University |
2025-01-01 | |
| NCT07199894 | RECRUITING | Nocturnal Enuresis in Children |
Mansoura University |
2024-12-01 | PHASE3 |
| NCT06803030 | RECRUITING | Ureteral Stent-Related Symptom |
Bir Hospital |
2025-08-30 | PHASE3 |
| NCT07017439 | NOT_YET_RECRUITING | Benign Prostate Hypertrophy(BPH) |
University of Manitoba |
2025-08 | PHASE3 |
| NCT07307261 | COMPLETED | Ureteric Stent-related Morbidity |
Avraiem Talaat |
2024-10-10 | |
| NCT05634174 | ACTIVE_NOT_RECRUITING | Obesity, Prediabetes |
University of California, San Diego |
2023-08-01 | PHASE1 |
| NCT07533565 | COMPLETED | Cirrhosis; Asthma |
Kafrelsheikh University |
2024-07-01 | PHASE4 |
| NCT06133075 | COMPLETED | Postural Orthostatic Tachycardia Syndrome; Chronic Orthostatic Intolerance; Syncope |
Cedars-Sinai Medical Center |
2023-12-22 | PHASE2 |
| NCT06181591 | UNKNOWN | Overactive Bladder |
Seoul National University Hospital |
2024-04-01 | PHASE2 |
| NCT04023253 | UNKNOWN | Overactive Bladder Syndrome |
Far Eastern Memorial Hospital |
2019-08-01 | PHASE3 |
| NCT03251300 | UNKNOWN | Overactive Bladder Syndrome |
Far Eastern Memorial Hospital |
2017-08-01 | PHASE4 |
| NCT05946902 | UNKNOWN | Female Patients With Overactive Bladder Syndrome |
Far Eastern Memorial Hospital |
2023-09-12 | PHASE4 |
| NCT05990387 | COMPLETED | Resting Energy Expenditure; Thermogenesis; Brown Adipose Tissue |
Indiana University |
2023-07-19 | PHASE1; PHASE2 |
| NCT05621616 | Recruiting | Neurogenic Detrusor Overactivity |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2024-02-28 | Phase 3 |
| NCT06011265 | COMPLETED | Thermoregulation |
Christopher Bell |
2023-04-27 | EARLY_PHASE1 |
| NCT05779514 | UNKNOWN | Tumour |
Zhejiang Provincial People's Hospital |
2022-08-18 | |
| NCT05992428 | COMPLETED | Healthy |
Dong-A ST Co., Ltd. |
2023-08-22 | PHASE1 |
| NCT05188742 | UNKNOWN | Overactive Bladder Syndrome |
Taipei Veterans General Hospital, Taiwan |
2021-11-10 | PHASE4 |
| NCT05617664 | UNKNOWN | Nocturnal Enuresis |
Benha University |
2022-11-23 | |
| NCT05452434 | UNKNOWN | Overactive Bladder |
Peking Union Medical College Hospital |
2022-07-15 | PHASE4 |
| NCT04641975 | TERMINATED | Overactive Bladder (OAB); Pharmacokinetics of Mirabegron |
Astellas Pharma Global Development, Inc. |
2021-03-15 | PHASE3 |
| NCT04766021 | COMPLETED | Resting Energy Expenditure; Thermogenesis; Brown Adipose Tissue |
Indiana University |
2021-11-30 | PHASE1; PHASE2 |
| NCT06123364 | COMPLETED | Overactive Bladder; Overactive Bladder Syndrome |
Serdinsek Tamara |
2019-10-14 | |
| NCT04907032 | COMPLETED | Overactive Bladder |
University of Alabama at Birmingham |
2021-10-01 | PHASE4 |
| NCT06181019 | UNKNOWN | Overactive Bladder |
The Affiliated Ganzhou Hospital of Nanchang University |
2021-12-01 | PHASE1 |
| NCT05745584 | UNKNOWN | Patients With Low Bladder Compliance of 20ml/H2O or Less Despite Taking Anticholinergics |
Yonsei University |
2016-01-12 | |
| NCT05490082 | UNKNOWN | Voiding Disorders |
Mansoura University |
2022-03-01 | PHASE3 |
| NCT07447518 | COMPLETED | Lower Urinary Tract Symptoms |
Kafrelsheikh University |
2022-09-22 | EARLY_PHASE1 |
| NCT01950520 | COMPLETED | Healthy Volunteers |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2014-02-07 | PHASE2 |
| NCT06184334 | COMPLETED | Overactive Bladder |
Elsayed Abdelhalim Elsayed |
2022-09-14 | |
| NCT02279615 | UNKNOWN | Overactive Bladder; Benign Prostatic Hyperplasia |
St. Joseph's Healthcare Hamilton |
2021-12 | PHASE4 |
| NCT06124066 | COMPLETED | Ureteral Stone; Kidney Stones; Ureteral Stenosis |
Hasanuddin University |
2022-07-01 | PHASE4 |
| NCT04909255 | UNKNOWN | Sjogren's Syndrome; Overactive Bladder Syndrome |
China Medical University Hospital |
2021-03-23 | PHASE4 |
| NCT05767632 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2022-05-30 | PHASE1 |
| NCT04325880 | UNKNOWN | Ureteral Stent; Stent Related Symptoms |
Mansoura University |
2021-12-01 | PHASE3 |
| NCT04420533 | COMPLETED | Urinary Bladder, Overactive; Sexual Behavior; Sexual Activity; Behavior Therapy; Sexual Function Disturbances |
Chang Gung Memorial Hospital |
2020-06-05 | |
| NCT04823442 | COMPLETED | Type 2 Diabetes |
Université de Sherbrooke |
2021-01-21 | |
| NCT04562090 | COMPLETED | Urge Incontinence; Overactive Bladder (OAB) |
Astellas Pharma China, Inc. |
2021-01-06 | PHASE4 |
| NCT02893553 | COMPLETED | Spinal Cord Injury; Autonomic Dysreflexia; Baroreceptor Integrity; Sympathetic Integrity; Vagal Integrity; Autonomic Integrity; Hypotensive; Cognitive Function; Cerebral Blood Flow; Blood Pressure |
James J. Peters Veterans Affairs Medical Center |
2016-12 | PHASE2 |
| NCT03187795 | UNKNOWN | Spinal Cord Injuries; Urinary Bladder, Neurogenic |
Kessler Foundation |
2019-04-03 | PHASE2 |
| NCT05040984 | Recruiting | Overactive Bladder Syndrome |
Far Eastern Memorial Hospital |
2021-04-30 | -- |
| NCT04641975 | Terminated | Overactive Bladder (OAB)|Pharmacokinetics of Mirabegron |
Astellas Pharma Global Development Inc.|Astellas Pharma Inc |
2021-03-15 | Phase 3 |
| NCT04693897 | Unknown status | Overactive Bladder Syndrome|Detrusor Overactivity |
Chang Gung Memorial Hospital |
2021-03-01 | -- |
| NCT04286152 | UNKNOWN | Nephrolithiasis |
Unity Health Toronto |
2020-02-03 | PHASE3 |
| NCT02599480 | COMPLETED | Hypertrophy, Left Ventricular |
Jean-Luc Balligand |
2016-09-12 | PHASE2 |
| NCT03926754 | COMPLETED | Heart Failure With Reduced Ejection Fraction NYHA Class III-IV |
Henning Bundgaard |
2017-01-23 | PHASE2; PHASE3 |
| NCT04501640 | COMPLETED | Pharmacokinetics of Mirabegron; Food Effect; Healthy Chinese Subjects |
Astellas Pharma China, Inc. |
2020-09-21 | PHASE4 |
| NCT02540707 | COMPLETED | Overactive Bladder Syndrome |
National Taiwan University Hospital |
2015-09-08 | PHASE4 |
| NCT03612401 | COMPLETED | Spinal Cord Injuries; Neurogenic Bladder; Cognitive Change |
The University of Texas Health Science Center at San Antonio |
2018-12-05 | EARLY_PHASE1 |
| NCT04476966 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2020-01-20 | PHASE1 |
| NCT02916693 | COMPLETED | Erectile Dysfunction; Overactive Bladder; Urinary Incontinence |
Johns Hopkins University |
2017-08-01 | PHASE1; PHASE2 |
| NCT03600766 | UNKNOWN | BPH; Erectile Dysfunction; Prostate Hyperplasia; Erectile Abnormalities; Prostatic Neoplasms |
Mansoura University |
2018-08-01 | PHASE2 |
| NCT03411252 | TERMINATED | Achalasia |
Thomas Jefferson University |
2018-02-15 | EARLY_PHASE1 |
| NCT02744430 | COMPLETED | Ureteral Obstruction; Flank Pain |
Baylor College of Medicine |
2017-07-22 | PHASE2 |
| NCT03632772 | UNKNOWN | Overactive Bladder Syndrome |
Buddhist Tzu Chi General Hospital |
2018-08-01 | PHASE2 |
| NCT02787083 | TERMINATED | Cystitis, Interstitial |
Philadelphia Urosurgical Associates |
2016-08 | PHASE3 |
| NCT02086188 | COMPLETED | Multiple Sclerosis |
Theodore R. Brown, MD MPH |
2014-05 | PHASE4 |
| NCT02919176 | COMPLETED | Obese; Metabolic Syndrome |
Philip Kern |
2016-09-01 | EARLY_PHASE1 |
| NCT03044912 | UNKNOWN | Overactive Bladder Syndrome |
Buddhist Tzu Chi General Hospital |
2015-11-16 | PHASE3 |
| NCT02462837 | TERMINATED | Urinary Bladder, Overactive; Pain; Lower Urinary Tract Symptoms |
Southern Illinois University |
2015-05 | PHASE2 |
| NCT02495389 | COMPLETED | Overactive Bladder |
Loyola University |
2015-01-28 | PHASE4 |
| NCT03695822 | WITHDRAWN | Overactive Bladder Syndrome |
Far Eastern Memorial Hospital |
2018-12-24 | PHASE4 |
| NCT02751931 | COMPLETED | Neurogenic Detrusor Overactivity |
Astellas Pharma Europe B.V. |
2016-06-17 | PHASE3 |
| NCT02757768 | COMPLETED | Benign Prostatic Hyperplasia; Overactive Bladder |
Astellas Pharma Global Development, Inc. |
2016-06-13 | PHASE4 |
| NCT02536976 | COMPLETED | Parkinson Disease; Overactive Bladder; Impaired Cognition |
HealthPartners Institute |
2015-12 | PHASE4 |
| NCT03412513 | UNKNOWN | Overactive Bladder; Parkinson Disease |
Seoul National University Hospital |
2017-07-17 | PHASE4 |
| NCT03087578 | WITHDRAWN | Overactive Bladder |
University Hospitals Cleveland Medical Center |
2017-07-01 | |
| NCT02092181 | COMPLETED | Parkinsons Disease |
Daniel Burdick, MD |
2014-03 | PHASE4 |
| NCT02981459 | WITHDRAWN | Urinary Frequency/Urgency; Bladder Irritable; Bladder Pain Syndrome |
State University of New York at Buffalo |
2017-12-08 | PHASE4 |
| NCT02811289 | COMPLETED | Type 2 Diabetes |
Université de Sherbrooke |
2016-08-05 | |
| NCT02095665 | COMPLETED | Nephrolithiasis |
Nova Scotia Health Authority |
2014-01-01 | PHASE4 |
| NCT02044510 | TERMINATED | Urinary Bladder, Neurogenic |
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
2014-07 | PHASE2; PHASE3 |
| NCT03536494 | COMPLETED | Overactive Bladder Syndrome |
Catalan Institute of Health |
2017-01-01 | |
| NCT03558919 | COMPLETED | Overactive Bladder |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2017-01-01 | PHASE4 |
| NCT02436889 | COMPLETED | Urge Incontinence; Urinary Incontinence, Urge |
University of California, San Francisco |
2016-02 | PHASE4 |
| NCT02216214 | COMPLETED | Overactive Bladder (OAB) |
Astellas Pharma Global Development, Inc. |
2014-10-07 | PHASE4 |
| NCT02468375 | COMPLETED | Overactive Bladder |
Samsung Medical Center |
2015-06 | PHASE4 |
| NCT02354807 | UNKNOWN | Brown Fat |
Otto Muzik |
2015-10 | PHASE2 |
| NCT03106623 | COMPLETED | Overactive Bladder |
Ono Pharmaceutical Co., Ltd. |
2017-04-07 | PHASE2 |
| NCT02656173 | COMPLETED | Overactive Bladder |
Astellas Pharma Inc |
2016-01-25 | PHASE4 |
| NCT03012113 | UNKNOWN | Obesity |
Ingrid Jazet |
2016-06 | PHASE4 |
| NCT02775539 | UNKNOWN | Pulmonary Hypertension; Mirabegron; Heart Failure; Pulmonary Vascular Resistance Abnormality |
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III |
2016-06 | PHASE2 |
| NCT02311569 | COMPLETED | Myeloproliferative Neoplasm; Primary Myelofibrosis; Essential Thrombocythemia; Polycythemia Vera |
Swiss Cancer Institute |
2015-04 | PHASE2 |
| NCT02526979 | COMPLETED | Overactive Bladder; Neurogenic Detrusor Overactivity |
Astellas Pharma Europe B.V. |
2015-12-17 | PHASE1 |
| NCT02045862 | COMPLETED | Urinary Bladder Overactive; Overactive Bladder; Urgency Incontinence; Urinary Bladder Diseases\Urologic Diseases |
Astellas Pharma Europe B.V. |
2014-03-17 | PHASE3 |
| NCT02294396 | COMPLETED | Overactive Bladder (OAB) |
Astellas Pharma Inc |
2014-10-28 | PHASE4 |
| NCT03059134 | COMPLETED | Urinary Incontinence; Overactive Bladder Syndrome |
Buddhist Tzu Chi General Hospital |
2015-04-28 | PHASE3 |
| NCT02476175 | COMPLETED | Overactive Bladder; Urinary Incontinence |
CHU de Quebec-Universite Laval |
2013-04 | PHASE3 |
| NCT02468830 | COMPLETED | Overactive Bladder; Urinary Incontinence |
CHU de Quebec-Universite Laval |
2013-04 | PHASE3 |
| NCT02361502 | UNKNOWN | Overactive Bladder |
Seoul National University Hospital |
2015-02 | PHASE4 |
| NCT02138747 | COMPLETED | Overactive Bladder (OAB) |
Astellas Pharma Global Development, Inc. |
2014-07-24 | PHASE4 |
| NCT01972841 | COMPLETED | Urinary Bladder Overactive; Urinary Bladder Diseases\Urologic Diseases; Overactive Bladder; Urgency Incontinence |
Astellas Pharma Europe B.V. |
2013-11-05 | PHASE3 |
| NCT01876433 | COMPLETED | Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) |
Henning Bundgaard |
2013-09-30 | PHASE2 |
| NCT02211846 | COMPLETED | Neurogenic Detrusor Overactivity; Overactive Bladder; Pharmacokinetics of Mirabegron |
Astellas Pharma Inc |
2014-09-21 | PHASE1 |
| NCT01908829 | COMPLETED | Urinary Bladder Diseases; Urinary Bladder Overactive; Urologic Diseases |
Astellas Pharma Europe Ltd. |
2013-07-10 | PHASE3 |
| NCT02169713 | COMPLETED | Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction (DDI) |
Astellas Pharma Europe B.V. |
2014-05 | PHASE1 |
| NCT02127034 | COMPLETED | Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction (DDI) |
Astellas Pharma Europe B.V. |
2014-03 | PHASE1 |
| NCT01964183 | COMPLETED | Pharmacokinetics of Mirabegron and Tolterodine; Healthy |
Astellas Pharma Inc |
2013-06 | PHASE4 |
| NCT01745094 | COMPLETED | Overactive Bladder |
Astellas Pharma Inc |
2012-10-01 | PHASE4 |
| NCT01638000 | COMPLETED | Urologic Diseases; Urinary Bladder, Overactive; Urinary Bladder Diseases |
Astellas Pharma Europe Ltd. |
2012-06-12 | PHASE3 |
| NCT02010944 | COMPLETED | Phase 1; Bioavailability; Healthy Subjects |
Astellas Pharma Europe B.V. |
2012-09 | PHASE1 |
| NCT01747564 | COMPLETED | Healthy Subjects; Plasma Concentration of Mirabegron |
Astellas Pharma Inc |
2012-08 | PHASE1 |
| NCT01720212 | COMPLETED | Healthy Chinese Volunteers |
Astellas Pharma China, Inc. |
2012-05 | PHASE1 |
| NCT01340027 | COMPLETED | Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Signs and Symptoms; Urinary Bladder, Overactive |
Astellas Pharma Europe B.V. |
2011-03-29 | PHASE2 |
| NCT01334905 | COMPLETED | Healthy Volunteer; Pharmacokinetics of YM178 |
Astellas Pharma Inc |
2011-03 | PHASE1 |
| NCT01489696 | COMPLETED | Cardiovascular; Healthy Subjects; Pharmacokinetics |
Astellas Pharma Inc |
2010-08 | PHASE1 |
| NCT01284309 | COMPLETED | Intraocular Pressure |
Astellas Pharma Inc |
2010-11 | PHASE1 |
| NCT01199523 | COMPLETED | Healthy Subjects |
Astellas Pharma Inc |
2010-05 | PHASE1 |
| NCT00688688 | COMPLETED | Urinary Bladder, Overactive |
Astellas Pharma Inc |
2008-04-25 | PHASE3 |
| NCT00912964 | COMPLETED | Urinary Bladder, Overactive |
Astellas Pharma Inc |
2009-04-28 | PHASE3 |
| NCT01285596 | COMPLETED | Healthy Volunteers; Pharmacokinetics of Mirabegron |
Astellas Pharma Inc |
2009-03 | PHASE1 |
| NCT01284868 | COMPLETED | Healthy Volunteers; Pharmacodynamics of Mirabegron |
Astellas Pharma Inc |
2009-07 | PHASE1 |
| NCT00940121 | COMPLETED | Healthy; Pharmacokinetics of Mirabegron |
Astellas Pharma Inc |
2009-04-30 | PHASE1 |
| NCT01297192 | COMPLETED | Healthy Volunteers; Pharmacokinetics of Mirabegron |
Astellas Pharma Inc |
2009-03 | PHASE1 |
| NCT00939757 | COMPLETED | Healthy; Pharmacokinetics of Mirabegron |
Astellas Pharma Inc |
2009-05 | PHASE1 |
| NCT00662909 | COMPLETED | Urinary Bladder, Overactive |
Astellas Pharma Inc |
2008-03-28 | PHASE3 |
| NCT01579461 | COMPLETED | Pharmacokinetics; Healthy Subjects; Mild and Moderate Hepatic Impairment |
Astellas Pharma Europe B.V. |
2008-11 | PHASE1 |
| NCT00689104 | COMPLETED | Urinary Bladder, Overactive |
Astellas Pharma Inc |
2008-04-28 | PHASE3 |
| NCT01297179 | COMPLETED | Healthy Volunteers; Pharmacokinetics of Mirabegron |
Astellas Pharma Inc |
2008-10 | PHASE1 |
| NCT01478568 | COMPLETED | Pharmacokinetics of Mirabegron; Healthy Subjects |
Astellas Pharma Inc |
2008-10 | PHASE1 |
| NCT00776516 | COMPLETED | Pharmacokinetics of YM178 |
Astellas Pharma Inc |
2008-10 | PHASE1 |
| NCT00410514 | COMPLETED | Lower Urinary Tract Symptoms; Bladder Outlet Obstruction |
Astellas Pharma Inc |
2006-12 | PHASE2 |
| NCT01478529 | COMPLETED | Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects |
Astellas Pharma Inc |
2006-02 | PHASE1 |
| NCT01478503 | COMPLETED | Pharmacokinetics; Healthy Subjects |
Astellas Pharma Inc |
2005-05 | PHASE1 |
| NCT01478490 | COMPLETED | Pharmacokinetics of Mirabegron; Healthy Subjects |
Astellas Pharma Inc |
2002-09 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-22)
Check the
Mirabegron
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.