Drugs / Mirabegron
Mirabegron
also known as
YM178 · Mybetriq · Myrbetriq · Betanis · Betmiga · mirabegron OCAS · mirabegron, which is Myrbetriq (TM) by Astellas Pharma · Mirbetriq · +1 more
Other / unclassified targets ADRB3 via activation
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed disorder of neck of urinary bladder 1 milestone | |||||
| Filed | US (FDA) | — | disorder of neck of urinary bladder | 2021-01-06 | “FDA accepted priority review for its New Drug Application (NDA) for mirabegron for oral suspension” astellas.com ↗ “accepted for filing the New Drug Application for mirabegron (generic name / code name: YM178)” astellas.com ↗ “submitted new drug applications for mirabegron in the U.S. and Europe in August 2011.” astellas.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (2) | US (FDA) | MYRBETRIQ | — | 2018-04-27 – 2021-03-25 | fda.gov ↗ |
| Approved | EU (EMA) | Betmiga | — | 2012-12-20 | europa.eu ↗ |
| Approved | US (FDA) | MYRBETRIQ | — | 2012-06-28 | fda.gov ↗ |
| Filed | EU (EMA) | — | — | — | “submitted new drug applications for mirabegron in the U.S. and Europe in August 2011.” astellas.com ↗ |
Trials 122 · started per year
today
US approved 2012
EU approved 2012
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06011265 | Apr 2023 → Jan 2024 | — | Christopher Bell | Completed | No outcome recorded |
| Phase 0 | NCT03612401 | Dec 2018 → Mar 2020 | spinal cord injury | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 0 | NCT03411252 | Feb 2018 → Dec 2019 | achalasia | Thomas Jefferson University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 133 trials · 1 met primary | ||||||
| Phase 1 | NCT05992428 | Aug → Nov 2023 | — | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05634174 | Aug 2023 → Sep 2025 overdue | prediabetes syndrome | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03049462 | Mar 2017 → Aug 2026 | polycystic ovary syndrome | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 1 | NCT02526979 | Dec 2015 → Sep 2016 | overactive bladder | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02211846 | Sep 2014 → Sep 2015 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02169713 | May → Aug 2014 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02127034 | Mar → Jun 2014 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02010944 | Sep → Nov 2012 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01747564 | Aug → Oct 2012 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01720212 | May → Aug 2012 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01334905 | Mar → Jun 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01284309 | Nov 2010 → Feb 2011 | — | Astellas Pharma Inc | Completed | Met primary |
| Phase 1 | NCT01489696 | Aug 2010 → Feb 2011 | cardiovascular disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01199523 | May → Nov 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00965926 | Jul → Sep 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01284868 | Jul → Nov 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00939757 | May → Jul 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00940121 | Apr → Jul 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01285596 | Mar → Nov 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01297192 | Mar → Jul 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01579461 | Nov 2008 → Apr 2009 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01478568 | Oct 2008 → Jan 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01297179 | Oct 2008 → Mar 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00776516 | Oct → Dec 2008 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01663961 | Sep → Dec 2008 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT00856570 | Sep → Dec 2008 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00750620 | Sep 2008 → Sep 2009 | impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01476800 | Jul → Nov 2006 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01478529 | Feb → Mar 2006 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01478503 | May → Oct 2005 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01646294 | Jan → May 2005 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01651312 | Jan → Feb 2003 | metabolic disease | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01478490 | Sep → Nov 2002 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05990387 | Jul 2023 → Apr 2024 | — | Indiana University | Completed | No outcome recorded |
| Phase 1/2 | NCT05240456 | Feb → Jul 2022 | overactive bladder | Mansoura University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04766021 | Nov 2021 → Apr 2023 | — | Indiana University | Completed | No outcome recorded |
| Phase 1/2 | NCT02916693 | Aug 2017 → Jan 2020 | erectile dysfunction, overactive bladder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 220 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT05713799 | Oct 2026 → Mar 2030 expected | obesity disorder | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07566208 | May 2026 → May 2028 expected | ventricular tachycardia | Cedars-Sinai Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07585513 | May 2026 → May 2028 expected | postural orthostatic tachycardia syndrome | Cedars-Sinai Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06534762 | Jul 2024 → Jul 2026 overdue | colorectal cancer, diffuse large B-cell lymphoma, head and neck squamous cell carcinoma, malignant pancreatic neoplasm +3 | Zhejiang Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06181591 | Apr 2024 → Apr 2025 | overactive bladder | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05369351 | Jan 2024 → Aug 2026 overdue | intracerebral hemorrhage | Tianjin Medical University General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04666636 | Dec 2020 → Jun 2027 expected | prediabetes syndrome | Philip Kern | Recruiting | No outcome recorded |
| Phase 2 | NCT03187795 | Apr 2019 → Sep 2021 | spinal cord injury, urinary bladder disorder | Kessler Foundation | Unknown | No outcome recorded |
| Phase 2 | NCT03632772 | Aug 2018 → Jul 2019 | overactive bladder | Buddhist Tzu Chi General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02893553 | Dec 2016 → Dec 2021 | autonomic dysreflexia, cognitive disorder, hypotensive disorder, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02354807 | Oct 2015 → Oct 2017 | hibernoma | Otto Muzik | Unknown | No outcome recorded |
| Phase 2 | NCT02462837 | May 2015 → Jan 2019 | overactive bladder | Southern Illinois University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02311569 | Apr 2015 → Dec 2016 | acquired polycythemia vera, essential thrombocythemia, primary myelofibrosis | Swiss Cancer Institute | Completed | Missed primary |
| Phase 2 | NCT01950520 | Feb 2014 → Dec 2022 | — | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT01783470 | Feb 2013 → Oct 2014 | obesity disorder | Aaron Cypess | Completed | Met primary |
| Phase 2 | NCT01340027 | Mar 2011 → Jun 2012 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 2 | NCT00527033 | Sep 2007 → Apr 2008 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT00410514 | Dec 2006 → Aug 2008 | urinary tract obstruction | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT01604928 | Apr 2004 → Jan 2005 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 2 | NCT00337090 | ? → Mar 2007 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06791460 | Mar 2025 → Feb 2028 expected | ovarian carcinoma | Obstetrics & Gynecology Hospital of Fudan University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02044510 | Jul 2014 → Jan 2018 | urinary bladder disorder | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Terminated | No outcome recorded Stop: Enrollment |
| Phase 324 trials · 6 met primary · 2 missed | ||||||
| Phase 3 | NCT07017439 | Aug → Dec 2025 overdue | benign prostatic hyperplasia | University of Manitoba | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07199894 | Dec 2024 → Dec 2025 overdue | nocturnal enuresis | Mansoura University | Recruiting | No outcome recorded |
| Phase 3 | NCT06551246 | Jun 2024 → Oct 2027 expected | enuresis | University of Aarhus | Recruiting | No outcome recorded |
| Phase 3 | NCT05621616 | Feb 2024 → Feb 2026 | overactive bladder | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04641975 | Mar 2021 → Jul 2023 | overactive bladder | Astellas Pharma Global Development, Inc. | Terminated | Missed primary |
| Phase 3 | NCT04286152 | Feb 2020 → Feb 2021 | nephrolithiasis | Unity Health Toronto | Unknown | No outcome recorded |
| Phase 3 | NCT04023253 | Aug 2019 → Dec 2024 | overactive bladder | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02787083 | Aug 2016 → Jul 2019 | interstitial cystitis | Philadelphia Urosurgical Associates | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02751931 | Jun 2016 → Nov 2018 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT03044912 | Nov 2015 → Feb 2019 | overactive bladder | Buddhist Tzu Chi General Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03059134 | Apr 2015 → Apr 2016 | overactive bladder | Buddhist Tzu Chi General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02045862 | Mar 2014 → Sep 2016 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT01972841 | Nov 2013 → Oct 2015 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Mixed |
| Phase 3 | NCT01908829 | Jul 2013 → Nov 2014 | overactive bladder | Astellas Pharma Europe Ltd. | Completed | Met primary |
| Phase 3 | NCT02476175 | Apr 2013 → Apr 2016 | overactive bladder | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 3 | NCT02468830 | Apr 2013 → Jan 2016 | overactive bladder | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 3 | NCT01638000 | Jun 2012 → Apr 2013 | overactive bladder | Astellas Pharma Europe Ltd. | Completed | Missed primary |
| Phase 3 | NCT01043666 | Dec 2009 → Sep 2011 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00966004 | Jul 2009 → Feb 2010 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00912964 | Apr 2009 → Apr 2010 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00840645 | Dec 2008 → Mar 2010 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00689104 | Apr 2008 → Mar 2009 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00688688 | Apr 2008 → May 2010 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00662909 | Mar 2008 → Apr 2009 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 430 trials · 4 met primary · 1 missed | ||||||
| Phase 4 | NCT07310797 | Feb 2026 → Dec 2029 expected | ureterolithiasis | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Recruiting | No outcome recorded |
| Phase 4 | NCT06465576 | May 2024 → Dec 2027 expected | enuresis | University of Aarhus | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05946902 | Sep 2023 → Jul 2024 | overactive bladder | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05604222 | Mar 2023 → Jun 2026 overdue | overactive bladder | University of Pittsburgh | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05452434 | Jul 2022 → Jul 2023 | overactive bladder | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05051436 | Dec 2021 → Jan 2027 expected | obesity disorder, prediabetes syndrome | Philip Kern | Recruiting | No outcome recorded |
| Phase 4 | NCT05188742 | Nov 2021 → Sep 2023 | overactive bladder | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT05968885 | Oct 2021 → Jun 2026 overdue | overactive bladder | Mackay Memorial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04907032 | Oct 2021 → Apr 2023 | overactive bladder | University of Alabama at Birmingham | Completed | Met primary |
| Phase 4 | NCT04909255 | Mar 2021 → Aug 2022 | Sjogren syndrome, overactive bladder | China Medical University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04562090 | Jan 2021 → Mar 2022 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT04501640 | Sep → Oct 2020 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT03695822 | Dec 2018 → Jan 2019 | overactive bladder | Far Eastern Memorial Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT02981459 | Dec 2017 → Jun 2018 | urinary bladder disorder | State University of New York at Buffalo | Withdrawn | No outcome recorded |
| Phase 4 | NCT03251300 | Aug 2017 → Dec 2024 | overactive bladder | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03558919 | Jan → Dec 2017 | overactive bladder | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT02757768 | Jun 2016 → Aug 2018 | benign prostatic hyperplasia, overactive bladder | Astellas Pharma Global Development, Inc. | Completed | Met primary |
| Phase 4 | NCT02436889 | Feb 2016 → Dec 2017 | overactive bladder | University of California, San Francisco | Completed | Missed primary |
| Phase 4 | NCT02656173 | Jan 2016 → Jul 2017 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 4 | NCT02536976 | Dec 2015 → Aug 2018 | Parkinson disease, cognitive disorder, overactive bladder | HealthPartners Institute | Completed | No outcome recorded |
| Phase 4 | NCT02540707 | Sep 2015 → Aug 2020 | overactive bladder | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02468375 | Jun 2015 → Oct 2017 | overactive bladder | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02361502 | Feb 2015 → Jan 2016 | overactive bladder | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02495389 | Jan 2015 → Jan 2019 | overactive bladder | Loyola University | Completed | No outcome recorded |
| Phase 4 | NCT02216214 | Oct 2014 → Nov 2017 | overactive bladder | Astellas Pharma Global Development, Inc. | Completed | Met primary |
| Phase 4 | NCT02138747 | Jul 2014 → Oct 2015 | overactive bladder | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02086188 | May 2014 → Apr 2019 | multiple sclerosis | Theodore R. Brown, MD MPH | Completed | No outcome recorded |
| Phase 4 | NCT02095665 | Jan 2014 → Mar 2018 | nephrolithiasis | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 4 | NCT01964183 | Jun → Aug 2013 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01745094 | Oct 2012 → Jul 2013 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07025642 | Jul 2025 → May 2026 overdue | overactive bladder | Mackay Medical College | Recruiting | No outcome recorded |
| — | NCT05779514 | Aug 2022 → Dec 2023 | neoplasm | Zhejiang Provincial People's Hospital | Unknown | No outcome recorded |
| — | NCT04823442 | Jan 2021 → Apr 2022 | type 2 diabetes mellitus | University of Sherbrooke | Completed | No outcome recorded |
| — | NCT04420533 | Jun 2020 → May 2022 | overactive bladder, sexual disorder | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| — | NCT02811289 | Aug 2016 → May 2018 | type 2 diabetes mellitus | University of Sherbrooke | Completed | No outcome recorded |
| — | NCT05745584 | Jan 2016 → Mar 2023 | low compliance bladder | Yonsei University | Unknown | No outcome recorded |
| Comparator or background therapy43 trials | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 0 | NCT05880862 Comparator | Sep 2023 → Dec 2025 | overactive bladder | The University of Texas Medical Branch, Galveston | Completed | No outcome recorded |
| Phase 0 | NCT07447518 Comparator | Sep 2022 → Jan 2023 | — | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 0 | NCT02919176 Comparator | Sep 2016 → Feb 2019 | metabolic syndrome X, obesity disorder | Philip Kern | Completed | No outcome recorded |
| Phase 1 | NCT06181019 Comparator | Dec 2021 → Mar 2023 | overactive bladder | The Affiliated Ganzhou Hospital of Nanchang University | Unknown | No outcome recorded |
| Phase 2 | NCT07261683 Background | Dec 2025 → Nov 2027 expected | ovarian cancer | Obstetrics & Gynecology Hospital of Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06133075 Comparator | Dec 2023 → May 2025 | orthostatic hypotension, postural orthostatic tachycardia syndrome | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03600766 Comparator | Aug 2018 → Jan 2020 | benign prostatic hyperplasia, erectile dysfunction, prostate neoplasm | Mansoura University | Unknown | No outcome recorded |
| Phase 2 | NCT02744430 Comparator | Jul 2017 → Oct 2019 | ureteral obstruction | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT03106623 Comparator | Apr → Aug 2017 | overactive bladder | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02599480 Comparator | Sep 2016 → Feb 2021 | heart disorder | Catholic University of Louvain | Completed | No outcome recorded |
| Phase 2 | NCT02775539 Comparator | Jun 2016 → Jan 2017 | heart failure, pulmonary hypertension | National Center for Cardiovascular Research Carlos III | Unknown | No outcome recorded |
| Phase 2 | NCT01876433 Comparator | Sep 2013 → Sep 2015 | heart failure | Henning Bundgaard | Completed | No outcome recorded |
| Phase 2/3 | NCT03926754 Comparator | Jan 2017 → Jan 2021 | advanced heart failure | Henning Bundgaard | Completed | No outcome recorded |
| Phase 3 | NCT06803030 Comparator | Aug → Dec 2025 overdue | — | Bir Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT07114640 Comparator | Aug 2025 → Dec 2028 expected | overactive bladder | Far Eastern Memorial Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07398261 Comparator | Nov 2023 → Nov 2026 expected | nocturnal enuresis | Menoufia University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05658874 Background | Dec 2022 → Dec 2024 | interstitial cystitis, levator syndrome | Jocelyn Fitzgerald | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05490082 Comparator | Mar 2022 → Mar 2023 | urinary bladder disorder | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT04325880 Comparator | Dec 2021 → Jun 2022 | ureteral disorder | Mansoura University | Unknown | No outcome recorded |
| Phase 4 | NCT07187466 Comparator | Jul 2026 → Mar 2030 expected | Parkinson disease, overactive bladder | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07711808 Comparator | Jul 2026 → Jul 2027 expected | overactive bladder | University of Porto | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07533565 Comparator | Jul 2024 → Jul 2025 | asthma, cirrhosis of liver | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 4 | NCT05806164 Comparator | Jun 2023 → Aug 2026 overdue | overactive bladder | Women and Infants Hospital of Rhode Island | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07829029 Comparator | Oct 2022 → May 2027 expected | — | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05362292 Comparator | Oct 2022 → May 2027 expected | overactive bladder | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05221021 Comparator | Oct 2022 → Dec 2026 expected | overactive bladder | Walter Reed National Military Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06124066 Comparator | Jul → Sep 2022 | nephrolithiasis, stricture or kinking of ureter, ureterolithiasis | Hasanuddin University | Completed | No outcome recorded |
| Phase 4 | NCT06197295 Comparator | Jun 2022 → Jun 2026 overdue | overactive bladder | Mackay Memorial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06479720 Comparator | Jun 2022 → Jun 2026 overdue | overactive bladder | Mackay Memorial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT02279615 Comparator | Dec 2021 → Dec 2022 | benign prostatic hyperplasia, overactive bladder | St. Joseph's Healthcare Hamilton | Unknown | No outcome recorded |
| Phase 4 | NCT03817931 Comparator | Aug 2019 → Feb 2022 | dementia, overactive bladder | Baylor Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT03412513 Comparator | Jul 2017 → Jul 2018 | Parkinson disease, overactive bladder | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03012113 Comparator | Jun 2016 → Jun 2017 | obesity disorder | Ingrid Jazet | Unknown | No outcome recorded |
| Phase 4 | NCT02294396 Background | Oct 2014 → Sep 2016 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02092181 Comparator | Mar 2014 → Jul 2018 | Parkinson disease | Daniel Burdick, MD | Completed | No outcome recorded |
| — | NCT07259148 Comparator | Nov 2025 → Jan 2026 overdue | overactive bladder | Emilio José Dávila Álvarez | Active not recruiting | No outcome recorded |
| — | NCT07668232 Comparator | Jan → Dec 2025 | posterior urethral valve | South Valley University | Completed | No outcome recorded |
| — | NCT07307261 Comparator | Oct 2024 → Oct 2025 | — | Avraiem Talaat | Completed | No outcome recorded |
| — | NCT05617664 Comparator | Nov 2022 → Sep 2023 | nocturnal enuresis | Benha University | Unknown | No outcome recorded |
| — | NCT06184334 Comparator | Sep → Dec 2022 | overactive bladder | Elsayed Abdelhalim Elsayed | Completed | No outcome recorded |
| — | NCT06123364 Comparator | Oct 2019 → Apr 2023 | overactive bladder | Serdinsek Tamara | Completed | No outcome recorded |
| — | NCT03087578 Comparator | Jul 2017 → Jul 2018 | overactive bladder | University Hospitals Cleveland Medical Center | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-09-04 | Lupin Limited | Regulatory Lupin Launches Mirabegron Extended-Release Tablets in the United States lupin.com ↗
Mumbai, Naples, September 04, 2024: Global pharma major Lupin Limited (Lupin) today announced the launch of Mirabegron Extended-Release Tablets, 50 mg, in the United States, after having received an approval from the United States Food and Drug Administration (U.S. FDA). |
| 2022-10-03 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA and 180 days shared exclusivity for Mirabegron Extended-Release Tablets zyduslife.com ↗
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq®). |
| 2022-09-29 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Mirabegron Extended-Release Tablets lupin.com ↗
it has received approval from the United States Food and Drug Administration (FDA) |
| 2021-03-26 | Astellas Pharma Inc | Regulatory Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO) astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules (mirabegron for extended-release oral suspension) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older. |
| 2021-01-06 | Astellas Pharma Inc | Regulatory FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients astellas.com ↗ |
| 2019-06-27 | Lupin Limited | Regulatory Lupin receives tentative U.S. FDA approval for Mirabegron ER Tablets lupin.com ↗
Lupin Limited (Lupin) announced that it has received tentative approval for its Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg, from the United States Food and Drug Administration (FDA), to market a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas). |
| 2019-04-02 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Mirabegron Extended-Release Tablets zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Mirabegron Extended-Release Tablets (US RLD- Myrbetriq® Extended-Release Tablets), 25 mg and 50 mg. |
| 2018-05-24 | Astellas Pharma Inc | Results Addition of Mirabegron to Tamsulosin Demonstrates Superior Efficacy Compared to Placebo in Men with Overactive Bladder Symptoms astellas.com ↗
In the study, the addition of mirabegron was well-tolerated and demonstrated superior improvement in quality of life (QoL). |
| 2018-05-08 | Astellas Pharma Inc | Regulatory FDA Approves Supplemental New Drug Application for Myrbetriq® (mirabegron) for Use in Combination with solifenacin succinate for the Treatment of Overactive Bladder Symptoms astellas.com ↗
FDA Approves Supplemental New Drug Application for Myrbetriq® (mirabegron) for Use in Combination with solifenacin succinate for the Treatment of Overactive Bladder Symptoms |
| 2017-09-13 | Astellas Pharma Inc | Regulatory U.S. FDA Accepts for Review Astellas’ Supplemental New Drug Application for mirabegron for Use in Combination with solifenacin succinate 5 mg for the Treatment of Overactive Bladder astellas.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) |
| 2017-06-30 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application for mirabegron for Use in Combination with solifenacin succinate 5 mg for the Treatment of Overactive Bladder astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. |
| 2013-01-11 | Astellas Pharma Inc | Regulatory NEW CLASS OF TREATMENT FOR OVERACTIVE BLADDER APPROVED IN EUROPE astellas.com ↗
A new treatment, BETMIGATM (mirabegron) has received approval from the European Commission (EC) for the treatment of overactive bladder (OAB) symptoms in adults. |
| 2011-11-11 | Astellas Pharma Inc | Regulatory Receipt of Filing Communication Letter from U.S. FDA Regarding Mirabegron (YM178) astellas.com ↗
Astellas Pharma Inc . (Tokyo: 4503, “Astellas”) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) indicating that it accepted for filing the New Drug Application for mirabegron (generic name / code name: YM178) and initiated a substantive review. |
| 2011-07-01 | Astellas Pharma Inc | Regulatory Approval for Betanis® tablet, a Treatment for OAB, in Japan astellas.com ↗
Betanis® tablet (generic name:mirabegron) was granted a Japanese marketing approval for the indication of urgency, urinary frequency, and urge urinary incontinence associated with overactive bladder (OAB*) on July 1, 2011. |
All press releases naming this drug 22 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 168 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mirabegron | “Here we determined the ability of 200 mg oral mirabegron (Myrbetriq, Astellas Pharma, Inc.), a β3-AR agonist currently approved to treat overactive bladder, to stimulate BAT as...” PMID 25565203 ↗ Jan 2015149“Mirabegron (Myrbetriq®, extended-release tablet, Astellas Pharma), is a medication approved by the Food and Drug Administration for the treatment of overactive bladder.” NCT06011265 ↗ “About 100 patients will receive Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults” NCT07307261 ↗ “The beta 3 agonist ,Mirabegron, has been shown to be effective for the treatment of OAB in adults through relaxation of bladder wall, with few side effects.” NCT05240456 ↗ “Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers” NCT01720212 ↗ “Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)” NCT05658874 ↗ “Mirabegron 25 mg tablet orally once daily for 30 days” NCT03817931 ↗ “* Mirabegron Pain Control Medications” NCT07016451 ↗ “Solifenacin 5mg and Mirabegron 25mg” NCT06197295 ↗ |
| Known as | Betanis | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095212 ↗ |
| Known as | Betmiga | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095212 ↗ |
| Known as | mirabegron OCAS | “Drug: mirabegron OCAS” NCT01478529 ↗ |
| Known as | mirabegron, which is Myrbetriq (TM) by Astellas Pharma | “mirabegron, which is Myrbetriq (TM) by Astellas Pharma” NCT01783470 ↗ |
| Known as | Mirbetriq | “Mirbetriq (Mirabegron) (50mg) will be administered orally at time 0 to activate brown adipose tissue.” NCT02811289 ↗ |
| Known as | Mybetriq | “Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary...” NCT07829029 ↗1“Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary...” NCT05362292 ↗ |
| Known as | Myrbetriq | “Beta-3 agonists (Mirabegron/Myrbetriq)” NCT07017439 ↗1“Mirabegron 50 MG [Myrbetriq]” NCT03087578 ↗ |
| Known as | Myrbetriq granules | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095212 ↗ |
| Known as | YM178 | “A Phase 1, Open-Label, Drug Interaction Study to Evaluate the Effect of Repeat Doses of Rifampin on the Single-Dose Pharmacokinetics of Mirabegron (YM178)” NCT00776516 ↗18“The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy poor or extensive metabolizers for CYP2D6” NCT01478490 ↗ “mirabegron (YM178)” NCT01297192 ↗ |
| Action | Activate | “β3 -adrenoceptor agonist” PMID 26663687 ↗ Mar 2014 |
| Modality | Other / unclassified | “β3 -adrenoceptor agonist” PMID 26663687 ↗ Mar 2014 |
| Route | Oral | “Oral” NCT00527033 ↗ |
| Target | ADRB3 | “ADRB3 agonist” NCT05634174 ↗ |