Drugs / Solifenacin
Solifenacin
also known as
solifenacin succinate · VESIcare · NSC-759144 · Sofenacin · SOLI · solifenacin free base · Solifenacina · Solifenacine · +5 more
Small molecule targets CHRM2, CHRM3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed overactive bladder 1 milestone | |||||
| Filed | Japan (PMDA) | Vesicare | overactive bladder | 2009-12-22 | “announced that it submitted an application for market authorization for “orally disintegrating tablet YM905 (generic name: solifenacin succinate)“ to the Pharmaceuticals and...” astellas.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | VESICARE | — | 2004-11-19 | fda.gov ↗ |
Trials 91 · started per year
today
US approved 2004
1
4
4
6
8
6
13
6
11
5
5
2
5
2
2
1
1
4
1
3
20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT02494349 | Aug → Nov 2015 | benign prostatic hyperplasia, overactive bladder | Jeil Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02180997 | Jul 2014 → Mar 2015 | benign prostatic hyperplasia, overactive bladder | Jeil Pharmaceutical Co., Ltd. | 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 | NCT01539707 | Mar → Aug 2012 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01406158 | May → Jul 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01262391 | Oct 2010 → Aug 2011 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01953848 | Apr → Jul 2010 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01953861 | Apr → Jun 2010 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01953887 | Mar → Jul 2010 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01015040 | Sep → Nov 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01943487 | Aug → Dec 2009 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01297192 | Mar → Jul 2009 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT07617922 | May 2026 → Apr 2027 expected | ureterolithiasis | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 2 | NCT03632772 | Aug 2018 → Jul 2019 | overactive bladder | Buddhist Tzu Chi General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02860065 | Sep 2016 → Jun 2017 | Alzheimer disease | Chase Pharmaceuticals Corporation, an affiliate of Allergan plc | Withdrawn | No outcome recorded |
| Phase 2 | NCT02549196 | Oct 2015 → Sep 2017 | Alzheimer disease | Chase Pharmaceuticals Corporation, an affiliate of Allergan plc | Completed | No outcome recorded |
| Phase 2 | NCT01642277 | Jul 2012 → Jul 2014 | overactive bladder | Loyola University | Completed | No outcome recorded |
| Phase 2 | NCT01530373 | Feb 2012 → Jul 2027 expected | breast cancer | University of Arkansas | Recruiting | No outcome recorded |
| Phase 2 | NCT01340027 | Mar 2011 → Jun 2012 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 2 | NCT00507455 | Jun 2007 → Aug 2008 | urinary tract obstruction | Astellas Pharma Inc | Completed | Met primary |
| Phase 322 trials · 6 met primary | ||||||
| Phase 3 | NCT07429734 | Feb → Oct 2026 expected | overactive bladder | Mansoura University | 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 | NCT04023253 | Aug 2019 → Dec 2024 | overactive bladder | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02805452 | Jul 2016 → May 2017 | overactive bladder | Center Eugene Marquis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02972268 | Feb 2016 → Nov 2017 | benign prostatic hyperplasia | Jeil Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02827578 | Jan 2016 → Aug 2017 | benign prostatic hyperplasia | IlDong Pharmaceutical Co Ltd | Unknown | 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 | NCT01981954 | Sep 2013 → Dec 2015 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT01908829 | Jul 2013 → Nov 2014 | overactive bladder | Astellas Pharma Europe Ltd. | Completed | Met primary |
| Phase 3 | NCT01655069 | Oct 2012 → Oct 2014 | overactive bladder | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 3 | NCT01565694 | Aug 2012 → Apr 2016 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT01565707 | Jun 2012 → Dec 2013 | overactive bladder | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT01021332 | Apr 2010 → Dec 2011 | benign prostatic hyperplasia | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 3 | NCT00368706 | Sep 2006 → Mar 2008 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00463541 | Jun 2004 → Apr 2005 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00454740 | Jun 2004 → Aug 2005 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00454896 | May 2004 → Sep 2005 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00801944 | Apr 2004 → Oct 2005 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00802373 | Jul 2003 → Oct 2004 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00189800 | — | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 436 trials · 2 met primary · 5 missed | ||||||
| Phase 4 | NCT07711808 | Jul 2026 → Jul 2027 expected | overactive bladder | University of Porto | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06465576 | May 2024 → Dec 2027 expected | enuresis | University of Aarhus | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05968885 | Oct 2021 → Jun 2026 overdue | overactive bladder | Mackay Memorial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04090190 | Oct 2019 → May 2021 | overactive bladder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02294396 | Oct 2014 → Sep 2016 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01876186 | May 2013 → Dec 2015 | overactive bladder | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02094703 | Apr 2013 → Nov 2014 | urinary tract infection | Dr Cipto Mangunkusumo General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01747577 | Dec 2012 → Oct 2013 | benign prostatic hyperplasia, overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01559389 | Mar 2012 → Jun 2017 | overactive bladder | Loyola University | Completed | Missed primary |
| Phase 4 | NCT01314781 | Jan 2012 → Jan 2014 | overactive bladder | Cantonal Hospital, Frauenfeld | Completed | No outcome recorded |
| Phase 4 | NCT01457573 | Oct 2011 → Jul 2014 | — | Timothy Boone, MD, PhD | Completed | No outcome recorded |
| Phase 4 | NCT01833663 | Oct 2011 → Oct 2013 | overactive bladder | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01371994 | Aug 2011 → Oct 2013 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01505439 | Jun 2011 → Jun 2014 | female stress incontinence, overactive bladder | Jeong Gu Lee | Completed | No outcome recorded |
| Phase 4 | NCT01381120 | Oct 2010 → Jun 2012 | overactive bladder | Barrie Urology Associates | Completed | No outcome recorded |
| Phase 4 | NCT01126424 | Apr → Dec 2010 | — | Astellas Pharma Inc | Completed | Missed primary |
| Phase 4 | NCT01318837 | Apr 2010 → Sep 2011 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01092624 | Mar 2010 → Oct 2011 | pelvic organ prolapse | Hartford Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01093534 | Jan 2010 → Jun 2011 | overactive bladder | Astellas Pharma Inc | Completed | Missed primary |
| Phase 4 | NCT01018264 | Jan 2010 → Aug 2014 | overactive bladder | University of South Florida | Completed | Missed primary |
| Phase 4 | NCT02667470 | Sep 2009 → May 2013 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00979472 | Apr 2009 → Jun 2010 | overactive bladder | Asan Medical Center | Completed | Missed primary |
| Phase 4 | NCT00884104 | Mar 2009 → Dec 2010 | overactive bladder | KYU-SUNG LEE | Completed | No outcome recorded |
| Phase 4 | NCT00773552 | Nov 2008 → Apr 2009 | overactive bladder | Stamford Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT00771394 | Oct 2008 → Jan 2010 | benign prostatic hyperplasia, overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00759577 | Sep 2008 → May 2010 | overactive bladder | NYU Langone Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00699049 | Jun 2008 → Mar 2010 | overactive bladder | KYU-SUNG LEE | Completed | No outcome recorded |
| Phase 4 | NCT00629642 | Mar 2008 → Jan 2011 | multiple sclerosis, spinal cord disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00584090 | Nov 2007 → Apr 2011 | Parkinson disease | University of South Florida | Withdrawn | No outcome recorded |
| Phase 4 | NCT02715024 | Sep 2007 → Apr 2011 | benign prostatic hyperplasia, overactive bladder | Astellas Pharma Taiwan, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00573508 | Aug 2007 → Jul 2008 | overactive bladder | Astellas Pharma Inc | Completed | Met primary |
| Phase 4 | NCT00826527 | Jan 2007 → Dec 2009 | overactive bladder | Seattle Urology Research Center | Unknown | No outcome recorded |
| Phase 4 | NCT00909428 | Jan 2007 → Jul 2008 | overactive bladder | Loyola University | Completed | Met primary |
| Phase 4 | NCT00431041 | Dec 2006 → Feb 2008 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00337558 | May 2006 → May 2007 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00333112 | May 2006 → Jan 2007 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT07025642 | Jul 2025 → May 2026 overdue | overactive bladder | Mackay Medical College | Recruiting | No outcome recorded |
| — | NCT06489951 | Dec 2024 → Jun 2025 | overactive bladder | Xing Liu | Completed | No outcome recorded |
| — | NCT05911594 | Feb 2022 → Feb 2023 | — | Benha University | Completed | No outcome recorded |
| — | NCT04064619 | Jan 2018 → Aug 2019 | overactive bladder | Beni-Suef University | Completed | No outcome recorded |
| — | NCT04477265 | Jun 2016 → Dec 2021 | overactive bladder | Far Eastern Memorial Hospital | Completed | No outcome recorded |
| — | NCT01627145 | Aug 2012 → Jan 2015 | overactive bladder | National Taiwan University Hospital | Unknown | No outcome recorded |
| — | NCT01215721 | Oct 2010 → May 2013 | — | University of California, Irvine | Completed | No outcome recorded |
| — | NCT01499069 | Feb 2010 → Nov 2015 | overactive bladder | Samsung Medical Center | Completed | No outcome recorded |
| — | NCT01503580 | Aug 2008 → Jul 2010 | — | National Taiwan University Hospital | Completed | No outcome recorded |
| — | NCT00581061 | Jun 2008 → Feb 2009 | — | University of California, Irvine | Terminated | No outcome recorded |
| — | NCT00852696 | Feb 2008 → Jul 2009 | overactive bladder | Cleveland Clinic Florida | Terminated | No outcome recorded |
| Comparator or background therapy53 trials | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00832650 Comparator | Apr → Dec 2009 | — | Pfizer | Terminated | Missed primary |
| Phase 1 | NCT02634489 Comparator | Mar → Jul 2009 | benign prostatic hyperplasia | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1/2 | NCT05240456 Comparator | Feb → Jul 2022 | overactive bladder | Mansoura University | Unknown | No outcome recorded |
| Phase 1/2 | NCT01737411 Comparator | Jan 2013 → Dec 2017 | urinary bladder disorder | University Hospital of Cologne | Unknown | No outcome recorded |
| Phase 1/2 | NCT01737918 Comparator | Jan 2013 → Dec 2017 | disorder of neck of urinary bladder | University Hospital of Cologne | Unknown | No outcome recorded |
| Phase 2 | NCT03566134 Comparator | Jul 2018 → Dec 2019 | overactive bladder | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03106623 Comparator | Apr → Aug 2017 | overactive bladder | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00510406 Comparator | Jan → Sep 2007 | benign prostatic hyperplasia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2/3 | NCT01486706 Comparator | Oct 2010 → Oct 2014 | overactive bladder | Michael E. Chua | 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 | NCT05282069 Comparator | May 2022 → Nov 2023 | overactive bladder | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| 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 3 | NCT03149809 Comparator | Mar 2018 → Sep 2023 | Parkinson disease, overactive bladder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT01767519 Comparator | Mar 2013 → Sep 2014 | overactive bladder | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT01638000 Comparator | Jun 2012 → Apr 2013 | overactive bladder | Astellas Pharma Europe Ltd. | Completed | Missed primary |
| Phase 3 | NCT01166438 Comparator | Mar 2010 → May 2012 | overactive bladder | NICHD Pelvic Floor Disorders Network | Completed | Missed primary |
| Phase 3 | NCT00821184 Comparator | Sep 2006 → Sep 2008 | overactive bladder | Lahey Clinic | Terminated | No outcome recorded |
| Phase 4 | NCT07473310 Comparator | Nov 2025 → Jun 2027 expected | overactive bladder | Mansoura University | Recruiting | No outcome recorded |
| Phase 4 | NCT07416968 Comparator | Sep 2025 → Sep 2026 overdue | overactive bladder | Mansoura University | Recruiting | No outcome recorded |
| Phase 4 | NCT07114848 Comparator | Jun → Dec 2024 | ureterolithiasis | Liaquat National Hospital & Medical College | Completed | No outcome recorded |
| Phase 4 | NCT06479720 Comparator | Jun 2022 → Jun 2026 overdue | overactive bladder | Mackay Memorial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06197295 Background | Jun 2022 → Jun 2026 overdue | overactive bladder | Mackay Memorial Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05494567 Comparator | Nov 2021 → Aug 2022 | benign prostatic hyperplasia, overactive bladder | Mansoura University | Unknown | No outcome recorded |
| Phase 4 | NCT04819360 Comparator | Jun 2021 → Mar 2022 | multiple sclerosis, urinary bladder disorder | Brigitte Schürch | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04909255 Comparator | Mar 2021 → Aug 2022 | Sjogren syndrome, overactive bladder | China Medical University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03817931 Comparator | Aug 2019 → Feb 2022 | dementia, overactive bladder | Baylor Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT03468465 Comparator | May 2018 → Mar 2019 | overactive bladder | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Unknown | No outcome recorded |
| Phase 4 | NCT03038321 Comparator | Feb → Dec 2017 | cystitis, non-invasive bladder urothelial carcinoma | Mansoura University | Unknown | No outcome recorded |
| Phase 4 | NCT03558919 Comparator | Jan → Dec 2017 | overactive bladder | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT02540707 Comparator | Sep 2015 → Aug 2020 | overactive bladder | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01777217 Comparator | Feb 2013 → Jan 2014 | overactive bladder | Advanced Research Network | Terminated | No outcome recorded |
| Phase 4 | NCT01880619 Comparator | Jan 2013 → May 2014 | — | Mansoura University | Completed | No outcome recorded |
| Phase 4 | NCT01745094 Background | Oct 2012 → Jul 2013 | overactive bladder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT01423838 Comparator | Sep 2011 → Sep 2012 | overactive bladder | Adana Numune Training and Research Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01533597 Comparator | Dec 2010 → Dec 2013 | overactive bladder | Soonchunhyang University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00547378 Comparator | Oct 2007 → Aug 2016 | overactive bladder | MedtronicNeuro | Completed | No outcome recorded |
| — | NCT06201013 Comparator | Apr → Sep 2026 overdue | overactive bladder | Children's Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| — | NCT07312955 Comparator | May → Nov 2025 | overactive bladder | Ain Shams University | Completed | No outcome recorded |
| — | NCT06955533 Comparator | Apr → Aug 2024 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT05798403 Comparator | Jul 2023 → Aug 2025 overdue | overactive bladder | Yin Ping | Recruiting | No outcome recorded |
| — | NCT06024005 Comparator | Apr → May 2023 | overactive bladder | Ege University | Completed | No outcome recorded |
| — | NCT05709990 Comparator | Jan → Jun 2023 | overactive bladder | Xing Liu | Completed | No outcome recorded |
| — | NCT04437108 Comparator | Jul 2020 → Apr 2022 | overactive bladder, urethral syndrome | Mansoura University | Completed | No outcome recorded |
| — | NCT03787654 Comparator | Mar 2019 → Dec 2022 | urinary bladder disorder | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Unknown | No outcome recorded |
| — | NCT03662893 Comparator | Jan 2015 → Dec 2017 | overactive bladder | Ankara Training and Research Hospital | Completed | No outcome recorded |
| — | NCT02452879 Comparator | Oct 2014 → Oct 2015 | overactive bladder | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Unknown | No outcome recorded |
| — | NCT02047032 Comparator | Apr 2014 → Aug 2016 | — | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Completed | No outcome recorded |
| — | NCT01595152 Comparator | May 2012 → May 2013 | overactive bladder | Rambam Health Care Campus | Unknown | No outcome recorded |
| — | NCT01470001 Comparator | Nov 2011 → Sep 2015 | — | University of Wisconsin, Madison | Completed | No outcome recorded |
| — | NCT01028014 Comparator | Apr 2010 → Apr 2011 | urethral disorder | University of Alabama at Birmingham | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2021-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths upsher-smith.com ↗
Osaka, Japan – February 15, 2021 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for eight generic drugs with 20 strengths. |
| 2020-10-20 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives Final Approval from USFDA for Solifenacin Succinate Tablets zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Solifenacin Succinate Tablets, (US RLD: Vesicare ® Tablets) in the strengths of 5 mg and 10 mg. |
| 2019-05-21 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Solifenacin Succinate Tablets, 5 mg and 10 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Solifenacin Succinate Tablets, 5 mg and 10 mg |
| 2019-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 21st May, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Solifenacin Succinate Tablets, 5 mg and 10 mg. |
| 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 |
| 2018-03-09 | Astellas Pharma Inc | Regulatory Astellas Received Approval for Solifenacin Oral Suspension for Pediatric Patients in Europe astellas.com ↗
Current approval is addition of a pediatric indication. |
| 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. |
| 2012-03-27 | Astellas Pharma Inc | Regulatory ASTELLAS FILES REGULATORY SUBMISSION FOR EC905 - A NEW FIXED DOSE COMBINATION TREATMENT FOR MALE LUTS astellas.com ↗
ASTELLAS PHARMA EUROPE Ltd., the European subsidiary of Tokyo – based Astellas Pharma Inc.(Tokyo:4503) today announced the submission of a Market Authorisation Application for EC905 in the Netherlands. |
| 2009-12-22 | Astellas Pharma Inc | Regulatory Application for Orally Disintegrating Tablet YM905 in Japan astellas.com ↗
Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Masafumi Nogimori) announced that it submitted an application for market authorization for “orally disintegrating tablet YM905 (generic name: solifenacin succinate)“ to the Pharmaceuticals and Medical Devices Agency (PMDA) on December 22, 2009 in Japan. |
| 2006-04-20 | Astellas Pharma Inc | Regulatory Announcement of the Acquisition of Marketing Approval for the Overactive Bladder Treatment Vesicare Tablet in Japan astellas.com ↗
Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) has obtained marketing approval for its overactive bladder treatment Vesicare (YM905) with the indication of urinary frequency, urgency, and urge incontinence associated with overactive bladder (OAB*). |
All press releases naming this drug 16 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 148 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | solifenacin | “Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet...” NCT01953848 ↗128“Patients will receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by...” NCT07711808 ↗ “Solifenacin reduced mean urgency episodes/day versus placebo in the severe subgroup (-4.6 vs. -3.1, p = 0.1150), similar to the significant reduction observed in the FAS (-3.9...” PMID 20707767 ↗ Oct 2010 “A Randomized Controlled Trial Comparing Mirabegron and Solifenacin Combination Therapy Versus Desmopressin Monotherapy in Treatment of Children With Primary Mono-Symptomatic...” NCT07199894 ↗ “This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a...” NCT01943487 ↗ “the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®).” NCT04819360 ↗ “solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation” NCT03038321 ↗ “combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS)” PMID 22831853 ↗ Jul 2012 “Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)” NCT03662893 ↗ “single dose of solifenacin and tamsulosin administered as combination tablet EC905.” NCT01953861 ↗ “Solifenacin 5 mg tablet orally once daily for 30 days” NCT03817931 ↗ |
| Known as | NSC-759144 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1734 ↗ |
| Known as | Sofenacin | “Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg...” NCT06955533 ↗ |
| Known as | SOLI | “combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS)” PMID 22831853 ↗ Jul 2012 |
| Known as | solifenacin free base | “Blood samples for pharmacokinetic (PK) analysis of tamsulosin HCl and solifenacin free base are collected” NCT01953848 ↗ |
| Known as | solifenacin succinate | “Patients will receive solifenacin succinate 5 mg, an oral selective M3 antimuscarinic, taken once daily for 2 months. Solifenacin reduces overactive bladder symptoms by...” NCT07711808 ↗37“Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into...” NCT00573508 ↗ “The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor...” NCT01981954 ↗ “The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.” NCT01340027 ↗ “The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose.” NCT01539707 ↗ “This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.” NCT01018264 ↗ “Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study.” PMID 19143854 ↗ Nov 2008 “In Period 1, subjects are randomized to receive one of the two final combination tablet formulations of tamsulosin HCl and solifenacin succinate.” NCT01953848 ↗ “the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®).” NCT04819360 ↗ “tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)” NCT01021332 ↗ “solifenacin succinate 5 mg orally once daily for the duration of 12 weeks” NCT07416968 ↗ |
| Known as | Solifenacina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1734 ↗ |
| Known as | Solifenacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1734 ↗ |
| Known as | Succinate of Solifenacin | “Drug: Succinate of Solifenacin” NCT02805452 ↗ |
| Known as | VESIcare | “Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will...” NCT02805452 ↗7“Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet...” NCT01953848 ↗ “This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.” NCT01018264 ↗ “Solifenacin Succinate 5 MG Oral Tablet [Vesicare]” NCT05709990 ↗ “Solifenacin Succinate (VESIcare)” NCT00584090 ↗ “Vesicare (solifenacin)” NCT00821184 ↗ |
| Known as | Vesicare (Solifenacin) | “Vesicare (Solifenacin)” NCT01215721 ↗ |
| Known as | Vesicare ls | ChEMBL registry synonym — accepted as the source's own label CHEMBL1734 ↗ |
| Known as | YM-67905 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1734 ↗ |
| Known as | YM-905 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1734 ↗ |
| Action | Inhibit | “We compared the effects of non-selective (fesoterodine) and M(3)-selective (solifenacin) antimuscarinics on gastrointestinal transit in healthy women.” PMID 23171069 ↗ Nov 20122“Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1734 ↗ “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1734 ↗ |
| Modality | Small molecule | — CHEMBL1734 ↗ |
| Route | Oral | “Oral” NCT00333112 ↗ |
| Target | CHRM2 | “Muscarinic acetylcholine receptor M2 antagonist” CHEMBL1734 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1734 ↗ |