Tamsulosin

also known as Tamsulosin Hydrochloride · Flomax · Tamsulosin HCl · Harnal D · Omnic OCAS · Harnal · HIP1402 · Tamsulosine · +40 more

Other / unclassified

Developed for: benign prostatic hyperplasia · urinary tract obstruction · urinary bladder disorder · urolithiasis · erectile dysfunction · ureterolithiasis · overactive bladder · nephrolithiasis
+18 more
· chronic prostatitis · prostate cancer · urinary tract infection · chronic renal failure syndrome · endocrine exophthalmos · eyelid disorder · hypertensive disorder · posterior urethral valve · prostate neoplasm · prostatitis · ureteral disorder · urethral syndrome · urinary system disorder · diabetic macular edema · hyperplasia · nocturnal enuresis · premature ejaculation · urinary bladder, atony of
Investigated by: Boehringer Ingelheim · GlaxoSmithKline · Astellas Pharma Europe B.V. · Hanmi Pharmaceutical Company Limited · Astellas Pharma Inc · Chong Kun Dang Pharmaceutical
+86 more
· Assistance Publique - Hôpitaux de Paris · Astellas Pharma Taiwan, Inc. · Beni-Suef University · Berlin-Chemie Menarini · Chongqing Medical University · Emory University · Hackensack Meridian Health · Jeil Pharmaceutical Co., Ltd. · MaineHealth · Mansoura University · Mayo Clinic · Ministry of Health, France · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Pierre Fabre Laboratories · Samsung Medical Center · The Cleveland Clinic · University of Wisconsin, Madison · ABRAHAM J & PHYLLIS KATZ FOUNDATION · Addpharma Inc. · Ain Shams University · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Anand Rughani, MD · Antonio Nocito, MD · Armed Forces Institute of Urology, Rawalpindi · Asan Medical Center · Ascension Health · Astellas Pharma Inc · Astellas Pharma US, Inc. · CHU de Quebec-Universite Laval · Case Comprehensive Cancer Center · Chiang Mai University · Dr. J. Curtis Nickel · Eli Lilly and Company · Endeavor Health · Fayoum University Hospital · Fuling Central Hospital of Chongqing City · GL Pharm Tech Corporation · Gangnam Severance Hospital · Gundersen Lutheran Medical Foundation · Hadassah Medical Organization · Hospital Regional de Alta Especialidad del Bajio · Il-Yang Pharm. Co., Ltd. · IlDong Pharmaceutical Co Ltd · Jewish Hospital, Cincinnati, Ohio · Johns Hopkins University · Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Maine Medical Center Mentored Research Committee · McMaster University · Memorial Health University Medical Center · Merck Sharp & Dohme LLC · National University Hospital, Singapore · National University of Singapore · Nova Scotia Health Authority · Nîmes University Hospital · Pedro de Figueiredo Buchalla · Peking University First Hospital · Penang Hospital, Malaysia · Pontificia Universidad Catolica de Chile · Rennes University Hospital · Sengkang General Hospital · Seoul National University Hospital · Sheba Medical Center · Siami, Paul F., M.D. · Singapore General Hospital · Soonchunhyang University Hospital · Soroka University Medical Center · Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Taiyuan Central Hospital of Shanxi Medical University · The Catholic University of Korea · Timothy Boone, MD, PhD · Turku University Hospital · UMass Memorial Health · University Hospitals Cleveland Medical Center · all 92 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	FLOMAX	—	2009-12-22	fda.gov ↗
Approved	US (FDA)	FLOMAX	—	1997-04-15	fda.gov ↗

Trials 131 · started per year

today

US approved 1997

19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 03 trials
Phase 0	NCT05657990	Apr 2023 → Jun 2027 expected	urinary tract obstruction	Hackensack Meridian Health	Recruiting	No outcome recorded
Phase 0	NCT04232683	Dec 2019 → Oct 2025	urinary tract obstruction	The Cleveland Clinic	Completed	No outcome recorded
Phase 0	NCT03314259	Dec 2017 → Dec 2018	—	National University Hospital, Singapore	Unknown	No outcome recorded
Phase 134 trials · 1 met primary
Phase 1	NCT07444385	Feb → Apr 2026 overdue	benign prostatic hyperplasia	Addpharma Inc.	Recruiting	No outcome recorded
Phase 1	NCT07322991	Oct → Dec 2025	—	Il-Yang Pharm. Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT07156916	Sep 2025 → Mar 2026 overdue	—	Berlin-Chemie Menarini	Recruiting	No outcome recorded
Phase 1	NCT07146711	Mar → Oct 2025 overdue	—	Berlin-Chemie Menarini	Active not recruiting	No outcome recorded
Phase 1	NCT05790902	Sep 2022 → Feb 2023	urolithiasis	Armed Forces Institute of Urology, Rawalpindi	Completed	No outcome recorded
Phase 1	NCT04084197	Dec 2018	—	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT02615782	Dec 2015 → Apr 2016	benign prostatic hyperplasia	Chong Kun Dang Pharmaceutical	Completed	No outcome recorded
Phase 1	NCT02715401	Oct → Nov 2015	benign prostatic hyperplasia, erectile dysfunction	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT02529800	Sep → Oct 2015	—	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT02494349	Aug → Nov 2015	benign prostatic hyperplasia, overactive bladder	Jeil Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT02509104	Jul → Oct 2015	benign prostatic hyperplasia	GlaxoSmithKline	Completed	Met primary
Phase 1	NCT02712411	Jul → Aug 2015	erectile dysfunction, prostate disorder	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT02247505	Sep → Oct 2014	—	Chong Kun Dang Pharmaceutical	Completed	No outcome recorded
Phase 1	NCT02184585	Jul 2014 → Feb 2015	prostate disorder	GlaxoSmithKline	Completed	Mixed
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	NCT02138773	Apr → Jul 2014	—	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1	NCT02239484	Mar → Sep 2014	benign prostatic hyperplasia, erectile dysfunction	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT01957189	Oct 2013 → Jan 2014	benign prostatic hyperplasia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01471678	Jun → Sep 2011	benign prostatic hyperplasia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01254071	Sep → Dec 2010	benign prostatic hyperplasia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01489696	Aug 2010 → Feb 2011	cardiovascular disorder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1	NCT01953861	Apr → Jun 2010	—	Astellas Pharma Europe B.V.	Completed	No outcome recorded
Phase 1	NCT01953848	Apr → Jul 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	NCT01100021	Feb → Mar 2010	erectile dysfunction	VIVUS LLC	Completed	No outcome recorded
Phase 1	NCT01943487	Aug → Dec 2009	—	Astellas Pharma Europe B.V.	Completed	No outcome recorded
Phase 1	NCT02264184	Sep → Dec 2008	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT02264171	Apr → Jun 2008	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00609596	Feb → Apr 2008	benign prostatic hyperplasia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00537654	Oct 2007 → Feb 2008	benign prostatic hyperplasia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02266537	Nov 2005 → Feb 2006	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT02266524	Jan → Apr 2005	urinary system disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00223717	Jan 2001 → Jan 2017	hypertensive disorder	Vanderbilt University	Completed	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT03609580	May 2018 → Mar 2027 expected	—	Hackensack Meridian Health	Recruiting	No outcome recorded
Phase 212 trials · 1 met primary · 2 missed
Phase 2	NCT07623876	May 2026 → Apr 2027 expected	urolithiasis	Beni-Suef University	Recruiting	No outcome recorded
Phase 2	NCT06262048	Oct 2024 → Dec 2025 overdue	urinary tract obstruction	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Recruiting	No outcome recorded
Phase 2	NCT04597372	Nov 2021 → Dec 2026 expected	urinary tract obstruction	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Recruiting	No outcome recorded
Phase 2	NCT04859660	Apr 2021 → Jun 2023	urinary tract obstruction	University of Arizona	Completed	Missed primary
Phase 2	NCT03314025	Oct 2017 → Oct 2022	urinary tract obstruction	CHU de Quebec-Universite Laval	Unknown	Missed primary
Phase 2	NCT01726270	Nov 2012 → Mar 2013	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT00507455	Jun 2007 → Aug 2008	urinary tract obstruction	Astellas Pharma Inc	Completed	Met primary
Phase 2	NCT00340704	Apr 2006 → Jun 2009	urinary bladder disorder	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT02244281	May 2001 → Nov 2003	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT02244294	Mar 2001 → Jun 2005	benign prostatic hyperplasia	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT04552431	Sep 1997 → Aug 2003	chronic prostatitis	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 2	NCT00478998	—	ureterolithiasis	Hadassah Medical Organization	Unknown	No outcome recorded

Phase 2/32 trials · 1 met primary · 1 missed
Phase 2/3	NCT03524339	Aug 2018 → Jun 2020	female stress incontinence, pelvic organ prolapse, urinary tract obstruction	University Hospitals Cleveland Medical Center	Completed	Met primary
Phase 2/3	NCT00796614	Jan 2008 → Feb 2009	urinary bladder disorder	Boehringer Ingelheim	Completed	Missed primary
Phase 326 trials · 4 met primary · 2 missed
Phase 3	NCT06966804	Jun 2025 → May 2026 overdue	—	Penang Hospital, Malaysia	Recruiting	No outcome recorded
Phase 3	NCT06737016	Nov 2024 → May 2026 overdue	posterior urethral valve	Mansoura University	Recruiting	No outcome recorded
Phase 3	NCT06257576	Feb 2024 → Nov 2025	urinary tract infection	Emory University	Completed	No outcome recorded
Phase 3	NCT05753670	Jul 2023 → May 2024	urinary tract obstruction	Endeavor Health	Completed	Missed primary
Phase 3	NCT05197088	Mar 2022 → Jun 2025	urolithiasis	Sengkang General Hospital	Completed	No outcome recorded
Phase 3	NCT04159077	Jul 2021 → Dec 2023	—	McMaster University	Unknown	No outcome recorded
Phase 3	NCT05023824	Dec 2020 → Dec 2023	benign prostatic hyperplasia	Gangnam Severance Hospital	Unknown	Met primary
Phase 3	NCT02869971	Aug 2016 → Dec 2020	benign prostatic hyperplasia	Assistance Publique - Hôpitaux de Paris	Completed	Met primary
Phase 3	NCT02862483	Mar 2016 → Mar 2017	benign prostatic hyperplasia, erectile dysfunction	IlDong Pharmaceutical Co Ltd	Unknown	No outcome recorded
Phase 3	NCT02573311	Sep 2015 → Aug 2016	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 3	NCT03246880	Sep 2015 → Apr 2016	benign prostatic hyperplasia	Chong Kun Dang Pharmaceutical	Completed	No outcome recorded
Phase 3	NCT02486653	Aug 2015 → Apr 2018	urinary tract infection, urinary tract obstruction	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 3	NCT02518971	Aug 2015 → Jun 2018	urinary bladder disorder	University of Michigan	Terminated	No outcome recorded
Phase 3	NCT02390882	Oct 2014 → May 2015	benign prostatic hyperplasia	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 3	NCT02303769	Mar 2014 → May 2015	benign prostatic hyperplasia	GL Pharm Tech Corporation	Completed	No outcome recorded
Phase 3	NCT01937871	Sep 2013 → Dec 2015	benign prostatic hyperplasia, erectile dysfunction	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01534351	Aug → Nov 2013	benign prostatic hyperplasia	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01830829	Apr 2013 → Oct 2014	benign prostatic hyperplasia, chronic prostatitis	Dr. J. Curtis Nickel	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01747993	Jan 2013 → Jun 2014	urinary tract obstruction	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded
Phase 3	NCT01568918	May 2012 → Nov 2019	urinary bladder disorder	Mayo Clinic	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01021332	Apr 2010 → Dec 2011	benign prostatic hyperplasia	Astellas Pharma Europe B.V.	Completed	No outcome recorded
Phase 3	NCT01018511	Jan 2010 → Mar 2011	benign prostatic hyperplasia	Astellas Pharma Europe B.V.	Completed	Met primary
Phase 3	NCT00606983	May 2007 → Sep 2010	rectal carcinoma, urinary tract obstruction	Seoul National University Hospital	Completed	No outcome recorded
Phase 3	NCT00244309	Nov 2005 → Jun 2006	prostate cancer	Case Comprehensive Cancer Center	Completed	No outcome recorded
Phase 3	NCT00090103	Nov 2003 → Apr 2009	benign prostatic hyperplasia	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT00151567	Feb 2002 → Dec 2006	ureterolithiasis	Rennes University Hospital	Completed	Missed primary

Phase 441 trials · 1 met primary · 3 missed
Phase 4	NCT07174349	Oct 2026 → Jan 2027 expected	urinary tract obstruction	Mayo Clinic	Recruiting	No outcome recorded
Phase 4	NCT07310797	Feb 2026 → Dec 2029 expected	ureterolithiasis	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Recruiting	No outcome recorded
Phase 4	NCT07276919	Feb 2026 → Jan 2028 expected	urinary tract obstruction	Peking University First Hospital	Not yet recruiting	No outcome recorded
Phase 4	NCT07308002	Jan 2026 → Jan 2027 expected	benign prostatic hyperplasia	Mansoura University	Not yet recruiting	No outcome recorded
Phase 4	NCT07124299	Jan 2024 → Jan 2026 overdue	nephrolithiasis	Pedro de Figueiredo Buchalla	Recruiting	No outcome recorded
Phase 4	NCT07847866	Jun 2023 → Jun 2025	urolithiasis	Singapore General Hospital	Completed	No outcome recorded
Phase 4	NCT06809205	Apr 2023 → May 2024	benign prostatic hyperplasia	Fayoum University Hospital	Completed	No outcome recorded
Phase 4	NCT06001619	Dec 2022 → Oct 2024 overdue	benign prostatic hyperplasia, prostate cancer	Turku University Hospital	Recruiting	No outcome recorded
Phase 4	NCT04682366	Oct 2021 → Nov 2022	urinary tract obstruction	Wake Forest University Health Sciences	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT05415748	Sep 2021 → Jul 2022	benign prostatic hyperplasia	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT04994431	Aug 2021 → Oct 2023	urinary tract obstruction	University of Massachusetts, Worcester	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04491526	Nov 2020 → Feb 2026	—	Antonio Nocito, MD	Terminated	No outcome recorded
Phase 4	NCT03799120	Feb 2019 → Dec 2021	ureteral disorder	Gundersen Lutheran Medical Foundation	Unknown	No outcome recorded
Phase 4	NCT03614052	Jun 2018 → Jan 2020	ureterolithiasis, urolithiasis	Pontificia Universidad Catolica de Chile	Terminated	No outcome recorded
Phase 4	NCT04434378	Nov 2017 → Feb 2020	urinary bladder disorder	Jewish Hospital, Cincinnati, Ohio	Terminated	No outcome recorded
Phase 4	NCT03027115	Jan 2017 → Jan 2020	urinary tract obstruction	Memorial Health University Medical Center	Unknown	No outcome recorded
Phase 4	NCT02958878	Jan 2017 → Nov 2018	urinary bladder disorder	Ascension Health	Completed	No outcome recorded
Phase 4	NCT06105827	Oct 2016 → Apr 2019	ureterolithiasis	Xintian Pharmaceutical	Completed	No outcome recorded
Phase 4	NCT02919436	Mar 2016 → Jan 2020	urinary tract obstruction	Anand Rughani, MD	Completed	Missed primary
Phase 4	NCT02121613	Apr 2014 → Jun 2016	benign prostatic hyperplasia	Pierre Fabre Laboratories	Completed	No outcome recorded
Phase 4	NCT02095665	Jan 2014 → Mar 2018	nephrolithiasis	Nova Scotia Health Authority	Completed	No outcome recorded
Phase 4	NCT02180789	Mar 2013 → Jan 2015	benign prostatic hyperplasia	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT01777269	Feb 2013 → Apr 2016	benign prostatic hyperplasia	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT01741454	Nov 2012 → Mar 2018	ureteral obstruction	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT01673490	Jun 2012 → Mar 2015	benign prostatic hyperplasia	GlaxoSmithKline	Terminated	No outcome recorded
Phase 4	NCT01604811	Jun 2012 → Oct 2013	benign prostatic hyperplasia	Pierre Fabre Laboratories	Completed	No outcome recorded
Phase 4	NCT01457573	Oct 2011 → Jul 2014	—	Timothy Boone, MD, PhD	Completed	No outcome recorded
Phase 4	NCT01294592	Dec 2010 → Oct 2013	benign prostatic hyperplasia	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT01533597	Dec 2010 → Dec 2013	overactive bladder	Soonchunhyang University Hospital	Completed	No outcome recorded
Phase 4	NCT01167062	Jun 2010 → Apr 2011	ureterolithiasis	Chiang Mai University	Unknown	No outcome recorded
Phase 4	NCT04819828	Jan 2010 → Aug 2016	urolithiasis	Hospital Regional de Alta Especialidad del Bajio	Completed	Missed primary
Phase 4	NCT01010048	Oct 2009	urolithiasis	Chongqing Medical University	Unknown	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	NCT00451061	Apr 2007 → ?	urinary tract obstruction	Soroka University Medical Center	Unknown	No outcome recorded
Phase 4	NCT00701779	Sep 2005 → Jul 2009	benign prostatic hyperplasia	Siami, Paul F., M.D.	Completed	No outcome recorded
Phase 4	NCT00147654	Nov 2004 → May 2006	overactive bladder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT02245490	Jan 2003 → Apr 2004	benign prostatic hyperplasia	Boehringer Ingelheim	Completed	No outcome recorded
Phase 4	NCT02244255	Aug 1998 → Jun 2000	benign prostatic hyperplasia	Boehringer Ingelheim	Completed	No outcome recorded
Phase 4	NCT02244242	Jul 1998 → Aug 1999	benign prostatic hyperplasia	Boehringer Ingelheim	Completed	No outcome recorded
Phase 4	NCT02244229	Apr 1998 → Nov 2000	benign prostatic hyperplasia	Boehringer Ingelheim	Completed	No outcome recorded
Phase 4	NCT07715448	? → Jan 2026	benign prostatic hyperplasia, erectile dysfunction	Beni-Suef University	Completed	No outcome recorded

Phase not applicable12 trials
—	NCT05439902	Oct 2022 → Mar 2026	multiple sclerosis, urethral syndrome, urinary bladder disorder	Nîmes University Hospital	Unknown	No outcome recorded
—	NCT07841340	Sep 2022 → Apr 2023	—	Ain Shams University	Completed	No outcome recorded
—	NCT04807569	Apr 2021 → Apr 2022	urinary bladder disorder	Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation	Unknown	No outcome recorded
—	NCT04359979	May 2020 → May 2023	endocrine exophthalmos, eyelid disorder	Sheba Medical Center	Unknown	No outcome recorded
—	NCT02684344	Feb 2016 → Dec 2017	urinary tract obstruction	University of Rochester	Terminated	No outcome recorded Stop: Enrollment
—	NCT02033798	Feb 2014 → Jan 2016	benign prostatic hyperplasia, chronic renal failure syndrome	The Catholic University of Korea	Unknown	No outcome recorded
—	NCT01404637	Jul 2011 → Jul 2013	benign prostatic hyperplasia	Samsung Medical Center	Unknown	No outcome recorded
—	NCT01209988	Apr 2010 → Dec 2011	prostate neoplasm	Asan Medical Center	Unknown	No outcome recorded
—	NCT00913315	Aug → Oct 2009	prostatitis	Chongqing Medical University	Unknown	No outcome recorded
—	NCT00954889	Aug 2009 → Nov 2011	benign prostatic hyperplasia	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00600405	Aug 2006 → Nov 2007	nephrolithiasis, ureterolithiasis	MaineHealth	Completed	No outcome recorded
—	NCT00209131	Apr 2005 → Feb 2009	urolithiasis	Emory University	Terminated	No outcome recorded Stop: Enrollment

Comparator or background therapy102 trials
Phase 0	NCT03274700 Comparator	Oct 2017 → Sep 2018	ureterolithiasis	Assiut University	Unknown	No outcome recorded
Phase 1	NCT07091669 Comparator	Jun → Aug 2025 overdue	—	Berlin-Chemie Menarini	Active not recruiting	No outcome recorded
Phase 1	NCT04147806 Background	Aug 2016 → Jul 2026 overdue	prostate cancer	Albert Einstein College of Medicine	Active not recruiting	No outcome recorded
Phase 1	NCT02645890 Comparator	Nov → Dec 2015	benign prostatic hyperplasia	Chong Kun Dang Pharmaceutical	Completed	No outcome recorded
Phase 1	NCT01829893 Comparator	Jan → Feb 2012	benign prostatic hyperplasia	Korea University Anam Hospital	Completed	No outcome recorded
Phase 1	NCT02634489 Comparator	Mar → Jul 2009	benign prostatic hyperplasia	Astellas Pharma Europe B.V.	Completed	No outcome recorded
Phase 1	NCT01149746 Comparator	Dec 2004	—	Teva Pharmaceuticals USA	Completed	No outcome recorded
Phase 1	NCT01149733 Comparator	Nov 2004	—	Teva Pharmaceuticals USA	Completed	No outcome recorded
Phase 1/2	NCT03976934 Comparator	Feb 2020 → Oct 2021	—	Georgios Koukoulis	Completed	No outcome recorded
Phase 1/2	NCT03384524 Comparator	Mar 2018 → May 2019	diabetic macular edema	Andrew Moshfeghi, MD, MBA	Withdrawn	No outcome recorded
Phase 2	NCT07617909 Comparator	May → Oct 2026 expected	ureterolithiasis, urolithiasis	Beni-Suef University	Recruiting	No outcome recorded
Phase 2	NCT05401032 Comparator	Dec 2024 → Dec 2026 expected	benign prostatic hyperplasia	Clinical Academic Center (2CA-Braga)	Recruiting	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	NCT02038868 Comparator	Jul 2013 → Apr 2014	benign prostatic hyperplasia	Astellas Pharma Inc	Completed	No outcome recorded
Phase 2	NCT01589263 Comparator	Jun 2012 → Sep 2019	benign prostatic hyperplasia	VA Office of Research and Development	Completed	No outcome recorded
Phase 2	NCT00540124 Comparator	Oct 2007 → Jun 2008	benign prostatic hyperplasia	Eli Lilly and Company	Completed	Missed primary
Phase 2	NCT00457457 Comparator	May 2007 → Apr 2008	benign prostatic hyperplasia	Pfizer	Completed	No outcome recorded
Phase 2	NCT00510406 Comparator	Jan → Sep 2007	benign prostatic hyperplasia	Astellas Pharma Inc	Completed	No outcome recorded
Phase 2/3	NCT05531344 Comparator	Aug 2020 → Jul 2022	benign prostatic hyperplasia	REMD Medical Technology	Completed	No outcome recorded
Phase 2/3	NCT01175382 Comparator	Jul 2010 → Jul 2015	overactive bladder	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 3	NCT06803030 Comparator	Aug → Dec 2025 overdue	—	Bir Hospital	Recruiting	No outcome recorded
Phase 3	NCT06843538 Comparator	Feb 2025 → Feb 2026 overdue	urinary tract obstruction	TriHealth Inc.	Recruiting	No outcome recorded
Phase 3	NCT06264414 Comparator	Feb 2025 → Jun 2026 overdue	benign prostatic hyperplasia, erectile dysfunction	EMS	Not yet recruiting	No outcome recorded
Phase 3	NCT05941806 Comparator	Nov 2023 → Jul 2027 expected	urinary tract obstruction	CHU de Quebec-Universite Laval	Recruiting	No outcome recorded
Phase 3	NCT06707181 Comparator	Nov 2023 → May 2024	ureterolithiasis	Beni-Suef University	Completed	No outcome recorded
Phase 3	NCT05570084 Comparator	May 2022 → Jun 2023	urolithiasis	Princess Margaret Hospital, Hong Kong	Unknown	No outcome recorded
Phase 3	NCT04325880 Comparator	Dec 2021 → Jun 2022	ureteral disorder	Mansoura University	Unknown	No outcome recorded
Phase 3	NCT04245566 Comparator	Sep 2021 → Dec 2022	benign prostatic hyperplasia	Dominik Abt	Unknown	No outcome recorded
Phase 3	NCT04185441 Comparator	Mar 2021 → Oct 2023	benign prostatic hyperplasia, erectile dysfunction	EMS	Completed	No outcome recorded
Phase 3	NCT06754410 Comparator	Mar 2021 → Mar 2024	ureterolithiasis	South Valley University	Completed	No outcome recorded
Phase 3	NCT03879746 Comparator	Apr 2019 → Apr 2020	premature ejaculation	Assiut University	Unknown	No outcome recorded
Phase 3	NCT04557202 Comparator	Sep 2017 → Aug 2018	—	Ain Shams University	Completed	No outcome recorded
Phase 3	NCT02972268 Background	Feb 2016 → Nov 2017	benign prostatic hyperplasia	Jeil Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT02827578 Background	Jan 2016 → Aug 2017	benign prostatic hyperplasia	IlDong Pharmaceutical Co Ltd	Unknown	No outcome recorded
Phase 3	NCT02058368 Background	Feb 2014 → Mar 2017	benign prostatic hyperplasia	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02003742 Comparator	Sep 2013 → Jan 2015	—	RECORDATI GROUP	Terminated	No outcome recorded
Phase 3	NCT01560091 Comparator	Mar 2012 → Feb 2013	nephrolithiasis	Albert Einstein Healthcare Network	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT01203371 Comparator	Jan → Sep 2011	hyperplasia	Apsen Farmaceutica S.A.	Withdrawn	No outcome recorded
Phase 3	NCT00970632 Comparator	Oct 2009 → Jan 2011	benign prostatic hyperplasia	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT00861757 Comparator	Mar 2009 → Jun 2010	benign prostatic hyperplasia	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01215708 Comparator	Aug 2006 → Jun 2010	nephrolithiasis	University of Sao Paulo General Hospital	Unknown	No outcome recorded
Phase 3	NCT00359905 Comparator	May 2006 → May 2007	benign prostatic hyperplasia	RECORDATI GROUP	Completed	Met primary
Phase 4	NCT07846579 Comparator	Dec 2026 → Dec 2028 expected	benign prostatic hyperplasia	Shanghai East Hospital	Not yet recruiting	No outcome recorded
Phase 4	NCT07797348 Comparator	Sep 2026 → Sep 2028 expected	benign prostatic hyperplasia, urinary tract obstruction	Zenflow, Inc.	Not yet recruiting	No outcome recorded
Phase 4	NCT07650968 Comparator	Jun 2026 → May 2027 expected	benign prostatic hyperplasia, urinary tract obstruction	Beni-Suef University	Recruiting	No outcome recorded
Phase 4	NCT07654413 Background	Jun 2026 → Nov 2027 expected	benign prostatic hyperplasia, urinary tract obstruction	Beni-Suef University	Recruiting	No outcome recorded
Phase 4	NCT07467343 Comparator	Mar → Sep 2026 overdue	benign prostatic hyperplasia	Ain Shams University	Not yet recruiting	No outcome recorded
Phase 4	NCT07815379 Comparator	Oct 2025 → Oct 2026 expected	benign prostatic hyperplasia	Mansoura University	Active not recruiting	No outcome recorded
Phase 4	NCT07357324 Background	Dec 2024 → Dec 2026 expected	benign prostatic hyperplasia, nocturnal enuresis	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Recruiting	No outcome recorded
Phase 4	NCT05977647 Comparator	Sep 2024 → May 2025	ureterolithiasis	Getz Pharma	Completed	No outcome recorded
Phase 4	NCT07114848 Comparator	Jun → Dec 2024	ureterolithiasis	Liaquat National Hospital & Medical College	Completed	No outcome recorded
Phase 4	NCT06753526 Comparator	Jul 2023 → Apr 2024	ureterolithiasis	Sohag University	Completed	No outcome recorded
Phase 4	NCT05551221 Comparator	Sep 2022 → Sep 2024	benign prostatic hyperplasia	Xintian Pharmaceutical	Completed	No outcome recorded
Phase 4	NCT05537272 Comparator	Sep 2022 → Sep 2023	urinary bladder disorder	University Hospital of Split	Unknown	No outcome recorded
Phase 4	NCT07134907 Comparator	Jul 2022 → Jul 2024	benign prostatic hyperplasia	Shanghai Huilun Pharmaceutical Co., Ltd.	Completed	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	NCT04987892 Comparator	Dec 2021 → May 2025	benign prostatic hyperplasia	NeoTract, Inc.	Unknown	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	NCT05494567 Comparator	Nov 2021 → Aug 2022	benign prostatic hyperplasia, overactive bladder	Mansoura University	Unknown	No outcome recorded
Phase 4	NCT05818670 Comparator	Nov 2020 → Sep 2021	benign prostatic hyperplasia	Mansoura University	Completed	No outcome recorded
Phase 4	NCT04641507 Comparator	Jan 2020 → Mar 2022	ureterolithiasis	Beni-Suef University	Unknown	No outcome recorded
Phase 4	NCT03808155 Comparator	Aug 2019 → Oct 2024	arthropathy, urinary tract obstruction	Kantonsspital Graubünden	Completed	No outcome recorded
Phase 4	NCT05890235 Comparator	Nov 2018 → Jul 2022	chronic prostatitis	Xintian Pharmaceutical	Completed	Met primary
Phase 4	NCT03750656 Comparator	Nov 2018 → Aug 2020	—	University of Kansas Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04107896 Comparator	Aug 2017 → Aug 2018	benign prostatic hyperplasia	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Completed	No outcome recorded
Phase 4	NCT03229889 Comparator	Jun 2017 → Mar 2022	nephrolithiasis	University of California, Irvine	Completed	No outcome recorded
Phase 4	NCT02757768 Background	Jun 2016 → Aug 2018	benign prostatic hyperplasia, overactive bladder	Astellas Pharma Global Development, Inc.	Completed	Met primary
Phase 4	NCT02656173 Background	Jan 2016 → Jul 2017	overactive bladder	Astellas Pharma Inc	Completed	Met primary
Phase 4	NCT03144596 Comparator	Oct 2015 → Feb 2016	benign prostatic hyperplasia, optic choroid disorder, pupil disorder	Kocatepe University	Completed	No outcome recorded
Phase 4	NCT03856242 Comparator	Sep 2015 → Sep 2017	benign prostatic hyperplasia, ischemic disease	I.M. Sechenov First Moscow State Medical University	Completed	No outcome recorded
Phase 4	NCT02443844 Comparator	Feb 2015 → Feb 2018	urinary bladder cancer	Diskapi Teaching and Research Hospital	Unknown	No outcome recorded
Phase 4	NCT02034604 Comparator	Dec 2013 → Dec 2016	—	Samsung Medical Center	Completed	No outcome recorded
Phase 4	NCT02369744 Comparator	Mar → Oct 2013	ureterolithiasis	Albert Einstein Healthcare Network	Terminated	No outcome recorded
Phase 4	NCT01880619 Comparator	Jan 2013 → May 2014	—	Mansoura University	Completed	No outcome recorded
Phase 4	NCT01736033 Comparator	Feb 2012 → Feb 2017	benign prostatic hyperplasia	Seoul National University Hospital	Unknown	No outcome recorded
Phase 4	NCT00771394 Background	Oct 2008 → Jan 2010	benign prostatic hyperplasia, overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT00824200 Comparator	Jul 2008 → Feb 2014	nocturnal enuresis	Atlanta VA Medical Center	Completed	No outcome recorded
Phase 4	NCT00687388 Comparator	May 2008 → Mar 2012	benign prostatic hyperplasia	Samsung Medical Center	Withdrawn	No outcome recorded
Phase 4	NCT00382265 Comparator	Jan 2008 → Feb 2017	ureterolithiasis	Andrew Meltzer	Completed	No outcome recorded
Phase 4	NCT00333112 Background	May 2006 → Jan 2007	overactive bladder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT00379067 Comparator	Oct 2005 → Nov 2006	benign prostatic hyperplasia	Astellas Pharma Inc	Completed	No outcome recorded
—	NCT07562282 Comparator	Dec 2025 → Jul 2026 overdue	ureterolithiasis, urolithiasis	Ain Shams University	Recruiting	No outcome recorded
—	NCT06865430 Comparator	Mar → Sep 2025 overdue	benign prostatic hyperplasia	Ankara Training and Research Hospital	Recruiting	No outcome recorded
—	NCT07307261 Comparator	Oct 2024 → Oct 2025	—	Avraiem Talaat	Completed	No outcome recorded
—	NCT06867315 Comparator	May 2024 → May 2026 overdue	benign prostatic hyperplasia	First Affiliated Hospital of Zhejiang University	Recruiting	No outcome recorded
—	NCT06955533 Comparator	Apr → Aug 2024	—	Ain Shams University	Completed	No outcome recorded
—	NCT06020963 Comparator	Aug 2023 → Dec 2024	urinary bladder, atony of	Taichung Armed Forces General Hospital	Unknown	No outcome recorded
—	NCT06568718 Background	Mar 2023 → Feb 2024	benign prostatic hyperplasia	NPO Petrovax	Completed	No outcome recorded
—	NCT05236634 Comparator	May 2022 → May 2024	benign prostatic hyperplasia	Assiut University	Unknown	No outcome recorded
—	NCT05834270 Comparator	May → Dec 2022	benign prostatic hyperplasia, prostate neoplasm, urethral obstruction	Menoufia University	Completed	No outcome recorded
—	NCT07169773 Comparator	May 2022 → May 2023	benign prostatic hyperplasia	khaled Abdelsattar Gad Ibrahim	Completed	No outcome recorded
—	NCT06181175 Comparator	Oct 2021 → Oct 2024	benign prostatic hyperplasia, urinary tract obstruction	Azienda Ospedaliero Universitaria Maggiore della Carita	Unknown	No outcome recorded
—	NCT05094947 Background	Aug 2021 → Mar 2022	benign prostatic hyperplasia	Moscow State University of Medicine and Dentistry	Unknown	No outcome recorded
—	NCT05759767 Comparator	Feb 2021 → Dec 2023	nephrolithiasis	Mansoura University	Unknown	No outcome recorded
—	NCT03709992 Comparator	Dec 2020 → Aug 2024	ureteral obstruction, ureterolithiasis	Mansoura University	Suspended	No outcome recorded
—	NCT05032287 Comparator	Sep 2019 → May 2020	nephrolithiasis	Mansoura University	Completed	No outcome recorded
—	NCT06677177 Comparator	Feb 2016 → Nov 2022	—	ALI KAMAL M. SAMI	Completed	No outcome recorded
—	NCT02483793 Comparator	Jul 2015 → Dec 2016	urinary system disorder	Phoenix Children's Hospital	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT01028014 Comparator	Apr 2010 → Apr 2011	urethral disorder	University of Alabama at Birmingham	Completed	No outcome recorded
—	NCT00762424 Comparator	Jun 2007 → Jan 2011	urolithiasis	WellSpan Health	Completed	No outcome recorded
—	NCT00448123 Comparator	Feb 2007 → Sep 2011	ureterolithiasis, urolithiasis	Robert Swor	Completed	No outcome recorded
—	NCT00831701 Comparator	Sep 2006 → Nov 2008	ureterolithiasis	University of Zurich	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 23

Date	Issuer	Release
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).
2018-03-15	Hanmi Pharmaceutical Company Limited	Results <보도자료> 한미약품 ‘한미탐스0.4mg’ 3상 결과 SCI급 국제학술지 등재 hanmi.co.kr ↗ 연구 결과에 따르면, 한미탐스0.4mg은 Tamsulosin 0.2mg 대비 IPSS(국제 전립선 증상 점수)를 약 71% 더 감소시켜 유의하게 우수한 효과를 나타냈으며, 특히 중증환자(IPSS ≥ 20) 대상으로도 IPSS를 약 72% 더 감소시켰다.
2017-11-13	Veru Inc.	Results Veru Announces Tamsulosin DRS Bioequivalence Clinical Trial Results verupharma.com ↗ Dosing with Tamsulosin DRS fasted and Tamsulosin DRS fed were successfully shown to be bioequivalent with FLOMAX Fed based on AUC.
2017-08-16	Hanmi Pharmaceutical Company Limited	Results <보도자료> 한미약품 ‘구구탐스’ 3상 임상 결과, 국제학술지 등재 hanmi.co.kr ↗ 연구 결과, 탐스로신 0.4mg 복합제 투여군에서 대조군 대비 IPSS(국제 전립선 증상 점수)가 약 27% 더 감소되었으며, 성기능 개선 효과는 비열등함을 보였다.
2017-05-18	Hanmi Pharmaceutical Company Limited	Results <보도자료> 한미약품 ‘구구탐스’ 3상 결과, 美 비뇨기과학회 구연발표 hanmi.co.kr ↗ 발표 내용에 따르면, 탐스로신염산염 0.4mg 복합제 투여군에서 대조군 대비 IPSS(국제 전립선 증상 점수)가 약 27% 더 감소됐으며, 성기능 개선 효과는 비열등함을 확인했다.
2016-12-26	Hanmi Pharmaceutical Company Limited	Results <보도자료> 전립선비대증+발기부전 치료제 ‘구구탐스캡슐’ 출시 hanmi.co.kr ↗ 전립선비대증 및 발기부전 동반 남성환자 510명을 총 3개군으로 나눠 1일 1회 12주간 투약한 결과, 구구탐스캡슐이 타다라필(Tadalafil) 5mg 단일군 대비 IPSS(국제 전립선 증상 점수)를 약 27% 더 감소시킨 것으로 나타났다.
2016-10-21	Hanmi Pharmaceutical Company Limited	Regulatory <보도자료> ‘전립선비대증+발기부전’ 복합제 ‘구구탐스’ 허가 hanmi.co.kr ↗ 한미약품(대표이사 이관순, www.hanmi.co.kr)이 전립선비대증 치료 성분과 발기부전 치료 성분을 하나로 복합한 ‘구구탐스캡슐(성분 tamsulosin 0.4mg+tadalafil 5mg)’의 식약처 시판허가를 받았다고 21일 밝혔다.
2016-09-27	Hanmi Pharmaceutical Company Limited	Results <보도자료> ‘탐스로신·타다라필 복합제’ 3상 결과 세계성의학회 임상부문 최우수 연제상 선정 hanmi.co.kr ↗ 발표 내용에 따르면, 탐스로신 0.4mg 복합제 투여군에서 대조군 대비 IPSS(국제 전립선 증상 점수)가 약 28% 더 감소되었으며, 성기능 개선 효과는 비열등함을 보였다.
2016-05-12	Hanmi Pharmaceutical Company Limited	Results <보도자료> ‘한미탐스0.4mg’ 임상결과, 美비뇨기과학회 발표 hanmi.co.kr ↗ 발표 내용에 따르면, ‘한미탐스 0.4mg'은 탐스로신 0.2mg 대비 IPSS(국제 전립선 증상 점수)를 약 71% 더 감소시켜 유의하게 우수한 효과를 나타냈으며, 이상반응 발생률은 0.2mg와 유의한 차이가 없는 것으로 확인됐다.
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.
2012-02-07	Eli Lilly and Company	Results New Study Evaluates Cialis® in parallel with Tamsulosin in Men with Signs and Symptoms Suggestive of Benign Prostatic Hyperplasia lilly.com ↗
2010-07-16	Sun Pharmaceutical Industries, Inc.	Regulatory Sun Pharma announces USFDA approval for generic Flomax® sunpharma.com ↗
2010-06-13	GlaxoSmithKline	Regulatory FDA approves Jalyn™, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate gsk.com ↗ GlaxoSmithKline (NYSE: GSK) announced today the U.S. Food and Drug Administration (FDA) has approved Jalyn, a single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
2010-04-28	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces Launch of Generic Flomax® tevapharm.com ↗ today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of its generic version of Boehringer Ingelheim's Flomax® (tamsulosin hydrochloride) Capsules, 0.4 mg
2010-03-30	GlaxoSmithKline	Regulatory GSK receives European approval for Duodart® gsk.com ↗ GlaxoSmithKline (GSK) today announced that Duodart®, a fixed dose combination (FDC) of dutasteride (0.5mg), and tamsulosin (0.4mg) has received approval in Europe via the Decentralised Procedure with Germany acting as Reference Member State.
2010-03-21	GlaxoSmithKline	Regulatory GlaxoSmithKline announces Swiss approval of Duodart® gsk.com ↗ GlaxoSmithKline (GSK) announced today that the Swiss regulatory authority, Swissmedic, has granted approval for Duodart®, a fixed dose combination (FDC) of dutasteride (0.5mg) and tamsulosin (0.4mg).
2010-03-02	Impax Laboratories, LLC	Regulatory Impax Laboratories Receives Final FDA Approval for Generic FLOMAX(R) 0.4mg Capsules and Immediately Commences Shipment amneal.com ↗ We are pleased to report the final approval of our ANDA and that we are immediately commencing nation-wide shipment of our generic to FLOMAX(R).
2009-10-12	GlaxoSmithKline	Results GSK’s Avodart® / tamsulosin combination showed benefits for men with prostate enlargement gsk.com ↗ GlaxoSmithKline (GSK) announced today that final results from a large, 4-year study showed that Avodart (dutasteride) and tamsulosin combination treatment reduced the risk of acute urinary retention (AUR) or Benign Prostatic Hyperplasia* (BPH)-related surgery and reduced the risk of BPH clinical progression more than tamsulosin alone**.
2009-10-05	Impax Laboratories, LLC	Regulatory Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX(R) 0.4mg Capsules amneal.com ↗
2009-09-29	Wockhardt	Regulatory Wockhardt receives US FDA approval for Prostate drug Tamsulosin capsules wockhardt.com ↗ Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing the 0.4mg capsules of Tamsulosin Hydrochloride, which is used for treating Benign Prostatic Hyperplasia (BPH or non-cancerous enlargement of prostate).
2009-09-25	Astellas Pharma Inc	Regulatory ASTELLAS ANNOUNCES EXTENSION OF MARKET EXCLUSIVITY IN THE US FOR FLOMAX® CAPSULES astellas.com ↗ Based upon this determination, an additional 6-month of pediatric exclusivity for FLOMAX has been granted.
2009-07-01	Astellas Pharma Inc	Regulatory ASTELLAS ANNOUNCES SUBMISSION OF PEDIATRIC DATA FOR FLOMAX® CAPSULES IN THE US astellas.com ↗ ASTELLAS ANNOUNCES SUBMISSION OF PEDIATRIC DATA FOR FLOMAX® CAPSULES IN THE US
2008-01-31	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces Tentative Approval Of Generic Flomax® Capsules tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Tamsulosin Hydrochloride Capsules, 0.4 mg.

All press releases naming this drug 30 releases

Date	Issuer	Release
2018-05-24	Astellas Pharma Inc	Addition of Mirabegron to Tamsulosin Demonstrates Superior Efficacy Compared to Placebo in Men with Overactive Bladder Symptoms astellas.com ↗
2018-03-22	Veru Inc.	FDA Grants Fee Waiver for Tamsulosin DRS New Drug Application verupharma.com ↗
2018-03-15	Hanmi Pharmaceutical Company Limited	<보도자료> 한미약품 ‘한미탐스0.4mg’ 3상 결과 SCI급 국제학술지 등재 hanmi.co.kr ↗
2017-11-13	Veru Inc.	Veru Announces Tamsulosin DRS Bioequivalence Clinical Trial Results verupharma.com ↗
2017-08-16	Hanmi Pharmaceutical Company Limited	<보도자료> 한미약품 ‘구구탐스’ 3상 임상 결과, 국제학술지 등재 hanmi.co.kr ↗
2017-05-18	Hanmi Pharmaceutical Company Limited	<보도자료> 한미약품 ‘구구탐스’ 3상 결과, 美 비뇨기과학회 구연발표 hanmi.co.kr ↗
2016-12-26	Hanmi Pharmaceutical Company Limited	<보도자료> 전립선비대증+발기부전 치료제 ‘구구탐스캡슐’ 출시 hanmi.co.kr ↗
2016-10-21	Hanmi Pharmaceutical Company Limited	<보도자료> ‘전립선비대증+발기부전’ 복합제 ‘구구탐스’ 허가 hanmi.co.kr ↗
2016-09-27	Hanmi Pharmaceutical Company Limited	<보도자료> ‘탐스로신·타다라필 복합제’ 3상 결과 세계성의학회 임상부문 최우수 연제상 선정 hanmi.co.kr ↗
2016-05-12	Hanmi Pharmaceutical Company Limited	<보도자료> ‘한미탐스0.4mg’ 임상결과, 美비뇨기과학회 발표 hanmi.co.kr ↗
2012-03-27	Astellas Pharma Inc	ASTELLAS FILES REGULATORY SUBMISSION FOR EC905 - A NEW FIXED DOSE COMBINATION TREATMENT FOR MALE LUTS astellas.com ↗
2012-02-07	Eli Lilly and Company	New Study Evaluates Cialis® in parallel with Tamsulosin in Men with Signs and Symptoms Suggestive of Benign Prostatic Hyperplasia lilly.com ↗
2010-07-16	Sun Pharmaceutical Industries, Inc.	Sun Pharma announces USFDA approval for generic Flomax® sunpharma.com ↗
2010-06-13	GlaxoSmithKline	FDA approves Jalyn™, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate gsk.com ↗
2010-04-28	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of Generic Flomax® tevapharm.com ↗
2010-03-30	GlaxoSmithKline	GSK receives European approval for Duodart® gsk.com ↗
2010-03-21	GlaxoSmithKline	GlaxoSmithKline announces Swiss approval of Duodart® gsk.com ↗
2010-03-02	Impax Laboratories, LLC	Impax Laboratories Receives Final FDA Approval for Generic FLOMAX(R) 0.4mg Capsules and Immediately Commences Shipment amneal.com ↗
2009-10-12	GlaxoSmithKline	GSK’s Avodart® / tamsulosin combination showed benefits for men with prostate enlargement gsk.com ↗
2009-10-07	Astellas Pharma Inc	Astellas and Boehringer Ingelheim Reach Settlement with Impax on FLOMAX® Patent Case astellas.com ↗
2009-10-07	Impax Laboratories, LLC	Impax Laboratories Settles Pending Litigation for FLOMAX(R) amneal.com ↗
2009-10-05	Impax Laboratories, LLC	Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX(R) 0.4mg Capsules amneal.com ↗
2009-09-29	Wockhardt	Wockhardt receives US FDA approval for Prostate drug Tamsulosin capsules wockhardt.com ↗
2009-09-25	Astellas Pharma Inc	ASTELLAS ANNOUNCES EXTENSION OF MARKET EXCLUSIVITY IN THE US FOR FLOMAX® CAPSULES astellas.com ↗
2009-07-01	Astellas Pharma Inc	ASTELLAS ANNOUNCES SUBMISSION OF PEDIATRIC DATA FOR FLOMAX® CAPSULES IN THE US astellas.com ↗
2008-07-22	Impax Laboratories, LLC	IMPAX Sued Based on ANDA for Generic Flomax ® amneal.com ↗
2008-01-31	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Tentative Approval Of Generic Flomax® Capsules tevapharm.com ↗
2005-11-29	Astellas Pharma Inc	Astellas Sues Toyo Pharmar and Aska Pharmaceutical for Infringement of Patent on Harnal Capsule astellas.com ↗
2005-06-10	Astellas Pharma Inc	The Orally Disintegrating Tablet "Harnal® D Tablet" for the Treatment of Functional Symptoms of Benign Prostatic Hyperplasia to be Available in Japan astellas.com ↗
2005-05-16	Astellas Pharma Inc	Astellas and Boehringer Filed Lawsuit against FLOMAX® Generic for Patent Infringement in the USA astellas.com ↗

Evidence & citations 52 cited values

Every value below carries the sentence it was read from. 236 sources stand behind the page.

Field	Value	Cited text
Known as	tamsulosin	“Tamsulosin (a selective α1A- and α1D-adrenoceptor antagonist) has a relaxing effect on the smooth muscle in the prostate, the neck of the bladder, and the distal ureter,...” NCT06124066 ↗ 216 “patients with a prostate size smaller than 40mL will be treated with 0.4 mg tamsulosin once daily, while patients with larger prostates will be treated with 0.4 mg tamsulosin...” NCT04245566 ↗ “On Day 1 of each of 3 periods, subjects are given a single dose of EC905 under three conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the...” NCT01953861 ↗ “Co-administration of dutasteride 0.5 mg capsule (Oblong, size 6, dull yellow capsules: Commercially available) and tamsulosin hydrochloride 0.2 mg tablet (White, round standard...” NCT02184585 ↗ “The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.” NCT01943487 ↗ “Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.” NCT07444385 ↗ “Continued medication that the patient had before the enrollment of this study (tamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks)” NCT00687388 ↗ “Subjects will receive Tamsulosin (0.4 mg daily) beginning 5 days prior to surgery and for the duration of the postoperative hospital stay (approximately 8-12 days)” NCT07174349 ↗ “Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01254071 ↗ “The dosages prostatic hyperplasia medication: dutasteride 0,5 MG x1 or finasteride 5 MG x1 or combination of dutasteride and tamsulosin 0,5/0,4 MG x1.” NCT06001619 ↗ “The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia” NCT02390882 ↗ Show 206 more sources
Known as	Alphacard mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Bazetham mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Contiflo xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Cositam xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Diffundox	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Faramsil	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Flectone xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Flomax	“The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is...” NCT00244309 ↗ 9 “Therefore, the goal of our study is to investigate whether Tamsulosin (Flomax) can be used to lower incidence of POUR in older men undergoing an oncological thoracic surgical procedure.” NCT05657990 ↗ “Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01471678 ↗ “Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01254071 ↗ “tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery.” NCT02486653 ↗ “Other names: Flomax” NCT04159077 ↗ NCT00209131 ↗ NCT02244255 ↗ NCT02244294 ↗ NCT03229889 ↗
Known as	Flomax mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Flomax relief mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Flomaxtra xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Flowmax	“Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate.” NCT00762424 ↗
Known as	Galebon	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	HanmiTams Capsule	“Tamsulosin (HanmiTams Capsule) 0.4mg” NCT04084197 ↗
Known as	Harnal	“Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01254071 ↗ 1 “Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01471678 ↗
Known as	Harnal D	“Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01471678 ↗ 3 “Tamsulosin (Harnal, Harnal D, Flomax) is an alpha-1-adrenoceptor blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia.” NCT01254071 ↗ “After a 28-30 days washout, the subjects will be brought in and be given 0.2mg tamsulosin as Harnal D tablet for 7 days with the morning meal.” NCT01957189 ↗ “tamsulosin hydrochloride 0.2-mg orally disintegrating tablet [Harnal D® ]” PMID 28800206 ↗ Aug 2017
Known as	Harnal D. 0.2mg	“The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe...” NCT01404637 ↗
Known as	HGP-0412	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	HIP1402	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02715401 ↗ 1 NCT02712411 ↗
Known as	IY002	“Drug: IY002(Tamsulosin)” NCT07322991 ↗
Known as	Losinate mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	LY-253351	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Maxtron	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Morvesin xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Omnic mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Omnic OCAS	“The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic...” NCT07156916 ↗ 3 “The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic...” NCT07146711 ↗ “Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands)” NCT07091669 ↗ “Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate.” NCT01953848 ↗
Known as	Pamsvax xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Petyme	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Pinexel pr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Prosurin xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	R-(-)-YM-12617	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Sandoz Tamsulosin	“Sandoz Tamsulosin, the study drug, is an alpha1-adrenergic blocking agent approved by Health Canada for men with bladder outlet obstruction symptoms associated with benign...” NCT05941806 ↗
Known as	Stronazon	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Tabphyn mr	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Tamfrex xl	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Tamsulin	“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	Tamsulon	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Tamsulosin HCl	“Tamsulosin HCl is extensively metabolized, with less than 10% of the dose excreted in the urine unchanged \[Harnal, 2009a; Harnal, 2009b; Flomax, 2009\].” NCT01254071 ↗ 8 “In Period 1, subjects are randomized to receive one of the two final combination tablet formulations of tamsulosin HCl and solifenacin succinate.” NCT01953848 ↗ “tamsulosin HCl 0.2 or 0.4 mg in the fed state with a high-fat meal, or tamsulosin HCl 0.4 mg in the fasted state” PMID 33425801 ↗ Nov 2020 “Tamsulosin HCl is extensively metabolized, with less than 10% of the dose excreted in the urine unchanged” NCT01471678 ↗ “Tamsulosin HCl controlled release capsules” NCT02245490 ↗ “tamsulosin HCl oral disintegrating tablet” NCT02509104 ↗ “Tamsulosin HCl/Tadalafil 0.2/5mg” NCT02615782 ↗ “Drug: Tamsulosin HCl” NCT02634489 ↗ “Drug: Tamsulosin HCl” NCT02169713 ↗
Known as	Tamsulosin Hydrochloride	“The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic...” NCT07156916 ↗ 30 “At the time of successful catheter removal (Day 0), participants are randomised 1:1 via a central interactive web-response system, using covariate-adaptive minimisation...” NCT07846579 ↗ “0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)” NCT04491526 ↗ “Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state” NCT00537654 ↗ “A Randomized, Single Dose, Open-label, Cross-over Study on Bioequivalence of Two Formulations of Tamsulosin Hydrochloride Prolonged Release Capsule” NCT02138773 ↗ “Participants in this arm will receive tamsulosin hydrochloride sustained-release capsules (0.2 mg) orally once daily at bedtime for 8 weeks.” NCT07357324 ↗ “Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate” NCT00457457 ↗ “pharmacokinetics (PKs) of 0.2 and 0.4 mg tamsulosin hydrochloride (HCl) in the fed versus the fasted state” PMID 33425801 ↗ Nov 2020 “tamsulosin hydrochloride 0.2 mg tablet (White, round standard convex tablet: Commercially available)” NCT02184585 ↗ “Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis” NCT03614052 ↗ “Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain)” NCT07091669 ↗ Show 20 more sources
Known as	Tamsulosin hydrochloride component of jalyn	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	tamsulosin hydrochloride/solifenacin succinate fixed dose combination	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01018511 ↗
Known as	TAMSULOSIN Mepha Ret Depocaps	“0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)” NCT04491526 ↗
Known as	Tamsulosina	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	Tamsulosine	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01604811 ↗ 1 NCT02121613 ↗
Known as	Tamurex	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	TOCAS	“tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet” NCT01018511 ↗
Known as	YM-12617-1	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Known as	YM-617	ChEMBL registry synonym — accepted as the source's own label CHEMBL836 ↗
Action	Inhibit	“Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate” NCT00457457 ↗
Modality	Other / unclassified	“α-blockers such as tamsulosin in relieving "stent symptoms"” NCT02095665 ↗
Route	Oral	“Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)” NCT00151567 ↗