tamsulosin
Trade name: flomax
Approved
Apr 15, 1997
Tamsulosin, a sulfamoylphenethylamine-derivative alpha-adrenoceptor blocker with enhanced specificity for the alpha-adrenoceptors of the prostate, is commonly used to treat benign prostatic hyperplasia (BPH). The drug is commercially available in a racemic mixture of 2 isomers, and is pharmacologically related to doxazocin, prazosin, and terazosin. However, unlike these drugs, tamsulosin has a higher affinity for the alpha-1A- adrenergic receptors, which are located in vascular smooth muscle. Studies show that tamsulosin has about 12 times greater affinity for alpha-1 adrenergic receptors in the prostate than those in the aorta, which may result in a reduced incidence of adverse cardiovascular effects. Tamsulosin is sold under the trade name Flomax. — NCATS
Clinical trial activity
232 trials · 158 clinical orgs · 30 marketing orgs
Earliest trial started Sep 30, 1997 (NCT04552431)
Timeline
1990s
- Jan 1, 1997
Earliest Phase 2 Sponsor(trial)
- Apr 15, 1997
Sanofi-Aventis — Earliest FDA Approval
- Apr 15, 1997
Sanofi-Aventis — NDA Secondary Org
- Apr 15, 1997
Sanofi-Aventis — NDA Organization
- Apr 15, 1997
Sanofi — Marketing Organization
- Apr 15, 1997
Sanofi — NDA Secondary Org
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
2000s
- Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
2010s
- Mar 2, 2010
Impax Laboratories — Marketing Organization
- Apr 27, 2010
Mylan — Marketing Organization
- Apr 27, 2010
Sandoz — Marketing Organization
- Apr 27, 2010
Byondis — Marketing Organization
- Apr 27, 2010
Teva — Marketing Organization
- Apr 27, 2010
Wockhardt — Marketing Organization
- Apr 27, 2010
Novartis — Marketing Organization
- Apr 27, 2010
PHARMOBEDIENT — Marketing Organization
- Apr 27, 2010
Sciegen Pharmaceticals — Marketing Organization
- Jun 14, 2010
GlaxoSmithKline — Marketing Organization
- Jun 14, 2010
Woodward — NDA Secondary Org
- Jun 14, 2010
Waylis Therap — NDA Secondary Org
- Jul 15, 2010
Sun Pharmaceuticals — Marketing Organization
- Jan 4, 2013
Anchen Pharmaceuticals, Inc — Marketing Organization
- Jan 4, 2013
Par Pharmaceuticals — Marketing Organization
- Jan 4, 2013
PH HEALTH — Marketing Organization
- Apr 30, 2013
Aurobindo Pharma — Marketing Organization
- Nov 20, 2015
Actavis — Marketing Organization
- Nov 20, 2015
Allergan PLC (2015) — Marketing Organization
- Jan 20, 2017
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Jan 20, 2017
Neogen — Marketing Organization
- Aug 11, 2017
Alkem Labs Ltd — Marketing Organization
- May 24, 2018
Zydus Discovery DMCC — Marketing Organization
- Oct 17, 2019
Anbison Lab — Marketing Organization
- Oct 17, 2019
Chartwell Pharmaceuticals — Marketing Organization
2020s
- May 4, 2022
ACME Laboratories — Marketing Organization
- May 4, 2022
Ascent Pharmahealth — Marketing Organization
- May 1, 2025
Rising Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Adult · Phase 1
- Anesthesia, Epidural · Phase 3
- Arthropathy, Neurogenic · Phase 4
- Calculi · Phase 4
- Cardiovascular Diseases · Phase 1
- Cholinergic Antagonists · Phase 4
- Choroid Diseases · Phase 4
- Colorectal Surgery · Phase 3
- Depressive Disorder · Phase 1
- Drug Interactions · Phase 1
- Drugs, Investigational · Phase 1
- Erectile Dysfunction · Phase 3
- General Surgery · Phase 4
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 4
- Hernia · Phase 4
- Hernia, Inguinal · Phase 4
- Hyperplasia · Phase 3
- Hypertension · Phase 1
- Kidney Calculi · Phase 3
- Kidney Diseases · Phase 4
- Lower Urinary Tract Symptoms · Phase 4
- Macular Edema · Phase 1/Phase 2
- Male · Phase 1
- Neoplasms · Phase 3
- Nephrolithiasis · Phase 4
- Nocturia · Phase 4
- Pain · Phase 4
- Pelvic Organ Prolapse · Phase 2/Phase 3
- Pharmacokinetics · Phase 1
- Postoperative Complications · Phase 4
- Premature Ejaculation · Phase 3
- Prostatic Neoplasms · Phase 4
- Prostatitis · Phase 4
- Pupil Disorders · Phase 4
- Quality of Life · Phase 4
- Rectal Diseases · Phase 3
- Rectal Neoplasms · Phase 3
- Renal Colic · Phase 4
- Stents · Phase 4
- Tamsulosin · Phase 3
- Thoracic Diseases · Phase 4
- Thoracic Surgery · Phase 3
- Ureteral Calculi · Phase 4
- Ureteral Diseases · Phase 4
- Ureteral Obstruction · Phase 4
- Ureterolithiasis · Phase 4
- Urinary Bladder Neck Obstruction · Phase 2
- Urinary Bladder Neoplasms · Phase 4
- Urinary Bladder, Neurogenic · Phase 2/Phase 3
- Urinary Bladder, Overactive · Phase 4
- Urinary Calculi · Phase 4
- Urinary Catheterization · Phase 3
- Urinary Incontinence · Phase 4
- Urinary Incontinence, Stress · Phase 2/Phase 3
- Urinary Retention · Phase 4
- Urinary Tract Infections · Phase 4
- Urinary Tract Physiological Phenomena · Phase 4
- Urination Disorders · Phase 4
- Urolithiasis · Phase 4
- Urological Manifestations · Phase 3
- Urologic Diseases · Phase 3
Mechanism of action
- Adrenergic receptor alpha-1ANTAGONIST
Adrenergic receptor alpha-1 antagonist
Combination products
jalyn
with dutasteride
Approval history
- approvedApr 15, 1997
Chemistry & pharmacology
SMILES
CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1- Mol. weight
- 408.52 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL836 ↗
- WikipediaTamsulosin ↗
- NCATSG3P28OML5I ↗
- ChEMBLCHEMBL1200914 ↗
Also known as
- 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide
- 5-[2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxy-benzenesulfonamide
- 5-[2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxy-benzenesulfonamide
- 5-((2r)-2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxy-benzenesulfonamide
- alphacard mr
- asp4901
- bazetham mr
- contiflo xl
- cositam xl
- diffundox
- faramsil
- flectone xl
- flomax
- flomax
- flomax
- flomax
- flomax
- flomax mr
- flomax mr
- flomax relief mr
- flomaxtra xl
- flowmax
- flowmax
- galebon
- losinate mr
- ly-253351
- ly-253351
- ly 253352
- ly-253352
- ly-253352
- maxtron
- morvesin xl
- omnic mr
- pamsvax xl
- petyme
- pinexel pr
- prosurin xl
- (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide
- (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide
- r-(-)-ym-12617
- r-(-)-ym-12617
- stronazon
- tabphyn mr
- tamfrex xl
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosin
- tamsulosina
- tamsulosina
- tamsulosine
- tamsulosine
- tamsulosin hcl
- tamsulosin hcl
- tamsulosin hcl
- tamsulosin hydrochloride
- tamsulosin hydrochloride
- tamsulosin hydrochloride
- tamsulosin hydrochloride
- tamsulosin hydrochloride
- tamsulosin hydrochloride
- tamsulosinum
- tamsulosinum
- tamurex
- tansulosine
- ym-12617-1
- ym-12617-1
- ym 617
- ym-617
- ym-617
- ym-617
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06546735 | Phase 3 | Nov 30, 2026 | Eurofarma Laboratorios S.A. |
| NCT07276919 | Phase 4 | Feb 1, 2026 | Peking University, Shanxi Medical University |
| NCT07310797 | Phase 4 | Jan 1, 2026 | Tzu Chi University |
| NCT07308002 | Phase 4 | Jan 1, 2026 | Mansoura University |
| NCT07174349 | Phase 4 | Dec 1, 2025 | Mayo Clinic |
| NCT07156916 | Phase 1 | Sep 8, 2025 | Menarini Group, Yerevan State Medical University, Armenia |
| NCT07091669 | Phase 1 | Jun 16, 2025 | Menarini Group, Yerevan State Medical University, Armenia |
| NCT06966804 | Phase 3 | Jun 1, 2025 | Penang Medical College |
| NCT06865430 | N/A | Mar 4, 2025 | University of Ankara |
| NCT07146711 | Phase 1 | Mar 3, 2025 | Menarini Group |
| NCT06264414 | Phase 3 | Feb 28, 2025 | EMS S/A |
| NCT06843538 | Phase 3 | Feb 3, 2025 | TriHealth |
| NCT06803030 | Phase 3 | Feb 1, 2025 | Government of Nepal, NAMS Bir Hospital |
| NCT07307261 | N/A | Oct 10, 2024 | South Valley University |
| NCT06262048 | Phase 2 | Oct 1, 2024 | University of Western Ontario |
| NCT07114848 | Phase 4 | Jun 13, 2024 | Liaquat University of Medical & Health Sciences |
| NCT06867315 | N/A | May 29, 2024 | First People's Hospital of Hangzhou, Fujian Provincial Hospital, Jiao Tong University, University of Science and Technology of China, Zhejiang University |
| NCT06955533 | N/A | Apr 1, 2024 | Ain Shams University |
| NCT06257576 | Phase 3 | Feb 26, 2024 | Emory University |
| NCT05657990 | Early Phase 1 (Phase 1) | Dec 20, 2023 | Hackensack University Medical Center |
Organizations
Research & Development (158)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Astellas | For profit | 24 | 21 | 5 | 2005 |
| GlaxoSmithKline | For profit | 20 | 18 | 3 | 2003 |
| Boehringer Ingelheim | For profit | 18 | 17 | 4 | 1998 |
| Mansoura University | Academic/Hospital | 8 | 8 | 3 | 2013 |
| Chong Kun Dang Pharmaceutical | For profit | 7 | 7 | 2 | 2014 |
| Hanmi Pharmaceutical | For profit | 7 | 7 | 2 | 2014 |
| Seoul National University | Academic/Hospital | 6 | 2 | 3 | 2007 |
| Eli Lilly | For profit | 4 | 4 | 2 | 2007 |
| Jeil Pharmaceutical Co., Ltd. | For profit | 4 | 4 | 2 | 2014 |
| Sungkyunkwan University | Academic/Hospital | 4 | 4 | 2 | 2008 |
| Yonsei University | Academic/Hospital | 4 | 2 | 1 | 2012 |
| Case Western Reserve University | Academic/Hospital | 3 | 2 | 2 | 2005 |
| Chonbuk National University | Academic/Hospital | 3 | 0 | 1 | 2013 |
| Emory University | Academic/Hospital | 3 | 2 | 3 | 2005 |
| GL Pharm Tech Corporation | For profit | 3 | 2 | 2 | 2012 |
| Menarini Group | For profit | 3 | 3 | 1 | 2025 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 3 | 2 | 2 | 1997 |
| University of Alabama, Birmingham | Academic/Hospital | 3 | 2 | 3 | 2008 |
| University of Rochester | Academic/Hospital | 3 | 1 | 2 | 2005 |
| University of Ulsan | Academic/Hospital | 3 | 1 | 2 | 2010 |
Marketing (35)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACME Laboratories | For profit | MKTG | May 4, 2022 |
| Actavis | For profit | MKTG | Nov 20, 2015 |
| Alkem Labs Ltd | For profit | MKTG | Aug 11, 2017 |
| Allergan PLC (2015) | For profit | MKTG | Nov 20, 2015 |
| Anbison Lab | For profit | MKTG | Oct 17, 2019 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Jan 4, 2013 |
| Ascent Pharmahealth | For profit | MKTG | May 4, 2022 |
| Aurobindo Pharma | For profit | MKTG | Apr 30, 2013 |
| Aurobindo Pharma | For profit | SYN | Jul 18, 2024 |
| Byondis | For profit | MKTG | Apr 27, 2010 |
| Byondis | For profit | SYN | Apr 27, 2010 |
| Chartwell Pharmaceuticals | For profit | MKTG | Oct 17, 2019 |
| GlaxoSmithKline | For profit | MKTG | Jun 14, 2010 |
| Impax Laboratories | For profit | MKTG | Mar 2, 2010 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Jan 20, 2017 |
| Mylan | For profit | MKTG | Apr 27, 2010 |
| Neogen | For profit | MKTG | Jan 20, 2017 |
| Novartis | For profit | MKTG | Apr 27, 2010 |
| PH HEALTH | For profit | MKTG | Jan 4, 2013 |
| PHARMOBEDIENT | For profit | MKTG | Apr 27, 2010 |
| Par Pharmaceuticals | For profit | MKTG | Jan 4, 2013 |
| Rising Pharmaceuticals | For profit | MKTG | May 1, 2025 |
| Sandoz | For profit | MKTG | Apr 27, 2010 |
| Sanofi | For profit | MKTG | Apr 15, 1997 |
| Sanofi | For profit | NDA2 | Apr 15, 1997 |
| Sanofi-Aventis | For profit | NDA2 | Apr 15, 1997 |
| Sanofi-Aventis | For profit | NDA | Apr 15, 1997 |
| Sciegen Pharmaceticals | For profit | MKTG | Apr 27, 2010 |
| Sun Pharmaceuticals | For profit | MKTG | Jul 15, 2010 |
| Teva | For profit | MKTG | Apr 27, 2010 |
| Waylis Therap | For profit | NDA2 | Jun 14, 2010 |
| Wockhardt | For profit | MKTG | Apr 27, 2010 |
| Woodward | For profit | NDA2 | Jun 14, 2010 |
| Zydus Discovery DMCC | For profit | MKTG | May 24, 2018 |
| Zydus Discovery DMCC | For profit | SYN | Apr 27, 2010 |