TheraRadar
Data updated: May 26, 2026

TAMSULOSIN HYDROCHLORIDE

Trial Activity: Mature 9 active trials
Urology Approved 2010-03-02

Tamsulosin hydrochloride helps patients with the signs and symptoms of benign prostatic hyperplasia (BPH). This medication is used to improve urine flow and reduce the urinary discomfort associated with an enlarged prostate. While it targets receptors that can affect muscle tone, it is not used to manage hypertension.

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Safety Patents

How TAMSULOSIN HYDROCHLORIDE Works

This drug works by blocking alpha 1 adrenoceptors, specifically the alpha 1A subtype concentrated in the human prostate and bladder neck. Binding to these receptors causes the smooth muscles in the prostate and bladder outlet to relax. This relaxation reduces the constriction of the bladder outlet, which improves urine flow and relieves obstructive symptoms.

Source: FDA Label

Development Insights

Mansoura University conducting 3 trials (6%)
51 indications explored (Broad Platform)
→ benign prostatic hyperplasia (7 trials)
→ lower urinary tract symptoms (7 trials)
→ urinary retention (4 trials)
10
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2010-03-02
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Sun Pharma PH HEALTH IMPAX LABS Aurobindo Pharma Novartis ZYDUS PHARMS USA INC SYNTHON BV SCIEGEN PHARMS CHARTWELL RX ASCENT PHARMS INC MACLEODS PHARMS LTD ALKEM LABS LTD PHARMOBEDIENT Teva RISING
Active Ingredient: TAMSULOSIN HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
54 FDA actions from 2010 to 2025
Nov 2025 SUPPL
Mfg · Manufacturing (CMC)
Sep 2025 SUPPL
Label · Labeling
May 2025 ORIGINAL
Update

What TAMSULOSIN HYDROCHLORIDE Treats

1 indications

TAMSULOSIN HYDROCHLORIDE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Benign prostatic hyperplasia (BPH)
Source: FDA Label

TAMSULOSIN HYDROCHLORIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

GEMTESA
SUMITOMO PHARMA
2020 2 indic.
TADALAFIL
NORVIUM BIOSCIENCE
2018 2 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

60 trials
Trial Sponsor ID Phase Status Title
NCT06257576 FOLI STUDY00006810 2025P010592 Ph 3 completed Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter
NCT04147806 PROSINT 2016-6545 Ph 1 active not recruiting A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer
NCT04597372 IRB00264995 Ph 2 recruiting Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
NCT07467343 FMASU MS 151/2026 Ph 4 not yet recruiting Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial
NCT07310797 14-IRB074 TCRD-TPE-115-35 Ph 4 not yet recruiting Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
NCT05753670 results posted EH22-470 Ph 3 completed Effect of Preoperative Tamsulosin on Postoperative Urinary Retention
NCT06966804 TRAM NMRR-24-03594-URB RSCH ID-24-05599-H07 Ph 3 recruiting Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
NCT03808155 GR20192021 Ph 4 completed Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty
NCT05415748 PERSONAL results posted 19-28557 K12DK111028 Ph 4 completed Deprescribing Tamsulosin in Older Men
NCT07114848 0996-2024-LNH-ERC Ph 4 completed Comparing Tamsulosin and Solifenacin for Relieving Double J Stent Symptoms: Using the USSQ.
NCT06843538 24-108 Ph 3 recruiting Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
NCT05401032 TryptoBPH TryptoBPH 2024-519076-75-00, 2021-000946-16 Ph 2 recruiting Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.
NCT06754410 SVU.MED.URO016.4.23,5,638 Ph 3 completed Efficacy of Antihistamine Drugs as Medical Expulsive Therapy Alone or in Combination With Alpha Blockers: A Prospective Randomized Controlled Study
NCT06737016 Tamsulosin & PUV Ph 3 recruiting Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
NCT03750656 HyTa Stent results posted HSC 142994 Ph 4 terminated Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
NCT02757768 PLUS results posted 178-MA-1008 2015-004036-36 Ph 4 completed A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
NCT02656173 results posted 178-MA-3016 Ph 4 completed A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)
NCT04994431 POUR results posted H00018178 Ph 4 terminated Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin
NCT02038868 4901-CL-0201 Ph 2 completed A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
NCT06262048 PrePOURTS PrePOURTS Ph 2 recruiting Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
NCT01568918 results posted 11-006704 Ph 3 terminated Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
NCT04859660 results posted 2102483026 Ph 2 completed Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
NCT04682366 results posted IRB00070462 Ph 4 terminated The Effect of Tamsulosin on Postoperative Urinary Retention
NCT05890235 NMT18016S Ph 4 completed Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
NCT05818670 tadalafil vs tamsulosin in bph Ph 4 completed Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
NCT05790902 AFIU-2022-02 Ph 1 completed COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
NCT01203371 APS 001/2010 BRA10APS001 Ph 3 withdrawn Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
NCT02095665 SPAM SPAM Ph 4 completed Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
NCT05551221 NQTIPS TREC2022-17 Ph 4 recruiting The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
NCT02003742 NX1207-IT-CL 0414 Ph 3 terminated Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
NCT02919436 DRIPS results posted IRB #4742 Ph 4 completed Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
NCT03976934 1725 Ph 1, Ph 2 completed Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.
NCT03524339 results posted Tamsulosin for POUR Ph 2, Ph 3 completed Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
NCT04819828 CI-HRAEB-2008-009 Ph 4 completed Tamsulosin as Adjunctive Therapy After Extracorporeal Shock Wave Lithotripsy for Renal Stones
NCT02369744 results posted HN 4441 Ph 4 terminated Silodosin Versus Tamsulosin for Treatment of Ureteral Stones
NCT04434378 17-19 Ph 4 terminated Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair
NCT02573311 results posted 527.85 Ph 3 completed Actual Use Study of Tamsulosin in Men
NCT01726270 results posted 527.82 Ph 2 completed An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
NCT02034604 2013-02-043 Ph 4 completed Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
NCT04107896 No BSMMU/2017/9066 Ph 4 completed Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
NCT02486653 POUR results posted 2014-1494 Ph 3 completed Prevention of Post-operative Urinary Retention
NCT02958878 GenesysRMC Ph 4 completed Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair
NCT01741454 results posted 2017-0755 2012-0279 Ph 4 completed Treatment of Symptoms After Stent Placement for Urinary Tract Obstruction
NCT02518971 results posted HUM00087825 Ph 3 terminated Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
NCT00382265 STONE results posted RO1 DK71603 U01DK096037, U01DK071603 Ph 4 completed Tamsulosin for Urolithiasis in the Emergency Dept
NCT01534351 results posted 0906A-149 Ph 3 terminated Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
NCT01294592 CONDUCT results posted 114615 Ph 4 completed Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
NCT01457573 LUTS results posted Pro00006253 IRB# 0711-0124 Ph 4 completed Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
NCT01657851 116502 Ph 1 completed Bioequivalence - Duodart Against Avodart & Omnic
NCT01560091 HN 4378 Ph 3 withdrawn Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Showing 50 of 60 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TAMSULOSIN HYDROCHLORIDE FDA Label Details

Indications & Usage

TAMSULOSIN HYDROCHLORIDE is indicated for the treatment of Benign prostatic hyperplasia (BPH).

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Full clinical data, patents, trials, and competitive landscape for tamsulosin hydrochloride.

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Data Sources

FDA Approval: ANDA090931 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment