CLINICAL TRIALS PROFILE FOR TAMSULOSIN HYDROCHLORIDE

505(b)(2) Clinical Trials for TAMSULOSIN HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT02573311 ↗	Actual Use Study of Tamsulosin in Men	Completed	Boehringer Ingelheim	Phase 3	2015-09-23	An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.
OTC	NCT01726270 ↗	An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms	Completed	Boehringer Ingelheim	Phase 2	2012-11-01	Multicenter trial conducted in Pharmacy retail centers

All Clinical Trials for TAMSULOSIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00201630 ↗	Prophylactic Vs. Therapeutic Use of Uroxatrol in Men Undergoing Brachytherapy	Unknown status	Sanofi	Phase 3	2005-09-01	To asess the efficacy of Uroxatrol, an alpha blocker in men undergoing prostate brachytherapy to treat prostate cancer, and whether the use of Uroxatrol in advance of the brachytherapy is better or not than starting it on the day of surgery.
NCT00147654 ↗	Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction	Completed	Pfizer	Phase 4	2004-11-01	The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).
NCT00147654 ↗	Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2004-11-01	The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).
NCT00090103 ↗	Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment	Completed	GlaxoSmithKline	Phase 3	2003-11-01	This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
NCT00151567 ↗	Evaluation of Tamsulosin in the Treatment of Ureteral Stones	Completed	Ministry of Health, France	Phase 3	2002-02-01	Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
NCT00151567 ↗	Evaluation of Tamsulosin in the Treatment of Ureteral Stones	Completed	Yamanouchi	Phase 3	2002-02-01	Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.
NCT00151567 ↗	Evaluation of Tamsulosin in the Treatment of Ureteral Stones	Completed	Rennes University Hospital	Phase 3	2002-02-01	Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.

Clinical Trial Conditions for TAMSULOSIN HYDROCHLORIDE

Condition Name

Condition Name for TAMSULOSIN HYDROCHLORIDE
Intervention	Trials
Benign Prostatic Hyperplasia	35
Prostatic Hyperplasia	30
Lower Urinary Tract Symptoms	17
Urinary Retention	15

Condition MeSH

Condition MeSH for TAMSULOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	79
Hyperplasia	76
Lower Urinary Tract Symptoms	30
Urinary Retention	26

Clinical Trial Locations for TAMSULOSIN HYDROCHLORIDE

Trials by Country

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−

Trials by Country for TAMSULOSIN HYDROCHLORIDE
Location	Trials
United States	219
Germany	42
Korea, Republic of	33
Italy	29
United Kingdom	25

Trials by US State

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−

Trials by US State for TAMSULOSIN HYDROCHLORIDE
Location	Trials
California	13
New York	11
Texas	10
Alabama	10
Ohio	9

Clinical Trial Progress for TAMSULOSIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for TAMSULOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	58
Phase 3	41
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for TAMSULOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	118
Unknown status	28
Recruiting	18

Clinical Trial Sponsors for TAMSULOSIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for TAMSULOSIN HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	20
Boehringer Ingelheim	20
Astellas Pharma Inc	13

Sponsor Type

Sponsor Type for TAMSULOSIN HYDROCHLORIDE
Sponsor	Trials
Other	139
Industry	113
NIH	5

Tamsulosin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Tamsulosin Hydrochloride

Tamsulosin hydrochloride is a selective α1A-adrenoceptor antagonist widely used for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Long-Term Efficacy and Safety

A significant study published in the Journal of Urology demonstrated the sustained efficacy and safety of tamsulosin over a period of up to 6 years. This multicenter open-label extension study involved 609 patients, with 159 having a 2-year or greater prior experience with tamsulosin, resulting in a potential 6-year experience. The study showed that initial improvements in maximum urine flow rate and American Urological Association symptom index were maintained throughout the study, with tamsulosin being well tolerated and having a low incidence of orthostatic hypotension (1.3%)[1].

Ongoing and Future Clinical Trials

Clinical trials continue to explore the efficacy and safety of tamsulosin in various contexts. For instance, a phase II trial is investigating whether prostatic artery embolization (PAE) combined with tamsulosin improves urinary symptoms in patients undergoing radiation therapy. This trial aims to assess the effectiveness of this combination in managing LUTS in a different patient population[5].

Market Analysis

Global Market Size and Growth

The global tamsulosin hydrochloride market has shown significant growth over the years. As of 2017, the market revenue had increased substantially from 2013, and it is projected to continue growing with a notable CAGR from 2018 to 2023. The market is expected to reach a substantial value by 2023, driven by increasing demand for treatments of BPH and LUTS[2].

Regional Market Dynamics

The market is segmented by region, with North America, Europe, China, Japan, and other areas contributing significantly. China, in particular, has seen rapid growth in the tamsulosin hydrochloride market, accounting for a significant percentage of the global market. North America and Europe are also key production regions, expected to maintain their growth rates in the coming years[3].

Competitive Landscape

The competitive landscape of the tamsulosin hydrochloride market is dominated by several key players, including Samex Overseas, Cerata Pharmaceuticals, MedicaPharma, Hema Pharmaceuticals Pvt. Ltd., and Jigs Chemical. These companies hold a significant share of the global market, with the top five players accounting for a substantial percentage of the market share in 2023[3].

Market Projections

Future Growth and Trends

The global tamsulosin hydrochloride API market is projected to expand at a considerable CAGR from 2024 to 2030. The market size is expected to reach a substantial value by 2030, driven by increasing demand for BPH treatments and the expanding use of tamsulosin in various formulations such as capsules and tablets[3].

Regional Growth Projections

North America and Europe are expected to maintain their positions as key production regions, while China is anticipated to continue its rapid growth. The market in these regions is forecasted to grow significantly, driven by demographic factors such as an aging population and increasing prevalence of BPH[3].

Key Applications and End-Use Industries

Tamsulosin hydrochloride is primarily used in the treatment of LUTS associated with BPH. The market is driven by significant applications in various end-use industries, including the production of capsules, tablets, and other pharmaceutical formulations. The expanding demands from these industries are propelling the growth of the tamsulosin hydrochloride API market[3].

Industry Development Environment

Market Drivers and Restraints

The tamsulosin hydrochloride market is driven by factors such as the increasing prevalence of BPH, an aging population, and advancements in pharmaceutical technology. However, the market also faces restraints, including regulatory challenges and competition from other BPH treatments. The industry trends and market drivers are expected to shape the future growth of the market[3].

SWOT Analysis

A SWOT analysis of the tamsulosin hydrochloride market reveals strengths such as the drug's efficacy and safety profile, opportunities like expanding demand in emerging markets, weaknesses such as potential side effects, and threats including competition from generic alternatives and regulatory changes[2][3].

Conclusion

Tamsulosin hydrochloride remains a vital treatment option for LUTS associated with BPH, with a strong clinical trials profile and a growing market. The drug's long-term efficacy and safety have been well established, and ongoing trials continue to explore its potential in different clinical contexts. The market is expected to grow significantly, driven by increasing demand and demographic factors.

Key Takeaways

• Long-term Efficacy: Tamsulosin hydrochloride has demonstrated sustained efficacy and safety over up to 6 years in treating LUTS associated with BPH.
• Market Growth: The global tamsulosin hydrochloride market is projected to grow with a notable CAGR from 2018 to 2023 and beyond.
• Regional Dynamics: North America, Europe, and China are key regions driving the market growth.
• Competitive Landscape: The market is dominated by several key players, including Samex Overseas and Cerata Pharmaceuticals.
• Future Projections: The market is expected to reach a substantial value by 2030, driven by increasing demand and demographic factors.

FAQs

What is the primary use of tamsulosin hydrochloride?

Tamsulosin hydrochloride is primarily used for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

What is the long-term safety and efficacy profile of tamsulosin hydrochloride?

Tamsulosin hydrochloride has been shown to be safe and effective over a period of up to 6 years, with initial improvements in symptoms and urine flow rates maintained throughout the study period[1].

Which regions are key players in the tamsulosin hydrochloride market?

North America, Europe, and China are the key regions driving the growth of the tamsulosin hydrochloride market[3].

Who are the major manufacturers of tamsulosin hydrochloride?

The major manufacturers include Samex Overseas, Cerata Pharmaceuticals, MedicaPharma, Hema Pharmaceuticals Pvt. Ltd., and Jigs Chemical[3].

What is the projected market size of tamsulosin hydrochloride by 2030?

The global tamsulosin hydrochloride API market is expected to reach a substantial value by 2030, driven by increasing demand and demographic factors[3].

Sources

1. Long-term Safety and Efficacy of Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. Journal of Urology, doi: 10.1097/01.ju.0000076140.68657.fd.
2. Global Tamsulosin Hydrochloride Industry Market Research Report. Maiaresearch.
3. Tamsulosin hydrochloride API Report 2024, Global Revenue, Key Companies Market Share & Rank. QYResearch.
4. CENTER FOR DRUG EVALUATION AND RESEARCH. FDA, 1996.
5. Clinical Trials Using Tamsulosin Hydrochloride. National Cancer Institute.