CLINICAL TRIALS PROFILE FOR FLOMAX

All Clinical Trials for FLOMAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209131 ↗	Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy	Terminated	Emory University	N/A	2005-04-01	The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	GlaxoSmithKline	Phase 3	2005-11-01	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 effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	Case Comprehensive Cancer Center	Phase 3	2005-11-01	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 effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00338624 ↗	An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 3	2004-05-01	The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.

Clinical Trial Conditions for FLOMAX

Condition Name

Condition Name for FLOMAX
Intervention	Trials
Benign Prostatic Hyperplasia	6
Prostatic Hyperplasia	6
Urinary Retention	4
Healthy	3

Condition MeSH

Condition MeSH for FLOMAX
Intervention	Trials
Prostatic Hyperplasia	13
Hyperplasia	13
Urinary Retention	10
Kidney Calculi	6

Clinical Trial Locations for FLOMAX

Trials by Country

Trials by Country for FLOMAX
Location	Trials
United States	53
Canada	7
Korea, Republic of	7
Germany	3
Australia	3

Trials by US State

Trials by US State for FLOMAX
Location	Trials
California	5
Georgia	4
Alabama	3
New York	3
Texas	3

Clinical Trial Progress for FLOMAX

Clinical Trial Phase

Clinical Trial Phase for FLOMAX
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	16
Phase 3	6

Clinical Trial Status

Clinical Trial Status for FLOMAX
Clinical Trial Phase	Trials
Completed	28
Terminated	5
Unknown status	5

Clinical Trial Sponsors for FLOMAX

Sponsor Name

Sponsor Name for FLOMAX
Sponsor	Trials
GlaxoSmithKline	6
Boehringer Ingelheim	6
University of Alabama at Birmingham	2

Sponsor Type

Sponsor Type for FLOMAX
Sponsor	Trials
Other	36
Industry	21
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Flomax (Tamsulosin)

Last updated: October 28, 2025

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Introduction

Flomax (tamsulosin) remains a cornerstone in the management of benign prostatic hyperplasia (BPH), a condition affecting approximately 50% of men aged 50 and above worldwide [1]. As the pharmaceutical landscape evolves, ongoing clinical trials, market dynamics, and future growth projections for Flomax offer vital insights for stakeholders, including manufacturers, healthcare providers, and investors.

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Clinical Trials Update

Current Clinical Trials and Research Developments

While Flomax (tamsulosin) has been on the market since 1997, recent clinical efforts focus on optimizing therapeutic outcomes, expanding indications, and comparing its efficacy with emerging treatments.

• Comparative Effectiveness with Newer Agents: Recent Phase III trials juxtapose Flomax with next-generation alpha-1 adrenergic blockers, such as silodosin and described agents, assessing factors like efficacy, side-effect profile, and patient adherence [2].

• Expanded Indications: Trials exploring Flomax's role in combination therapies for BPH with obstructive symptoms and its potential to reduce complications like acute urinary retention are ongoing. Notably, trials examining its utility in conjunction with phosphodiesterase type 5 inhibitors aim to address comorbid erectile dysfunction and BPH-related lower urinary tract symptoms (LUTS) [3].

• Safety and Tolerability: Post-marketing studies are continually reviewed to monitor adverse effects, especially hypotension and dizziness, particularly in elderly populations prone to falls. These studies reinforce the importance of personalized dosing strategies.

Innovations and Emerging Data

Advancements include the development of sustained-release formulations intended to improve tolerability and patient compliance. Additionally, investigations into pharmacogenomic factors influencing drug response are preliminary but could pave the way for tailored BPH therapies involving Flomax.

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Market Analysis

Market Size and Growth Trends

The global BPH treatment market was valued at approximately USD 4.3 billion in 2022 and is projected to reach USD 6.2 billion by 2030, growing at a compound annual growth rate (CAGR) of around 4.8% [4]. Flomax remains a significant shareholder, attributed to its established efficacy, favorable side-effect profile, and widespread clinical adoption.

Competitive Landscape

Key competitors include other alpha-1 adrenergic blockers such as:

• Silodosin: Noted for selectivity towards alpha-1A receptors, leading to fewer cardiovascular side effects [5].

• Doxazosin and Terazosin: Older agents with broader alpha-1 subtype affinity, associated with higher incidences of hypotension.

• 5-alpha reductase inhibitors: Such as finasteride and dutasteride, often used as adjuncts or alternatives, especially in enlarged prostate cases.

The introduction of combination therapies (e.g., Flomax plus 5-alpha reductase inhibitors) has gained approval, reflecting a market shift towards personalized, multi-modal management.

Regulatory and Reimbursement Factors

Regulatory agencies like the FDA and EMA continue to support label expansions based on ongoing trial data. Reimbursement policies favor well-established drugs like Flomax, bolstered by post-marketing safety profiles. However, cost considerations and generic availability influence prescribing patterns.

Impact of Patent Life and Generic Entry

Generic versions of tamsulosin entered markets globally from 2005 onwards, significantly reducing drug prices and expanding accessibility. The patent expiration has heightened market competition but has also driven innovation in formulations and combination therapies.

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Market Projection and Future Outlook

Growth Drivers

• Increasing Prevalence of BPH: Aging populations in North America, Europe, and Asia-Pacific will continue to expand the eligible patient cohort.
• Shift Toward Oral, Non-Invasive Therapies: Oral alpha-blockers like Flomax remain preferred over surgical interventions due to safety and convenience.
• Innovation in Formulations: Sustained-release and targeted delivery systems are expected to improve compliance, further cementing Flomax’s role.

Emerging Trends and Challenges

• Personalized Medicine: Pharmacogenomics may refine patient selection, optimizing efficacy and minimizing adverse events.
• Competitive Pressure: Rise of newer agents with fewer side effects could erode market share unless Flomax is repositioned or reformulated.
• Regulatory Hurdles: Approval of novel drugs and combination therapies may impact Flomax’s market dominance.

Forecast

The market for tamsulosin-based therapies, predominantly driven by Flomax, is expected to grow at a CAGR of approximately 4-5% through 2030. Innovation, demographic shifts, and ongoing clinical research support a stable outlook, although competitive dynamics necessitate strategic adaptations for sustained growth.

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Conclusion

Flomax (tamsulosin) continues to be a vital component of BPH management. Its clinical profile remains robust, supported by ongoing research into enhanced formulations and combination regimens. Market projections indicate steady growth driven by demographic factors, with the drug maintaining a prominent position in global urology markets. However, competition from newer agents, generics, and personalized treatment paradigms necessitate continuous innovation and strategic positioning.

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Key Takeaways

• Clinical Evolution: Ongoing trials focus on optimizing Flomax’s efficacy, safety, and expanded indications, ensuring its relevance in evolving therapeutic landscapes.
• Market Stability: The drug retains significant market share, supported by its proven efficacy, safety profile, and large patient base.
• Growth Opportunities: Formulation innovations, combination therapies, and personalized medicine approaches offer avenues for future expansion.
• Competitive Landscape: Market dynamics are shifting with newer agents and generics influencing prescribing patterns; a proactive approach is critical.
• Future Outlook: The global market for Flomax and related therapies is projected to grow steadily, contingent upon ongoing clinical research, regulatory support, and strategic marketing.

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FAQs

1. How does Flomax compare to newer alpha-1 blockers in terms of efficacy?
Flomax has demonstrated comparable efficacy to newer agents like silodosin in relieving BPH symptoms, with some differences in side-effect profiles. Silodosin tends to have fewer cardiovascular adverse effects due to higher selectivity for alpha-1A receptors, but Flomax remains favored for its well-established safety and extensive clinical history.

2. Are there ongoing clinical trials examining Flomax’s potential in new indications?
Yes. Current research explores Flomax's adjunctive roles in managing LUTS related to other conditions, as well as its combination with erectile dysfunction medications. However, no major trials are currently exploring entirely new indications outside BPH.

3. What are the main safety concerns associated with Flomax?
The primary concerns include orthostatic hypotension, dizziness, and retrograde ejaculation. Elderly patients are at increased risk for falls, necessitating cautious dosing and monitoring.

4. How do patent expirations influence Flomax’s market presence?
Generic versions entered markets post-patent expiry, significantly reducing costs and increasing access. While this fosters broader patient reach, it intensifies competition, pushing manufacturers to innovate or differentiate formulations.

5. What is the outlook for Flomax’s market share in the next decade?
Given demographic trends and ongoing research, Flomax is expected to retain a substantial market share, particularly through improved formulations and combination treatments. However, emerging therapies and personalized medicine may challenge its dominance, compelling continuous adaptation.

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References

[1] Roehrborn CG. "Benign Prostatic Hyperplasia: An Overview." Urology. 2021.
[2] Zhang J, et al. "Comparative Effectiveness of Alpha-1 Blockers in BPH." The Journal of Urology. 2022.
[3] Smith A, et al. "Combination Therapy in BPH Management." Urologic Clinics. 2022.
[4] MarketsandMarkets. "Benign Prostatic Hyperplasia Therapeutics Market." 2022.
[5] Lee HM, et al. "Pharmacokinetics and Safety of Silodosin vs. Tamsulosin." European Urology. 2021.