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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR ALFUZOSIN HYDROCHLORIDE


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505(b)(2) Clinical Trials for alfuzosin hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Formulation NCT00280605 ↗ ALF-ONE : ALFuzosin ONcE Daily Completed Sanofi Phase 4 2005-08-01 The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
New Formulation NCT00542165 ↗ Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy Completed Sanofi Phase 4 2004-03-01 To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for alfuzosin hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00064649 ↗ Minimally Invasive Surgical Therapy for BPH Terminated Diagnostic Ultrasound Phase 3 2004-04-01 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00064649 ↗ Minimally Invasive Surgical Therapy for BPH Terminated Medtronic Phase 3 2004-04-01 The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
NCT00029822 ↗ Clinical Trial in Males With BPH (Enlarged Prostate) Completed Sanofi Phase 3 2001-05-01 A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. - Free study-related medical care provided.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for alfuzosin hydrochloride

Condition Name

99300123456789Benign Prostatic HyperplasiaProstatic HyperplasiaHealthy[disabled in preview]
Condition Name for alfuzosin hydrochloride
Intervention Trials
Benign Prostatic Hyperplasia 9
Prostatic Hyperplasia 9
Healthy 3
[disabled in preview] 0
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Condition MeSH

2019100-20246810121416182022Prostatic HyperplasiaHyperplasiaLower Urinary Tract Symptoms[disabled in preview]
Condition MeSH for alfuzosin hydrochloride
Intervention Trials
Prostatic Hyperplasia 20
Hyperplasia 19
Lower Urinary Tract Symptoms 10
[disabled in preview] 0
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Clinical Trial Locations for alfuzosin hydrochloride

Trials by Country

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Trials by Country for alfuzosin hydrochloride
Location Trials
United States 46
Canada 6
Korea, Republic of 6
India 4
Japan 3
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Trials by US State

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Trials by US State for alfuzosin hydrochloride
Location Trials
Minnesota 3
Wisconsin 3
Pennsylvania 3
New York 3
Massachusetts 3
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Clinical Trial Progress for alfuzosin hydrochloride

Clinical Trial Phase

40.0%56.7%0024681012141618Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for alfuzosin hydrochloride
Clinical Trial Phase Trials
Phase 4 12
Phase 3 17
Phase 2/Phase 3 1
[disabled in preview] 0
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Clinical Trial Status

72.5%15.0%12.5%0051015202530CompletedUnknown statusTerminated[disabled in preview]
Clinical Trial Status for alfuzosin hydrochloride
Clinical Trial Phase Trials
Completed 29
Unknown status 6
Terminated 5
[disabled in preview] 0
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Clinical Trial Sponsors for alfuzosin hydrochloride

Sponsor Name

trials02468101214161820222426SanofiSamsung Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)[disabled in preview]
Sponsor Name for alfuzosin hydrochloride
Sponsor Trials
Sanofi 25
Samsung Medical Center 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 4
[disabled in preview] 0
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Sponsor Type

56.1%36.4%7.6%00510152025303540IndustryOtherNIH[disabled in preview]
Sponsor Type for alfuzosin hydrochloride
Sponsor Trials
Industry 37
Other 24
NIH 5
[disabled in preview] 0
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Alfuzosin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Alfuzosin hydrochloride is an alpha-1 adrenergic blocker widely used in the symptomatic treatment of benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS). Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Mechanism of Action

Alfuzosin works by selectively binding to and inhibiting alpha-1 adrenergic receptors in the lower urinary tract, leading to the relaxation of smooth muscle in the prostate and bladder neck. This action improves urine flow and reduces urinary symptoms in patients with BPH[1].

Comparative Studies

A prospective study comparing alfuzosin (10 mg once daily) with tamsulosin (0.4 mg once daily) in patients with LUTS due to BPH showed that both medications significantly improved uroflowmetry results, quality of life scores, and International Prostate Symptom Scores (IPSS). There were no significant differences in efficacy between the two groups, and both medications were well tolerated with similar adverse event profiles[4].

Safety Profile

Clinical trials have consistently shown that alfuzosin is well tolerated. Common adverse effects include dizziness, headache, and asthenia, but these are generally mild and do not lead to treatment discontinuation. In the comparative study with tamsulosin, the only significant difference was the incidence of abnormal ejaculation, which was more common in the tamsulosin group[4].

Market Analysis

Current Market Size

The global alfuzosin market was valued at USD 0.5 billion in 2023. This market is segmented based on type (alfuzosin tablets and extended-release tablets) and application (BPH treatment and LUTS management), as well as geographical regions[3].

Market Drivers

Several factors are driving the growth of the alfuzosin market:

  • Aging Population: The increasing prevalence of BPH and LUTS in older populations is a significant driver.
  • Improvements in Urological Care: Advances in diagnostic methods and patient education are leading to earlier diagnosis and treatment initiation.
  • Patient Compliance: The preference for oral, non-invasive therapies among patients and healthcare practitioners contributes to market growth.
  • Research and Development: Ongoing research into combination therapies and personalized medicine is expected to further expand the market[3].

Market Projections

Growth Rate and Future Value

The alfuzosin market is projected to grow at a compound annual growth rate (CAGR) of 4% from 2024 to 2031, reaching a value of USD 0.68 billion by 2031. This growth is driven by the increasing demand for effective treatments for BPH and LUTS, as well as expanding healthcare access globally[3].

Geographical Trends

The market is expected to see significant growth in regions such as North America, Europe, and the Asia-Pacific, driven by the aging population and improvements in healthcare infrastructure. The Middle East and Africa are also expected to contribute to the market growth due to increasing awareness and access to urological care[3].

Regulatory and Approval Landscape

FDA Approval

Alfuzosin was initially approved by the FDA in 2003 for the symptomatic treatment of BPH. It is marketed under brand names such as Uroxatral and Xatral[1].

Global Approvals

The medication has received regulatory approvals in various regions, facilitating its widespread use. Continuous regulatory support and approvals in new areas are expected to further boost the market[3].

Patient Impact and Quality of Life

Symptom Improvement

Alfuzosin significantly improves urinary symptoms such as urgency, frequency, and changes to urine flow. It also enhances the quality of life for patients with BPH by reducing IPSS scores and improving uroflowmetry results[4].

Patient Compliance

The once-daily dosing regimen of alfuzosin, particularly with the extended-release formulation, enhances patient compliance. This sustained release over 20 hours helps in maintaining steady-state plasma concentrations, ensuring consistent therapeutic effects[1].

Adverse Effects and Safety Considerations

Common Adverse Effects

While alfuzosin is generally well tolerated, common adverse effects include dizziness, headache, and asthenia. These effects are typically mild and do not necessitate treatment discontinuation[4].

Special Precautions

Patients with renal insufficiency should be cautious, as alfuzosin clearance is increased in such cases. Additionally, the medication should be used with caution in patients over 75 years of age due to higher peak plasma levels[1].

Conclusion

Alfuzosin hydrochloride is a highly effective medication for the symptomatic treatment of BPH and associated LUTS. Clinical trials have demonstrated its efficacy and safety profile, which aligns with its widespread adoption in urological care. The market for alfuzosin is expected to grow significantly due to the aging population, improvements in healthcare, and ongoing research into combination therapies.

Key Takeaways

  • Alfuzosin hydrochloride is an alpha-1 adrenergic blocker used to treat BPH and LUTS.
  • Clinical trials show it is as effective as tamsulosin in improving urinary symptoms.
  • The global alfuzosin market is projected to reach USD 0.68 billion by 2031.
  • Market growth is driven by the aging population, improvements in urological care, and patient compliance.
  • Alfuzosin improves quality of life by reducing IPSS scores and enhancing uroflowmetry results.

FAQs

What is alfuzosin hydrochloride used for?

Alfuzosin hydrochloride is used in the symptomatic treatment of benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS)[1].

How does alfuzosin work?

Alfuzosin works by selectively binding to and inhibiting alpha-1 adrenergic receptors in the lower urinary tract, leading to the relaxation of smooth muscle in the prostate and bladder neck[1].

What are the common adverse effects of alfuzosin?

Common adverse effects include dizziness, headache, and asthenia. These effects are typically mild and do not necessitate treatment discontinuation[4].

How is alfuzosin administered?

Alfuzosin is available in both immediate-release and extended-release formulations. The extended-release formulation provides sustained release over 20 hours, ensuring steady-state plasma concentrations[1].

What is the projected market size of alfuzosin by 2031?

The global alfuzosin market is projected to reach USD 0.68 billion by 2031, growing at a CAGR of 4% from 2024 to 2031[3].

What factors are driving the growth of the alfuzosin market?

The growth is driven by the aging population, improvements in urological care, patient compliance with oral therapies, and ongoing research into combination therapies and personalized medicine[3].

Sources

  1. DrugBank Online: Alfuzosin: Uses, Interactions, Mechanism of Action.
  2. News Channel Nebraska: Alfuzosin Hydrochloride Tablets Market Size Insights & Predictive Forecasting Report to 2032.
  3. Market Research Intellect: Alfuzosin Market Size and Projections.
  4. UroToday: Comparison of Alfuzosin and Tamsulosin Once Daily for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

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