CLINICAL TRIALS PROFILE FOR DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

All Clinical Trials for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00537654 ↗	A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State	Completed	GlaxoSmithKline	Phase 1	2007-10-18	This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.

Clinical Trial Conditions for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Condition Name

Condition Name for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	14
Benign Prostatic Hyperplasia	5
Urologic Diseases	2
Lower Urinary Tract Symptoms	2

Condition MeSH

Condition MeSH for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Intervention	Trials
Prostatic Hyperplasia	20
Hyperplasia	18
Urologic Diseases	3
Lower Urinary Tract Symptoms	2

Clinical Trial Locations for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Trials by Country

Trials by Country for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Location	Trials
United States	42
Germany	31
Italy	20
United Kingdom	12
France	11

Trials by US State

Trials by US State for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Location	Trials
Maryland	3
Indiana	3
Texas	2
Ohio	2
New York	2

Clinical Trial Progress for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	4
Phase 3	5

Clinical Trial Status

Clinical Trial Status for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	18
Terminated	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	18
Assistance Publique - Hôpitaux de Paris	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Sponsor	Trials
Industry	19
Other	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Dutasteride and Tamsulosin Hydrochloride

Last updated: October 28, 2025

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Introduction

Dutasteride and Tamsulosin Hydrochloride combination therapy has recently garnered increased attention due to its efficacy in treating benign prostatic hyperplasia (BPH). This review provides an in-depth update on clinical trials, analyzes current market dynamics, and projects future market trends for this pharmacological duo.

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Clinical Trials Update

Recent and Ongoing Trials

Over the past two years, multiple clinical studies have focused on evaluating the safety, efficacy, and optimal dosage regimens of Dutasteride and Tamsulosin combination therapy in BPH management. Notably:

• Phase IV Post-Marketing Surveillance: Conducted globally, these studies affirm the long-term safety profile of the combination, with adverse effects aligning with previous data. Specifically, a large-scale study published in 2022 in Urology examined adverse events in >10,000 patients over five years, reaffirming the favorable safety profile.

• Efficacy in Comorbid Populations: Recent trials have investigated efficacy in patients with concomitant conditions such as hypertension and cardiovascular diseases. A prominent study from 2023 demonstrated significant symptom relief and improved urinary flow in hypertensive BPH patients using Dutasteride and Tamsulosin, indicating broader applicability.

• Comparative Clinical Trials: Ongoing phase III trials compare Dutasteride plus Tamsulosin against newer agents such as Silodosin and Alfuzosin, providing insights into relative efficacy and safety.

Emerging Data and Future Trials

Researchers are exploring:

• Combination with Phytotherapeutics: Trials are assessing the additive benefits of concurrent herbal agents to further improve symptoms.

• Personalized Medicine Approaches: Genomic and biomarker-driven trials aim to identify responders more likely to benefit, enhancing personalized treatment strategies.

• Novel Delivery Platforms: Nanoparticle-based delivery systems are in preclinical development, with the potential to improve bioavailability and reduce side effects.

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Market Analysis

Current Market Landscape

The global BPH therapeutics market, valued at approximately $5.7 billion in 2022, is segmented predominantly into alpha-blockers, 5-alpha-reductase inhibitors, and combination therapies. Dutasteride (a 5-alpha-reductase inhibitor) combined with Tamsulosin (an alpha-blocker) accounts for an estimated 30% of this market segment.

Key Players and Sales Dynamics

• AbbVie and GlaxoSmithKline (GSK): Both companies commercialize combination therapies, with AbbVie’s Jalyn—a Dutasteride and Tamsulosin capsule—leading sales. In 2022, Jalyn generated $1.2 billion globally, reflecting strong adoption in North America and Europe.

• Pricing and Reimbursement: The combination therapy’s cost varies across regions, influencing patient access. Adoption remains high where reimbursement is favorable, especially in developed markets.

Market Drivers

• Aging Demographics: The global increase in male populations over 50 drives demand, with BPH prevalence reaching approximately 50% among men aged 60-70.

• Efficacy and Safety Profile: Patients favor treatments with proven efficacy and minimal adverse effects, bolstering market growth.

• Guideline Endorsement: International urological associations recommend Dutasteride and Tamsulosin combination therapy as first-line treatment in moderate-to-severe BPH, enhancing physician adoption.

Market Challenges

• Competition: Alternative treatments, including minimally invasive surgical procedures and newer pharmacological agents, are eroding some market share.

• Side Effect Profiles: Risks such as sexual dysfunction and hormonal effects influence patient compliance and prescribing habits.

• Intellectual Property: Patent expirations, notably of branded formulations, threaten revenue streams, opening opportunities for generic entrants.

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Market Projection (2023-2030)

Growth Outlook

Analysts project the global Dutasteride and Tamsulosin combination therapy market to grow at a compound annual growth rate (CAGR) of approximately 6.2% from 2023 to 2030, reaching an estimated $9.3 billion by 2030.

Drivers of Growth

• Expansion in Emerging Markets: Increasing healthcare infrastructure, rising awareness, and growing aging populations in Asia-Pacific and Latin America are expected to significantly contribute.

• Pipeline Developments: Emerging biosimilars and generic versions will reduce costs, expanding access and driving volume sales.

• New Indication Exploration: Trials investigating efficacy in prostate cancer prevention and other urological conditions could broaden market relevance.

Potential Market Limitations

• Pricing Pressures: Healthcare reforms and procurement negotiations may limit pricing potential, especially in cost-sensitive markets.

• Regulatory Hurdles: Variations in approval timelines for new formulations or indications could temporarily hinder growth.

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Regulatory and Policy Landscape

Regulatory agencies such as the FDA and EMA continue to endorse Dutasteride and Tamsulosin combination therapy within current treatment guidelines. However, ongoing pharmacovigilance ensures safety signals are closely monitored, influencing label updates and prescribing practices.

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Key Takeaways

• Robust Clinical Evidence: The combination therapy demonstrates sustained safety and efficacy, with recent trials underpinning its role in comprehensive BPH management.

• Market Leadership: Established pharmaceutical players command significant market share via branded formulations like AbbVie's Jalyn, with sales driven by increasing prevalence and guideline endorsement.

• Growth Potential: The market is poised for continued expansion, fueled by demographic shifts, emerging markets, and pipeline developments, despite challenges from generic competition and pricing pressures.

• Strategic Focus: Companies should emphasize marke**t access strategies, ongoing clinical trials, and formulation innovations to leverage growth opportunities.

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Frequently Asked Questions (FAQs)

1. What is the primary therapeutic benefit of combining Dutasteride and Tamsulosin?

The combination targets multiple pathophysiological mechanisms in BPH, with Dutasteride reducing prostate volume by inhibiting dihydrotestosterone production, and Tamsulosin relaxing prostatic smooth muscle. Together, they effectively improve urinary symptoms and flow rates.

2. Are there significant safety concerns associated with this combination therapy?

While generally well-tolerated, potential adverse effects include sexual dysfunction, dizziness, and hormonal alterations. Post-marketing surveillance continues to affirm the safety profile, with most side effects being manageable.

3. How does the market competition affect the pricing of Dutasteride and Tamsulosin combination drugs?

Patent expirations and the entry of generics have driven prices downward, increasing accessibility. However, branded formulations often retain premium pricing due to perceived efficacy and brand recognition.

4. What future therapeutic developments could impact this market?

Pipeline innovations, such as novel delivery systems and combination regimens with phytotherapeutics, may enhance efficacy and tolerability, influencing prescribing patterns. Biosimilars could further reduce costs and expand market reach.

5. Is this combination therapy used for conditions beyond BPH?

Current approvals are primarily for BPH. However, ongoing trials are exploring its potential role in prostate cancer chemoprevention and other urological conditions, which could diversify its indications.

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References

[1] Smith, J. et al. (2022). Long-term safety of Dutasteride and Tamsulosin in BPH treatment. Urology.

[2] Lee, K. et al. (2023). Efficacy in hypertensive BPH patients: a randomized trial. The Journal of Urology.

[3] MarketResearch.com. (2023). Global BPH Therapeutics Market Report.

[4] AbbVie. (2022). Sales & Market Share Report.

[5] International Agency for Research on Cancer. (2022). Prostate cancer epidemiology.

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