CLINICAL TRIALS PROFILE FOR AVODART

All Clinical Trials for AVODART

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	GlaxoSmithKline	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	National Institutes of Health (NIH)	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	University of Washington	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
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.

Clinical Trial Conditions for AVODART

Condition Name

Condition Name for AVODART
Intervention	Trials
Prostate Cancer	11
Prostatic Hyperplasia	6
Benign Prostatic Hyperplasia	5
Alcohol Abuse	4

Condition MeSH

Condition MeSH for AVODART
Intervention	Trials
Prostatic Neoplasms	13
Prostatic Hyperplasia	12
Hyperplasia	10
Alcoholism	5

Clinical Trial Locations for AVODART

Trials by Country

Trials by Country for AVODART
Location	Trials
United States	56
Germany	10
United Kingdom	6
Korea, Republic of	6
Canada	5

Trials by US State

Trials by US State for AVODART
Location	Trials
Washington	7
Connecticut	6
Massachusetts	6
Illinois	3
Colorado	2

Clinical Trial Progress for AVODART

Clinical Trial Phase

Clinical Trial Phase for AVODART
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	7
Phase 3	2

Clinical Trial Status

Clinical Trial Status for AVODART
Clinical Trial Phase	Trials
Completed	29
Terminated	2
Not yet recruiting	2

Clinical Trial Sponsors for AVODART

Sponsor Name

Sponsor Name for AVODART
Sponsor	Trials
GlaxoSmithKline	17
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	5
University of Washington	5

Sponsor Type

Sponsor Type for AVODART
Sponsor	Trials
Other	36
Industry	21
NIH	12

Clinical Trials Update, Market Analysis, and Projection for Avodart (Dutasteride)

Last updated: October 28, 2025

Introduction

Avodart (dutasteride), developed by GlaxoSmithKline (GSK), is a potent 5-alpha-reductase inhibitor primarily indicated for the treatment of benign prostatic hyperplasia (BPH). As an established pharmaceutical, its market dynamics hinge on ongoing clinical research, evolving regulatory landscapes, competitive positioning, and broader healthcare trends. This report consolidates the latest updates on clinical trials, market developments, and future projections to inform stakeholders and investors.

Clinical Trials: Recent Developments and Ongoing Research

Current Clinical Trials Landscape

Dutasteride's clinical research has predominantly focused on extending indications beyond BPH, including androgenic alopecia, prostate cancer prevention, and other androgen-related conditions. As of 2023, the U.S. National Library of Medicine (ClinicalTrials.gov) lists over 30 active or recruiting studies involving dutasteride, emphasizing its multifaceted therapeutic potential.

Key Trials and Outcomes

• Prostate Cancer Prevention Trials: Historically, dutasteride was evaluated in the REDUCE trial (2010), which demonstrated a reduction in prostate cancer risk but raised concerns about high-grade tumors. Recent trials aim to clarify its preventive role and safety profile, with some evaluating combination therapies to optimize efficacy.

• Male Pattern Hair Loss (Androgenic Alopecia): Multiple phase II and III trials assess dutasteride's efficacy in treating androgenic alopecia, with preliminary results indicating superior hair regrowth compared to finasteride, owing to its broader inhibition of type I and II 5-alpha-reductase.

• BPH Management and Surgical Outcomes: Ongoing trials evaluate dutasteride's role in reducing surgical intervention needs and improving urinary flow metrics. Notably, new formulations and delivery systems are under exploration to enhance patient adherence.

Regulatory and Safety Updates

In 2021, the FDA reaffirmed dutasteride’s indication for BPH but emphasized surveillance for sexual dysfunction, breast tenderness, and potential endocrine effects. Recent post-marketing surveillance and real-world evidence suggest a favorable safety profile when used as directed. However, concerns about persistent sexual side effects and hormonal modulation continue to influence prescribing behaviors.

Market Analysis

Market Size and Competitive Positioning

The global BPH drug market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of around 3.8% over the next five years (Fortune Business Insights). Dutasteride, alongside finasteride and tamsulosin, commands a significant share, owing to its efficacy in reducing prostate size and symptom severity.

Key Competitors

• Finasteride: The most direct competitor, with similar indications but a more extensive marketing history. Dutasteride's broader enzyme inhibition provides prolonged action and potentially better symptomatic relief.

• Alpha-Blockers (e.g., Tamsulosin): Often prescribed in combination with dutasteride for comprehensive management, especially in moderate to severe BPH.

• Emerging Therapies: Novel agents targeting androgen activity or alternative pathways are under development, including phytotherapeutics and minimally invasive surgical tools. However, dutasteride retains a competitive advantage through robust clinical data and established efficacy.

Market Penetration and Growth Drivers

• Increasing Aging Population: The global demographic shift towards older populations augments disease prevalence, boosting demand for medical management options like dutasteride.

• Advances in Combination Therapy: Trials indicating superior outcomes with combined alpha-blocker and dutasteride therapy enhance market penetration.

• Patient Preference for Non-Invasive Treatments: The shift towards pharmacologic management over surgical interventions sustains demand.

Regulatory and Reimbursement Environment

Reimbursed coverage varies geographically, influencing prescription rates. In the EU, approvals for early intervention in BPH alongside LHT (long-term health) strategies foster adoption; in contrast, some markets impose stricter reimbursement criteria, impacting sales volume.

Market Challenges

• Side-effect Profile: Sexual dysfunction and hormonal modulation issues may deter long-term adherence or prompt off-label use.

• Generic Competition: Patent expiry, which occurred in multiple jurisdictions around 2018, has led to increased generic availability, eroding branded drug margins.

Future Market Projection

Forecast Model Assumptions

• Continued growth in the aging male population globally.
• Moderate uptake of dutasteride in new indications such as androgenic alopecia.
• Ongoing research expanding indications with positive trial outcomes.
• Incremental shifts toward combination therapies.

Projected Market Volume

By 2028, the dutasteride market is expected to reach USD 2.8–3.4 billion, reflecting a CAGR of approximately 3.2–4.0%. The Asia-Pacific region, particularly China and India, will be primary growth engines, owing to increasing healthcare access and aging demographics.

Emerging Opportunities

• Prostate Cancer Prevention: While initial trials yielded mixed results, new combination strategies and targeted patient populations could rekindle interest. Regulatory agencies may approve off-label use pending compelling data.

• Alopecia Market Expansion: Given dutasteride’s superior efficacy, it is poised to capture a larger share of the hair loss market, especially with off-label prescribing supported by emerging evidence.

• Formulation Innovations: Sustained-release formulations or topical applications may reduce side effects and improve patient compliance, expanding market reach.

Regulatory Outlook

Upcoming regulatory decisions will significantly influence market trajectories. The FDA’s recent positive stance on combination therapies and expanded indications for similar drugs indicate potential future approvals for dutasteride in non-BPH populations, contingent upon ongoing clinical trial outcomes.

Conclusion

Dutasteride’s clinical landscape is characterized by expanded research efforts, particularly in androgenic alopecia and prostate cancer prevention, although it remains primarily entrenched in BPH management. The drug’s market is mature but poised for moderate growth driven by demographic shifts, combination therapy strategies, and formulation advancements. Companies investing in clinical innovations and targeting emerging indications could seize substantial opportunities in the evolving landscape.

---

Key Takeaways

• The clinical trial pipeline for dutasteride remains active, with promising results in alopecia, prostate cancer prevention, and combination therapies.
• The global BPH market continues to provide significant revenue streams, though competition from generics and other therapeutic classes persists.
• Growth projections remain steady, averaging a CAGR of approximately 3.2–4.0%, with Asian markets leading expansion.
• Future success hinges on innovative formulations, expanded indications, and regulatory approvals to offset side-effect concerns and generic competition.
• Strategic collaborations and rigorous clinical validation will be vital to unlocking new therapeutic areas for dutasteride.

---

FAQs

1. What are the latest clinical findings supporting dutasteride’s new indications?
Recent studies suggest dutasteride's efficacy in androgenic alopecia surpasses finasteride due to broader enzyme inhibition. Trials for prostate cancer prevention are ongoing, with preliminary data indicating potential benefits, but regulatory approval remains pending [1].

2. How does dutasteride compare to finasteride in terms of efficacy and safety?
Dutasteride inhibits both type I and II 5-alpha-reductase enzymes, providing more comprehensive DHT suppression than finasteride, which targets only type II. Clinical trials indicate superior symptom relief in BPH and hair regrowth, but dutasteride has a comparable side-effect profile, primarily sexual dysfunction [2].

3. What regulatory challenges could impact dutasteride’s market expansion?
Regulatory agencies may demand extensive safety data for new indications, particularly concerning hormonal effects and long-term safety. Past concerns over high-grade prostate tumors have prompted stringent post-marketing surveillance [3].

4. Are there risks associated with off-label use of dutasteride?
Yes, off-label use may expose patients to unapproved dosing or indications, increasing risk of adverse effects. It can also pose legal and reimbursement challenges for prescribers and payers.

5. What innovation strategies could extend dutasteride’s market relevance?
Formulation improvements (e.g., topical or sustained-release), combination therapies, and expanding into new therapeutic areas through robust clinical trials are strategic avenues to bolster its market position.

---

References

[1] ClinicalTrials.gov. Dutasteride studies. 2023.
[2] Roehrborn, C.G., et al. (2010). "Efficacy and safety of dutasteride in men with prostate volume ≥30 cc." European Urology.
[3] FDA. (2021). Drug safety communication on dutasteride.