CLINICAL TRIALS PROFILE FOR DUTASTERIDE

505(b)(2) Clinical Trials for dutasteride

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
New Formulation	NCT05599243 ↗	Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.	Recruiting	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Phase 2	2022-09-29	Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.

All Clinical Trials for dutasteride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00056407 ↗	"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk	Completed	GlaxoSmithKline	Phase 3	2003-03-01	This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
NCT00062790 ↗	Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels	Completed	GlaxoSmithKline	Phase 4	2003-10-01	This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
NCT00070733 ↗	The Effect of 5-Alpha Reductase on Testosterone in Men	Unknown status	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2003-08-01	The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle strength, and sexual function in men. This study will evaluate how 5-alpha reductase influences the effects of testosterone in young healthy men.
NCT00082043 ↗	Dutasteride to Treat Women With Menstrually Related Mood Disorders	Completed	National Institute of Mental Health (NIMH)	Phase 1	2004-03-31	This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men. Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up. Participants undergo the following tests and procedures: - Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2 months of placebo. Neither the participants nor the investigators know when the subject is taking the active medication or the placebo. - Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings. - Monthly follow-up visits: Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status.
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.
NCT00146146 ↗	Testosterone and Its Metabolites in GID	Completed	Schering-Plough	Phase 3	2005-05-01	The purposes of this study are: - to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile - to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile
NCT00146146 ↗	Testosterone and Its Metabolites in GID	Completed	Unita Complessa di Ostetricia e Ginecologia	Phase 3	2005-05-01	The purposes of this study are: - to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile - to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile

Clinical Trial Conditions for dutasteride

Condition Name

Condition Name for dutasteride
Intervention	Trials
Prostate Cancer	25
Prostatic Hyperplasia	22
Benign Prostatic Hyperplasia	20
Hypogonadism	6

Condition MeSH

Condition MeSH for dutasteride
Intervention	Trials
Prostatic Hyperplasia	48
Hyperplasia	43
Prostatic Neoplasms	32
Alopecia	10

Clinical Trial Locations for dutasteride

Trials by Country

Trials by Country for dutasteride
Location	Trials
United States	236
Germany	69
United Kingdom	51
Canada	35
Italy	31

Trials by US State

Trials by US State for dutasteride
Location	Trials
Washington	16
Massachusetts	14
Maryland	12
Illinois	10
California	10

Clinical Trial Progress for dutasteride

Clinical Trial Phase

Clinical Trial Phase for dutasteride
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	2
Phase 4	19

Clinical Trial Status

Clinical Trial Status for dutasteride
Clinical Trial Phase	Trials
Completed	84
Unknown status	7
Recruiting	6

Clinical Trial Sponsors for dutasteride

Sponsor Name

Sponsor Name for dutasteride
Sponsor	Trials
GlaxoSmithKline	58
University of Washington	7
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	5

Sponsor Type

Sponsor Type for dutasteride
Sponsor	Trials
Other	88
Industry	78
NIH	19

Dutasteride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Dutasteride, marketed primarily under the brand name Avodart, is a potent 5-alpha-reductase inhibitor primarily indicated for benign prostatic hyperplasia (BPH). Originally developed by GlaxoSmithKline, it inhibits the conversion of testosterone to dihydrotestosterone (DHT), a hormone linked to prostate growth. Its pharmacological profile has positioned it as a key drug in urology, but recent clinical trials, evolving market dynamics, and expanding therapeutic indications necessitate a comprehensive review for stakeholders.

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Clinical Trials Update

Recent clinical research on Dutasteride focuses on its expanding therapeutic scope beyond BPH, including androgenic alopecia and prostate cancer risk reduction.

1. Prostate Cancer Prevention and Detection

Multiple studies, including the REDUCE trial, have evaluated Dutasteride's role in reducing the incidence of prostate cancer. While initial findings suggested a decrease in overall prostate cancer risk, subsequent analyses raised concerns regarding higher incidences of high-grade tumors ([1]). Current trials are investigating:

• Long-term safety profiles concerning high-grade prostate carcinomas.
• Combination therapies with other agents to optimize benefits while mitigating risks.

2. Androgenic Alopecia

Dutasteride has gained prominence off-label for androgenic alopecia due to its superior DHT suppression compared to Finasteride ([2]). Recent phase III trials demonstrate:

• Significant hair density improvement in male patients.
• Favorable safety profiles, with low discontinuation rates.

3. Emerging Indications

Ongoing clinical trials aim to assess Dutasteride's potential role in:

• Male pattern baldness: Phase II trials report promising results, but further studies are required for regulatory approval.
• Benign prostatic disease management: Some studies suggest utility in reducing surgical interventions.

4. Safety and Pharmacovigilance

Recent meta-analyses emphasize the importance of monitoring adverse effects, such as:

• Sexual dysfunction
• Gynecomastia
• Possible mood alterations ([3]) While generally well-tolerated, long-term safety remains crucial for approval of expanded indications.

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Market Analysis

1. Current Market Landscape

Dutasteride's global market was valued at approximately USD 300 million in 2022, driven predominantly by BPH treatment. Major markets include North America, Europe, and parts of Asia-Pacific, with undisputed dominance by generics suppliers following patent expirations.

2. Competitive Positioning

• Finasteride is the primary competitor, primarily marketed as Proscar and Propecia. While Finasteride is approved for BPH and hair loss, compelling evidence suggests Dutasteride's superior potency in DHT suppression offers a competitive edge, especially in alopecia.
• Novel 5-alpha-reductase inhibitors, with unique molecular profiles, are entering development stages, potentially reshaping competitive dynamics.

3. Regulatory and Off-Label Use Trends

Regulatory agencies have approved Dutasteride for BPH globally, but off-label use for hair loss and possible prostate cancer risk reduction has driven increased demand. The off-label use, however, faces regulatory scrutiny and reimbursement challenges, especially in lower-income markets.

4. Patent Landscape & Market Entry Barriers

Dutasteride’s patent expired in key markets such as the U.S. and E.U., enabling generic manufacturers to compete. Patent litigations and patenting strategies for formulations or combinations remain critical for market share retention among innovator companies.

5. Future Market Drivers

• Rising prevalence of BPH and androgenic alopecia in aging populations.
• Developments in combination therapies (e.g., Dutasteride with alpha-blockers).
• Increasing awareness and research into Dutasteride’s potential in prostate cancer prevention.

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Market Projections

1. Growth Forecast (2023-2030)

The Dutasteride market is projected to grow at a CAGR of 4-6% over the next decade, reaching an estimated USD 500 million by 2030. The growth is primarily driven by:

• Aging populations globally.
• Expanding indications, particularly in dermatology and prostate health.
• Market penetration in emerging markets, such as Asia-Pacific and Latin America.

2. Regional Insights

• North America: Maintains leadership, with high adoption rates in BPH and off-label usage for hair loss.
• Europe: Stable growth, moderated by regulatory oversight.
• Asia-Pacific: Fastest growth owing to increasing awareness, healthcare expenditure, and demographic shifts towards older populations.
• Emerging Markets: Rising acceptance owing to generic availability and affordability, though regulatory hurdles persist.

3. Challenges & Risks

• Safety concerns regarding high-grade prostate tumors.
• Regulatory restrictions on off-label use.
• Competition from newer agents with improved safety profiles or targeted mechanisms.
• Patent litigation and generic price erosion.

4. Opportunities & Strategic Considerations

Manufacturers investing in:

• New combination formulations for BPH and alopecia.
• Longer-acting formulations.
• Biomarker-driven patient stratification to optimize efficacy.

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Conclusion & Future Outlook

Dutasteride’s evolving clinical profile positions it as a versatile drug. While its primary role in BPH remains dominant, ongoing trials and real-world evidence are expanding its potential applications in prostate cancer risk management and hair loss treatment. Market projections are optimistic but hinge on balancing efficacy, safety, regulatory approval, and competitive tactics.

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Key Takeaways

• Clinical research affirms Dutasteride’s superior DHT suppression and its potential in expanding indications such as androgenic alopecia.
• Safety considerations, particularly regarding prostate cancer risk, influence ongoing trials and regulatory evaluations.
• Patent expirations have facilitated generics entry, intensifying price competition but also expanding access.
• The global Dutasteride market is projected to grow steadily through 2030, driven by demographic shifts and new therapeutic opportunities.
• Strategic focus areas include combination therapies, novel formulations, and biomarker-guided patient selection.

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FAQs

Q1: What are the main approved uses of Dutasteride?
A1: Dutasteride is FDA- and EMA-approved for treating benign prostatic hyperplasia. It is also used off-label for male androgenic alopecia.

Q2: How does Dutasteride compare with Finasteride?
A2: Dutasteride inhibits both Type I and II 5-alpha-reductase enzymes, leading to more comprehensive DHT suppression than Finasteride, which primarily targets Type II, making it more effective in hair loss and BPH management.

Q3: Is Dutasteride safe for long-term use?
A3: Clinical trials indicate a generally favorable safety profile for long-term use, but concerns about potential risks, such as high-grade prostate tumors, necessitate ongoing pharmacovigilance.

Q4: What potential future indications are under clinical investigation for Dutasteride?
A4: Research explores its role in prostate cancer prevention, male pattern baldness, and possibly in conditions related to androgen excess, with trials ongoing.

Q5: How is the market for Dutasteride expected to evolve in emerging markets?
A5: Growing awareness, increasing aging populations, and the availability of generic options will likely accelerate market expansion, although regulatory landscape variations may influence uptake.

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References

1. McConnell JB, et al. (2003). "The REDUCE Trial." New England Journal of Medicine.
2. Pianka P, et al. (2017). "Efficacy of Dutasteride in Androgenic Alopecia." Journal of Dermatology.
3. Kim E, et al. (2021). "Safety profile of 5-alpha-reductase inhibitors." Urology.

(Note: All references are illustrative; actual citation details should be verified from current literature.)