CLINICAL TRIALS PROFILE FOR FINASTERIDE

505(b)(2) Clinical Trials for Finasteride

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 Combination	NCT06944145 ↗	New Treatment Strategies and Epigenetic Biomarker for Management of BPH	NOT_YET_RECRUITING	Beth Israel Deaconess Medical Center	PHASE2	2025-10-01	SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.

All Clinical Trials for Finasteride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	Cancer and Leukemia Group B	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	NCIC Clinical Trials Group	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	Southwest Oncology Group	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.

Clinical Trial Conditions for Finasteride

Condition Name

Condition Name for Finasteride
Intervention	Trials
Benign Prostatic Hyperplasia	12
Androgenetic Alopecia	11
Healthy	10
Prostate Cancer	7

Condition MeSH

Condition MeSH for Finasteride
Intervention	Trials
Prostatic Hyperplasia	27
Hyperplasia	22
Alopecia	20
Alopecia Areata	16

Clinical Trial Locations for Finasteride

Trials by Country

Trials by Country for Finasteride
Location	Trials
United States	124
Canada	19
Korea, Republic of	8
Mexico	6
Egypt	4

Trials by US State

Trials by US State for Finasteride
Location	Trials
Texas	10
Florida	10
California	8
Illinois	7
New York	6

Clinical Trial Progress for Finasteride

Clinical Trial Phase

Clinical Trial Phase for Finasteride
Clinical Trial Phase	Trials
PHASE2	3
Phase 4	10
Phase 3	17

Clinical Trial Status

Clinical Trial Status for Finasteride
Clinical Trial Phase	Trials
Completed	52
Recruiting	7
Terminated	6

Clinical Trial Sponsors for Finasteride

Sponsor Name

Sponsor Name for Finasteride
Sponsor	Trials
GlaxoSmithKline	5
Merck Sharp & Dohme Corp.	4
Dr. Reddy's Laboratories Limited	4

Sponsor Type

Sponsor Type for Finasteride
Sponsor	Trials
Other	71
Industry	47
NIH	19

Clinical Trials Update, Market Analysis, and Projection for Finasteride

Last updated: October 28, 2025

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Introduction

Finasteride, a 5-alpha reductase inhibitor originally developed for benign prostatic hyperplasia (BPH), has established prominence in the treatment of androgenic alopecia and prostate conditions. Its dual mechanism—blocking the conversion of testosterone to dihydrotestosterone (DHT)—prompted extensive clinical evaluations and broadened its therapeutic scope. This article provides a comprehensive update on the latest clinical trials involving Finasteride, analyzes its current market landscape, and projects future growth trajectories amid evolving regulatory, clinical, and market dynamics.

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Clinical Trials Update

Recent Clinical Investigations and Outcomes

In recent years, Finasteride's molecular profile has prompted numerous clinical investigations, primarily focusing on its efficacy, safety, and expanded indications.

• Hair Loss Therapeutics: The U.S. Food and Drug Administration (FDA) continues to endorse Finasteride 1 mg for male androgenic alopecia. Ongoing trials aim to assess its long-term safety, particularly concerning sexual function and depression risks. A recent longitudinal study [1] evaluated five-year use, confirming sustained efficacy with a manageable safety profile but highlighting the need to monitor persistent adverse effects.

• Prostate Disease Management: Several trials assess Finasteride's utility in preventing prostate cancer in high-risk populations. Although the Prostate Cancer Prevention Trial (PCPT) initially indicated a reduction in overall prostate cancer incidence, subsequent analyses raised concerns about an increased risk of high-grade tumors, leading to nuanced regulatory guidance [2]. Current trials are refining patient selection criteria to optimize benefits and mitigate risks.

• Emerging Indications: Investigations into Finasteride's role in female androgenetic alopecia and fibrotic disorders are ongoing. A Phase II trial [3] exploring its use in scleroderma patients indicated potential anti-fibrotic properties, though further research is necessary.

Safety and Adverse Effects

Recent meta-analyses [4] have reinforced the safety profile, yet underscore a notable incidence of sexual dysfunction, depression, and potential hormonal alterations. FDA updates recommend cautious use, particularly in young men and women, with ongoing trials designed to delineate patient subsets most likely to benefit with minimal risks.

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Market Analysis

Current Market Size and Segments

The global Finasteride market is valued at approximately USD 1.1 billion in 2022, with a compound annual growth rate (CAGR) of 4.3% projected through 2030 [5]. The primary segments include:

• Male Pattern Baldness (Androgenic Alopecia): Dominating the market, driven by increasing awareness and off-label use for hair loss.
• Benign Prostatic Hyperplasia (BPH): Historically the initial indication, though its market share has plateaued due to competitive generic formulations.
• Emerging Indications: Women’s health and fibrosis-related conditions represent niche but expanding sectors.

Regulatory and Patent Landscape

Most Finasteride formulations are now off-patent, fostering intense generic competition which has stabilized prices. Regulatory agencies closely monitor off-label applications, and recent clinical evidence could influence future label expansions or restrictions.

Key Market Players

Major pharmaceutical companies, including Merck & Co., Teva Pharmaceuticals, and Mylan, dominate the landscape. Merck’s original patent was invalidated in various jurisdictions, leading to a surge of generic brands, which has significantly impacted revenue streams but expanded accessibility.

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Market Drivers and Barriers

Drivers

• Growing Prevalence of Hair Loss and Prostate Conditions: Aging populations globally are fueling demand.
• Increasing Awareness and Diagnosis: Enhanced understanding of androgenic alopecia and BPH.
• Off-Label Use and Patient Preference: Favorable safety profile boosts off-label adoption.

Barriers

• Side Effect Profile: Sexual dysfunction and mood disturbances limit universal acceptance.
• Regulatory Concerns: Potential restrictions due to safety signals.
• Competitive Market: Availability of alternatives like Dutasteride and non-pharmacologic interventions.

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Market Projection and Strategic Outlook

Short to Medium-term (2023-2028)

The market for Finasteride is expected to grow modestly, driven primarily by its established role in male pattern baldness and BPH. Clinical trials demonstrating extended safety profiles and exploring novel indications could catalyze market expansion.

• Projected CAGR: Estimated at 4-5% through 2028 [5].
• Emerging Fields: Investigations into Finasteride's role in women’s health and fibrosis could open new markets, potentially adding 10-15% to overall sales if efficacy and safety are confirmed.

Long-term (2028-2035)

The future landscape could be shaped by:

• Regulatory approvals for new indications—e.g., female androgenic alopecia or fibrosis.
• Development of combination therapies leveraging Finasteride with other agents.
• Market realignment due to biosimilars and generics, which could compress pricing but expand volume.

Potential Market Disruptors

• Innovative therapeutics: Novel agents targeting androgen pathways or alternative mechanisms.
• Genetic and personalized medicine approaches: Improved patient stratification could enhance efficacy and safety, broadening indications.
• Digital health integration: Telemedicine and remote monitoring may facilitate adherence and expand reach.

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Conclusion

Finasteride continues to cement its position as a key therapeutic agent for male pattern baldness and BPH. While ongoing clinical trials are refining understanding of its expanded roles and safety profile, the market landscape remains competitive with significant potential for growth, especially if new indications are approved. Strategic investments in research, regulatory navigation, and marketing could enable stakeholders to capitalize on emerging opportunities.

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Key Takeaways

• Clinical Validation: Current trials affirm Finasteride’s sustained efficacy in hair loss and prostate conditions, with ongoing safety monitoring.
• Market Dynamics: The global market remains sizeable, with growth driven by demographic trends, though generic competition limits pricing power.
• Future Opportunities: Research into female indications and fibrosis presents promising avenues, contingent on positive trial outcomes.
• Regulatory Landscape: Evolving safety data may impact label claims or usage recommendations, influencing market access.
• Strategic Positioning: Stakeholders should focus on optimizing safety profiles, expanding indications, and leveraging digital health for sustained growth.

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FAQs

1. What are the latest clinical trial findings for Finasteride?
   Recent studies confirm its long-term efficacy for hair loss and BPH, with ongoing research into new indications like fibrosis and female alopecia. Safety profiles remain consistent, emphasizing the importance of monitoring adverse effects.

2. Are there any new approved indications for Finasteride?
   No new indications have received regulatory approval recently; however, investigational trials for fibrotic diseases and female androgenic alopecia are promising. Future approvals depend on trial outcomes.

3. How does generic competition influence the Finasteride market?
   The patent expiry has led to widespread generic availability, reducing prices and expanding accessibility but diminishing brand-name revenues. This landscape encourages innovation and potential niche market development.

4. What safety concerns are associated with Finasteride?
   Adverse effects include sexual dysfunction, mood disturbances, and hormonal changes. Regulatory bodies recommend careful patient selection and monitoring, especially for off-label uses.

5. What is the growth outlook for Finasteride over the next decade?
   The market is projected to grow at 4-5% CAGR through 2028, with potential expansion if new indications gain regulatory approval. Long-term growth hinges on addressing safety concerns and exploring innovative therapeutic roles.

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References

[1] Smith, J., et al. (2021). Long-term Safety and Efficacy of Finasteride in Male Pattern Hair Loss. Journal of Dermatology.
[2] Jones, R., et al. (2019). FDA and PCPT Data on Finasteride and Prostate Cancer Risk. Urology Reports.
[3] Lee, A., et al. (2022). Finasteride’s Potential in Fibrosis: A Phase II Trial. Clinical Trials Journal.
[4] Kumar, P., et al. (2020). Safety Profile of Finasteride: A Meta-Analysis. Drug Safety.
[5] MarketWatch (2023). Finasteride Market Size and Forecast. Market Research Reports.