CLINICAL TRIALS PROFILE FOR PROPECIA

All Clinical Trials for PROPECIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00381108 ↗	Study of the Effects of Pomegranate Tablets on Enlarged Prostates	Unknown status	Jarrow Pharmaceuticals	Phase 1	2005-09-01	To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.
NCT00381108 ↗	Study of the Effects of Pomegranate Tablets on Enlarged Prostates	Unknown status	Pomegranate Health	Phase 1	2005-09-01	To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.
NCT00381108 ↗	Study of the Effects of Pomegranate Tablets on Enlarged Prostates	Unknown status	University of California, Irvine	Phase 1	2005-09-01	To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.
NCT00837252 ↗	Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy	Completed	National Eye Institute (NEI)	Phase 1/Phase 2	2009-02-01	Central serous chorioretinopathy (CSC) is a retinal disorder characterized by an accumulation of serous fluid under the retina. Although acute CSC tends to spontaneously resolve on its own with minimal sequelae, chronic CSC tends to persist and lead to irreversible visual loss. The pathogenesis of CSC is complex; however, systemic androgens have been implicated. Finasteride is an anti-androgen medication that is widely used in the treatment of various conditions. The objective of this study was to investigate the safety and potential efficacy of oral finasteride as a treatment for chronic CSC. Five participants with chronic CSC were enrolled into this uncontrolled, unmasked, Phase I/II study. An oral dose of finasteride, 5 mg daily, was administered to all participants for three months. Following this, finasteride was withheld and participants were observed for another three months. If a participant experienced a beneficial effect during the period in which he received finasteride and then experienced a relapse during the observation period, finasteride was re-instituted for the remaining period of the study. Relapse was defined as a return to the baseline maximum lesion height and/or return to baseline lesion volume.
NCT00842751 ↗	Oral T7 Oral Testosterone in Man	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2009-07-01	The purpose of this study is to test 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.
NCT00842751 ↗	Oral T7 Oral Testosterone in Man	Completed	National Institutes of Health (NIH)	Phase 2	2009-07-01	The purpose of this study is to test 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.

Clinical Trial Conditions for PROPECIA

Condition Name

Condition Name for PROPECIA
Intervention	Trials
Healthy	2
Prostate Cancer	2
Alopecia, Androgenetic	1
Androgenetic Alopecia	1

Condition MeSH

Condition MeSH for PROPECIA
Intervention	Trials
Alopecia	3
Alopecia Areata	2
Prostatic Neoplasms	2
Central Serous Chorioretinopathy	1

Clinical Trial Locations for PROPECIA

Trials by Country

Trials by Country for PROPECIA
Location	Trials
United States	6
Canada	2
Hungary	1
Israel	1
Germany	1

Trials by US State

Trials by US State for PROPECIA
Location	Trials
Illinois	1
Missouri	1
Kansas	1
Washington	1
Maryland	1

Clinical Trial Progress for PROPECIA

Clinical Trial Phase

Clinical Trial Phase for PROPECIA
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for PROPECIA
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	1
Unknown status	1

Clinical Trial Sponsors for PROPECIA

Sponsor Name

Sponsor Name for PROPECIA
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
University of Kansas	1
University of Chicago	1

Sponsor Type

Sponsor Type for PROPECIA
Sponsor	Trials
Industry	6
Other	5
NIH	3

PROPECIA Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What Is the Clinical Trial Status of PROPECIA?

PROPECIA (finasteride 1 mg) has undergone multiple clinical trials primarily focused on its efficacy for androgenetic alopecia (male pattern baldness). Its initial approval by the FDA occurred in 1997 for hair loss. No recent large-scale phase III trials are publicly reported, indicating the drug's regulatory approval status remains stable with ongoing monitoring for post-market safety.

Key trial data:

• Initial Trials: Conducted in the early 1990s involving approximately 1,500 patients across multiple centers.
• Post-Approval Studies: Focused mainly on long-term safety, involving over 10,000 patients. These studies support its prescription label but do not typically include new efficacy data.
• Recent Trials: No new pivotal phase III studies are publicly registered or ongoing as per ClinicalTrials.gov.

The lack of new significant clinical trials suggests PROPECIA remains an established treatment with a well-characterized safety profile, diminishing the likelihood of regulatory changes unless new safety concerns emerge.

What Is the Market Landscape for PROPECIA?

Market Size and Segments

The global hair loss market was valued at approximately USD 4.8 billion in 2020, with prescription drugs accounting for about USD 1.7 billion. PROPECIA's share within this segment is estimated at 40-50%, primarily in North America and Europe.

Main market segments:

• Male androgenetic alopecia: Dominates the prescription market. PROPECIA is typically prescribed for men aged 18-41.
• Off-label use: Some physicians prescribe for women, although FDA approval does not extend to female use, and this constitutes a small segment due to limited evidence.

Key Competitors

Drug/Product	Active Ingredient	Market Share	Approval Status
PROPECIA	Finasteride 1 mg	40-50%	FDA-approved
Rogaine (minoxidil)	Minoxidil	30-35%	FDA-approved (OTC in some regions)
Dutasteride (Avodart)	Dutasteride	10-15%	Off-label use in hair loss
Other treatments	Various	Remaining market share	Limited approval or off-label use

Market Dynamics

• Pricing: PROPECIA retails for USD 50-70 per month in the U.S. for brand-name versions; generics are priced lower.
• Prescribing Trends: Steady demand driven by dermatologists and primary care physicians. Minimal variation due to stable safety profile.
• Regulatory Landscape: Limited recent regulation changes; ongoing monitoring for reports of adverse effects like sexual dysfunction.

What Are the Future Market Projections?

Growth Drivers

• Increasing awareness: More men seek medical treatment for hair loss.
• Aging populations: Older males experience more androgenetic alopecia.
• Product innovation: Combining finasteride with topical agents or alternative formulations.

Challenges

• Safety concerns: Reports of sexual side effects lead some to discontinue use.
• Competition from new therapeutics: Developments in JAK inhibitors, platelet-rich plasma (PRP), or stem-cell therapies could shift market share.
• Regulatory restrictions: Potential future bans or restrictions if new safety data emerge.

Forecasts (2023-2030)

Year	Estimated Market Size (USD)	CAGR	Notes
2023	2.1 billion	2.5%	Solid demand with slow growth due to competition and safety concerns
2025	2.3 billion	3.0%	Market expansion driven by aging male demographics
2030	2.8 billion	3.5%	Market stabilizes with increased availability of combination therapies

Strategic Opportunities

• Expansion into emerging markets: Low current penetration, especially in Asia-Pacific.
• Formulation improvements: Developing topical or lower-dose regimens.
• Regulatory submissions for female indications: Could unlock additional growth if approved.

Key Takeaways

• PROPECIA has maintained a stable regulatory and clinical profile since FDA approval in 1997.
• The drug holds a significant portion of the hair loss treatment market, with steady demand primarily in North America and Europe.
• Future growth will hinge on safety perception, competitive advances, and expansion into new markets or indications.
• Current clinical trials are limited to post-market safety surveillance, with no new efficacy trials announced.
• The overall market growth remains moderate, around 2.5-3.5% CAGR through 2030, influenced by demographic trends and treatment innovations.

Frequently Asked Questions

1. Are there ongoing clinical trials for PROPECIA?
No significant or pivotal trials are registered or underway, signifying stability in its current approval status.

2. Can PROPECIA be used in women?
FDA approval is limited to male patients. Off-label use exists, but safety concerns diminish broader prescribing.

3. What are the main safety issues associated with PROPECIA?
Sexual dysfunction, decreased libido, and depression reports are noted, influencing some discontinuations.

4. How does PROPECIA compare with topical alternatives?
It offers systemic benefits with consistent efficacy; topical agents like minoxidil provide alternative options often used in combination therapy.

5. What regulatory risks could affect PROPECIA’s market?
Potential bans or restrictions could occur if new safety data indicates significant adverse risk, though none are currently reported.

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References

[1] ClinicalTrials.gov. (2023). Finasteride clinical trials. U.S. National Library of Medicine.
[2] MarketWatch. (2023). Hair loss treatment market size and forecasts.
[3] U.S. Food and Drug Administration. (1997). FDA approval documentation for PROPECIA.
[4] Statista. (2023). Hair loss treatment market overview.
[5] IBISWorld. (2022). Hair loss treatment industry report.