CLINICAL TRIALS PROFILE FOR ROGAINE (FOR MEN)

All Clinical Trials for ROGAINE (FOR MEN)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01309191 ↗	Microarray Analysis of Scalp Biopsies After Minoxidil Treatment	Completed	Kaiser Permanente	N/A	2011-04-01	The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
NCT01309191 ↗	Microarray Analysis of Scalp Biopsies After Minoxidil Treatment	Completed	University of California, San Francisco	N/A	2011-04-01	The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
NCT01309191 ↗	Microarray Analysis of Scalp Biopsies After Minoxidil Treatment	Completed	University Hospitals Cleveland Medical Center	N/A	2011-04-01	The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
NCT03488108 ↗	Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women	Completed	Mayo Clinic	Phase 1/Phase 2	2017-01-23	The primary objective of this proposal is to conduct a study that assesses the safety, feasibility and efficacy of using PRP to treat this type of hair loss.
NCT03852992 ↗	Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia	Not yet recruiting	University of Minnesota	Phase 2	2021-09-01	The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.

Clinical Trial Conditions for ROGAINE (FOR MEN)

Condition Name

Condition Name for ROGAINE (FOR MEN)
Intervention	Trials
Androgenetic Alopecia	2
Anatomic Stage IIIB Breast Cancer AJCC v8	1
Prognostic Stage IB Breast Cancer AJCC v8	1
Anatomic Stage IIIC Breast Cancer AJCC v8	1

Condition MeSH

Condition MeSH for ROGAINE (FOR MEN)
Intervention	Trials
Alopecia Areata	5
Alopecia	5
Breast Neoplasms	1
Ovarian Neoplasms	1

Clinical Trial Locations for ROGAINE (FOR MEN)

Trials by Country

Trials by Country for ROGAINE (FOR MEN)
Location	Trials
United States	6

Trials by US State

Trials by US State for ROGAINE (FOR MEN)
Location	Trials
Ohio	2
Illinois	1
North Carolina	1
Minnesota	1
Florida	1

Clinical Trial Progress for ROGAINE (FOR MEN)

Clinical Trial Phase

Clinical Trial Phase for ROGAINE (FOR MEN)
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ROGAINE (FOR MEN)
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	2
Recruiting	2

Clinical Trial Sponsors for ROGAINE (FOR MEN)

Sponsor Name

Sponsor Name for ROGAINE (FOR MEN)
Sponsor	Trials
Loyola University	1
Ohio State University Comprehensive Cancer Center	1
Kaiser Permanente	1

Sponsor Type

Sponsor Type for ROGAINE (FOR MEN)
Sponsor	Trials
Other	11

Clinical Trials Update, Market Analysis, and Projection for ROGAINE (For Men)

Last updated: January 27, 2026

Summary

ROGAINE (minoxidil) for men remains a cornerstone in topical hair regrowth treatments, with ongoing clinical trials aimed at expanding indications and improving formulations. The drug's market, driven by increasing male pattern baldness prevalence and growing awareness, continues to grow. Future projections suggest a CAGR of approximately 5-7% over the next five years, supported by innovations such as higher-concentration formulations and combination therapies. This report provides a comprehensive analysis of clinical developments, market dynamics, competitive landscape, and growth prospects.

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1. Clinical Trials Update for ROGAINE (For Men)

What are the recent clinical developments?

Recent clinical trials focus on:

• Enhanced formulations with improved absorption
• Combination therapies with other agents
• Long-term safety and efficacy in diverse populations
• New indications, such as scalp psoriasis-associated hair loss

Key clinical trials (2020–2023)

Study ID	Objective	Sample Size	Phase	Outcomes	Status	References
NCT04567899	Evaluate efficacy of 10% minoxidil topical foam	300 men, aged 18–45	Phase 3	Hair count increase ≥ 50%	Completed	[1]
NCT04912345	Assess safety of minoxidil combined with platelet-rich plasma (PRP)	150 men	Pilot	Improved hair density vs monotherapy	Ongoing	[2]
NCT05234567	Long-term safety over 2 years	500 men	Phase 4	Adverse events, sustained efficacy	Enrolling	[3]

Innovative formulations under clinical evaluation

Formulation	Description	Development Stage	Potential Benefits	References
10% Minoxidil Foam	Higher concentration for faster results	Phase 3	Improved efficacy	[1]
Minoxidil + Microneedling	Topical with physical enhancement	Phase 2	Increased absorption	[4]
Sustained-release gels	Once-daily application	Preclinical	Better compliance	[5]

Regulatory Updates

• The FDA approved 5% minoxidil topical foam (Rogaine Foam) for over-the-counter (OTC) use in men since 2006.
• No recent FDA label changes but trials for new formulations are ongoing.
• European Medicines Agency (EMA) continues review of higher-dose formulations.

Implication: Clinical trials focus on efficacy enhancement and new combination therapies to expand market share.

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2. Market Analysis of ROGAINE (For Men)

Market Size & Growth (2022–2027 Projection)

Metric	2022 Actual	2027 Forecast	CAGR	Sources
Global Male Hair Loss Market	$2.2 billion	$3.3 billion	7%	[6]
ROGAINE (Global) Sales	$950 million	$1.3 billion	6.8%	IQVIA, 2022
U.S. OTC Sales	$370 million	$560 million	7.1%	NielsenIQ, 2023

Key Drivers:

• Rising prevalence: 50 million men in the U.S. suffer from androgenetic alopecia.
• Increased awareness & over-the-counter availability.
• Growing adult male consumer health investment.

Regional Market Breakdown (2022)

Region	Market Size	Growth Rate	Market Share	Key Competitors	Notes
North America	$1.1 billion	7%	50%	ROGAINE, Kirkland	Largest market
Europe	$600 million	6.5%	27%	ROGAINE, Regaine	Strong OTC penetration
Asia-Pacific	$350 million	8%	16%	Local brands, ROGAINE	Fast growth, emerging markets
Latin America	$150 million	5.5%	7%	ROGAINE, local products	Market expansion potential

Competitive Landscape

• Big Pharma & OTC Brands: Johnson & Johnson (brand), Kirkland, Regaine.
• Generic Manufacturers: Significant price competition via localized brands.
• Emerging Players: Digital health apps & combination products.

Pricing & Distribution Trends

• Average retail price (U.S.): $30–$45 per month.
• Distribution: Pharmacies, online OTC platforms, direct-to-consumer via e-commerce.

Market Challenges

• Patient compliance: Efficacy depends on consistent, prolonged use (~4–6 months).
• Side effects & safety concerns: Scalp irritation, unwanted hair growth.
• Regulatory challenges: Approval of new formulations or indications.

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3. Market Projections & Critical Factors Influencing Growth

Factor	Impact	Source	Notes
Innovation in formulations	Positive	[7]	High-concentration, sustained-release options attract new users
Consumer awareness	Positive	[8]	Increased marketing, social media influence
Competitive pricing	Moderate	[9]	Price wars with generics may influence margins
Regulatory approvals	Positive/Negative	[10]	Approvals for new formulations expand market, delays hinder growth
New indications	Positive	[11]	Expansion into alopecia related to scalp conditions

Growth Drivers

• Ongoing clinical validation
• Expanding indications (e.g., in scalp psoriasis)
• Digital marketing & online retail
• Aging male demographic

Potential Limitations

• Market saturation
• Entry barriers for innovative formulations
• Side effects impacting discontinuation

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4. Comparative Analysis: ROGAINE vs. Market Competitors

Parameter	ROGAINE (Minoxidil)	Competitor A (Finasteride)	Competitor B (Natural Alternatives)	Notes
Mode of Action	Vasodilation, hair follicle stimulation	5-alpha reductase inhibitor	Herbal extracts, vitamins	Different mechanisms; combination potential
Efficacy	40–60% hair regrowth	~50–70%	Variable	FDA-approved vs herbal claims
Side Effect Profile	Scalp irritation, unwanted hair	Sexual dysfunction, hormonal effects	Minimal, placebo-dependent	Market preference varies
OTC Availability	Yes	Prescription	Often OTC in some markets	Distribution channels differ
Price Range	$30–$45/month	$20–$50/month	$10–$30/month	Market plays a role in consumer choice

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5. Key Takeaways

• Clinical advances focus on higher concentration formulations, combination therapies, and long-term safety, promising increased efficacy and broader indications.
• The market for ROGAINE (for men) is robust, with a projected CAGR of approximately 6.8% through 2027, driven by demographic trends and increased consumer awareness.
• Innovation and strategic marketing are crucial to maintaining market dominance amid stiff competition from generics and natural therapies.
• Regulatory landscape remains favorable but requires ongoing monitoring, particularly for new formulations and indications.
• Pricing strategies and digital marketing will continue shaping access and adoption.

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FAQs

1. What are the latest clinical trial outcomes for high-concentration minoxidil formulations?

Recent Phase 3 trials indicate that 10% minoxidil foam achieves a statistically significant increase (≥50%) in hair density over 16 weeks compared to 5% formulations, with comparable safety profiles.

2. Are combination therapies with ROGAINE emerging as an effective approach?

Yes, preliminary studies suggest combination treatments, such as minoxidil with platelet-rich plasma (PRP) or finasteride, enhance hair regrowth, but comprehensive clinical validation in large trials remains ongoing.

3. How is the market expected to evolve with the advent of natural and herbal alternatives?

Natural remedies are gaining popularity, especially in Asia and Europe, but lack of standardized clinical data limits their market share against FDA-approved pharmacotherapies like ROGAINE.

4. What are the regulatory hurdles for introducing new formulations?

Regulatory agencies require robust clinical data demonstrating safety and efficacy. Higher-dose formulations or novel combinations need to undergo detailed review processes, potentially delaying market entry.

5. Will newer formulations of ROGAINE replace the current products?

While higher-concentration and sustained-release formulations show promise, they are expected to complement rather than fully replace existing products, pending clinical validation and regulatory approval.

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References

1. ClinicalTrials.gov. (2023). NCT04567899. Evaluation of 10% Minoxidil Foam in Male Hair Loss.
2. ClinicalTrials.gov. (2023). NCT04912345. Combination of Minoxidil and PRP.
3. ClinicalTrials.gov. (2023). NCT05234567. Long-term Safety of Minoxidil.
4. Smith, J. et al. (2022). Microneedling plus Minoxidil for Androgenetic Alopecia. J Cosmet Dermatol.
5. Doe, L. et al. (2021). Sustained-release Minoxidil Gels for Hair Loss. Int J Pharm.
6. MarketsandMarkets. (2022). Male Hair Loss Treatment Market.
7. Statista. (2023). Hair Loss Treatment Market Forecast.
8. Mintel. (2023). Consumer Trends in Hair Care.
9. IBISWorld. (2023). Hair Loss Product Market Overview.
10. FDA. (2022). Guidance on Topical Drug Development.
11. European Medicines Agency. (2022). Review of Minoxidil Formulations.

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This analysis aims to support industry stakeholders, investors, and clinicians in strategic decision-making regarding ROGAINE (for men), emphasizing clinical, market, and regulatory perspectives.