CLINICAL TRIALS PROFILE FOR MINOXIDIL

505(b)(2) Clinical Trials for minoxidil

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
OTC	NCT01325337 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
OTC	NCT01325350 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.

All Clinical Trials for minoxidil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00151515 ↗	A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 3	2003-10-01	The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for minoxidil

Condition Name

Condition Name for minoxidil
Intervention	Trials
Androgenetic Alopecia	21
Alopecia Areata	8
Alopecia	7

Condition MeSH

Condition MeSH for minoxidil
Intervention	Trials
Alopecia	49
Alopecia Areata	48
Hypotrichosis	2

Clinical Trial Locations for minoxidil

Trials by Country

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Trials by Country for minoxidil
Location	Trials
United States	58
Egypt	9
Thailand	7
Germany	7
France	5

Trials by US State

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−

Trials by US State for minoxidil
Location	Trials
Texas	6
Minnesota	5
Ohio	5
Florida	4
California	4

Clinical Trial Progress for minoxidil

Clinical Trial Phase

Clinical Trial Phase for minoxidil
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for minoxidil
Clinical Trial Phase	Trials
Completed	33
Recruiting	10
Not yet recruiting	8

Clinical Trial Sponsors for minoxidil

Sponsor Name

Sponsor Name for minoxidil
Sponsor	Trials
Mae Fah Luang University Hospital	5
Assiut University	4
Johnson & Johnson Consumer and Personal Products Worldwide	2

Sponsor Type

Sponsor Type for minoxidil
Sponsor	Trials
Other	57
Industry	23
U.S. Fed	2

Minoxidil: Clinical Trials, Market Analysis, and Projections

Introduction to Minoxidil

Minoxidil, a potent vasodilator, has been widely used for the treatment of androgenetic alopecia (AGA) and other forms of hair loss. Its efficacy and safety have been extensively studied, and it remains a cornerstone in the management of hair loss.

Clinical Trials and Efficacy

Comparison of Different Concentrations

Clinical trials have compared the efficacy of different minoxidil concentrations. A randomized, self-comparative clinical trial involving 66 patients with AGA evaluated the safety and efficacy of 15% minoxidil solution versus the 5% solution. The study found that the 15% formulation had significantly better efficacy than the 5% solution at weeks 12 and 24, based on participant assessment of treatment satisfaction, Investigator's Global Assessment (IGA), global scalp photography, and phototrichography. There was no significant difference in adverse effects between the two groups[1].

Safety and Satisfaction

Another study involving 1495 men aged 20-40 years using the 5% minoxidil formulation in routine clinical practice showed that while discontinuation due to adverse effects was rare, many patients stopped treatment due to perceived fewer effects or aversion to topical treatment[1].

Market Analysis

Global Market Size and Growth

The global minoxidil market is projected to grow significantly over the next few years. As of 2020, the market was valued at $1.9 billion and is expected to reach $2.4 billion by 2025, with a compound annual growth rate (CAGR) of 4.3% during this period[2][5].

Drivers of Market Growth

The growth of the minoxidil market is driven by several factors, including the increasing prevalence of alopecia, particularly androgenetic alopecia, and the rising geriatric population. Hair loss resulting from chronic diseases also contributes to the market's expansion[2].

Market Segmentation

The minoxidil market is segmented based on type (2%, 5%, and 10%), form (topical and oral), and application (alopecia and chronic diseases). The topical form remains the most common, with the 5% concentration being the most widely used[5].

Future Potential and Developments

Emerging Treatments

While minoxidil remains a standard treatment for hair loss, new treatments are on the horizon. For instance, Absci's novel drug candidate, ABS-201, has shown superior hair regrowth compared to minoxidil in preclinical studies. This drug is expected to enter Phase 1 clinical trials in the first half of 2026 and targets a large market of 80 million U.S. patients with androgenic alopecia[4].

Research and Development

There is increasing research and development activity aimed at expanding the use of minoxidil beyond hair loss. For example, oral minoxidil has been explored for the treatment of late alopecia in cancer patients, highlighting its potential in other therapeutic areas[3].

Competitive Landscape

Key Players

The minoxidil market is dominated by several major pharmaceutical companies, including Dr. Reddy’s Laboratories, Cipla, Johnson & Johnson, Novartis AG, Pfizer Inc., and Teva Pharmaceutical Industries Ltd. These companies are involved in various market strategies such as mergers, acquisitions, joint ventures, and collaborations to maintain their market share[5].

Regulatory and Technological Advances

Ongoing Scientific Discoveries

The market is influenced by ongoing scientific discoveries and technological advances. For instance, the use of AI-driven drug development platforms, as seen with Absci's pipeline, is revolutionizing the way new treatments are developed and brought to market[4].

Market Challenges and Opportunities

Despite the growth potential, the minoxidil market faces challenges such as competition from emerging treatments and the need for continuous innovation. However, the increasing prevalence of alopecia and the expanding geriatric population present significant opportunities for market growth[2][5].

Projections and Forecast

Market Size and CAGR

By 2023, the global minoxidil market is estimated to be valued at $1,095.5 million and is expected to exhibit a CAGR of 4.8% during the forecast period up to 2030[3].

Regional Analysis

The market is segmented geographically, with different regions showing varying growth rates. Understanding these regional dynamics is crucial for companies looking to expand their market presence[5].

Key Takeaways

• Efficacy and Safety: Clinical trials have shown that higher concentrations of minoxidil, such as 15%, can be more effective than the standard 5% solution.
• Market Growth: The global minoxidil market is expected to grow from $1.9 billion in 2020 to $2.4 billion by 2025, driven by increasing cases of alopecia and a rising geriatric population.
• Emerging Treatments: New drug candidates like ABS-201 are showing promise and could potentially disrupt the market.
• Competitive Landscape: Major pharmaceutical companies dominate the market, with ongoing research and development activities driving innovation.
• Regulatory and Technological Advances: AI-driven drug development and other technological advances are shaping the future of the minoxidil market.

FAQs

What is the current market size of the global minoxidil market?

The global minoxidil market was valued at $1.9 billion in 2020 and is projected to reach $2.4 billion by 2025[2][5].

What are the main drivers of the minoxidil market growth?

The main drivers include the increasing prevalence of alopecia, the rising geriatric population, and hair loss resulting from chronic diseases[2].

Is there any difference in efficacy between 5% and 15% minoxidil solutions?

Yes, clinical trials have shown that the 15% minoxidil solution has significantly better efficacy than the 5% solution at weeks 12 and 24[1].

What are the emerging treatments for hair loss that could compete with minoxidil?

Absci's novel drug candidate, ABS-201, has shown superior hair regrowth compared to minoxidil in preclinical studies and is expected to enter Phase 1 clinical trials in 2026[4].

What is the projected CAGR for the global minoxidil market up to 2030?

The global minoxidil market is expected to exhibit a CAGR of 4.8% during the forecast period up to 2030[3].

Sources

1. Mapar and Omidian, 2007: "Comparison of different strengths of minoxidil in the treatment of androgenetic alopecia."
2. ResearchAndMarkets.com: "Global Minoxidil Market Report 2021: Product Pipeline Future, Potential Treatments, Strategies and Developments 2020-2025."
3. Coherent Market Insights: "Minoxidil Market Size, Trends and Forecast to 2030."
4. StockTitan: "Absci's Novel Hair Loss Drug Shows Promise, Outperforms Minoxidil."
5. ResearchAndMarkets.com: "Global Minoxidil Market 2020-2025."