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Last Updated: January 4, 2025

CLINICAL TRIALS PROFILE FOR MINOXIDIL


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for minoxidil

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00876200 ↗ Efficacy of Minoxidil in Children With Williams-Beuren Syndrome Completed Hospices Civils de Lyon Phase 2 2009-03-01 The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin locus. Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children. These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications. Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis. Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children. Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome. Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension. Total study duration:30 months including a 12 month-recruitment period
NCT00607477 ↗ Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension Terminated University of Chicago N/A 2008-01-01 The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.
NCT00418730 ↗ Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss Completed Neosil, Inc. Phase 2 2007-01-01 The purpose of this study is to measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.
NCT00175617 ↗ Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss Completed University of British Columbia Phase 2 2005-09-01 This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for minoxidil

Condition Name

218760-20246810121416182022Androgenetic AlopeciaAlopecia AreataAlopeciaFemale Pattern Hair Loss[disabled in preview]
Condition Name for minoxidil
Intervention Trials
Androgenetic Alopecia 21
Alopecia Areata 8
Alopecia 7
Female Pattern Hair Loss 6
[disabled in preview] 0
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Condition MeSH

4948005101520253035404550AlopeciaAlopecia AreataHypertensionHypotrichosis[disabled in preview]
Condition MeSH for minoxidil
Intervention Trials
Alopecia 49
Alopecia Areata 48
Hypertension 2
Hypotrichosis 2
[disabled in preview] 0
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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
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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
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Clinical Trial Progress for minoxidil

Clinical Trial Phase

25.5%20.0%52.7%0051015202530Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for minoxidil
Clinical Trial Phase Trials
Phase 4 14
Phase 3 11
Phase 2/Phase 3 1
[disabled in preview] 29
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Clinical Trial Status

54.1%16.4%13.1%16.4%0101520253035CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for minoxidil
Clinical Trial Phase Trials
Completed 33
Recruiting 10
Not yet recruiting 8
[disabled in preview] 10
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Clinical Trial Sponsors for minoxidil

Sponsor Name

trials012345678Mae Fah Luang University HospitalAssiut UniversityGalderma Laboratories, L.P.[disabled in preview]
Sponsor Name for minoxidil
Sponsor Trials
Mae Fah Luang University Hospital 5
Assiut University 4
Galderma Laboratories, L.P. 2
[disabled in preview] 8
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Sponsor Type

69.5%28.0%00102030405060OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for minoxidil
Sponsor Trials
Other 57
Industry 23
U.S. Fed 2
[disabled in preview] 0
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Minoxidil Market Analysis and Financial Projection

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."

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