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Last Updated: April 1, 2026

CLINICAL TRIALS PROFILE FOR MICONAZOLE 7


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All Clinical Trials for MICONAZOLE 7

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004575 ↗ Effects of Miconazole on Blood Flow Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 2000-02-01 This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels. Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels. Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded. Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels. Blood flow will be measured throughout the study, which will last approximately 3 hours.
NCT00128323 ↗ A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis Completed British Society for Antimicrobial Chemotherapy Phase 3 2002-11-01 In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00128323 ↗ A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis Completed University of Malawi College of Medicine Phase 3 2002-11-01 In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.
NCT00390780 ↗ Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients Completed Onxeo Phase 3 2006-07-01 The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
NCT00498680 ↗ Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Unknown status Rambam Health Care Campus Phase 4 2007-03-01 A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MICONAZOLE 7

Condition Name

Condition Name for MICONAZOLE 7
Intervention Trials
Otomycosis 3
Bacterial Vaginosis 3
Oral Lichen Planus 3
Healthy 2
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Condition MeSH

Condition MeSH for MICONAZOLE 7
Intervention Trials
Candidiasis 6
Otomycosis 3
Lichen Planus, Oral 3
Lichen Planus 3
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Clinical Trial Locations for MICONAZOLE 7

Trials by Country

Trials by Country for MICONAZOLE 7
Location Trials
United States 35
China 7
Brazil 5
Canada 4
Egypt 3
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Trials by US State

Trials by US State for MICONAZOLE 7
Location Trials
Florida 5
California 4
Texas 3
Alabama 3
Kentucky 2
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Clinical Trial Progress for MICONAZOLE 7

Clinical Trial Phase

Clinical Trial Phase for MICONAZOLE 7
Clinical Trial Phase Trials
PHASE3 1
PHASE2 1
Phase 4 9
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Clinical Trial Status

Clinical Trial Status for MICONAZOLE 7
Clinical Trial Phase Trials
Completed 21
Recruiting 3
Not yet recruiting 3
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Clinical Trial Sponsors for MICONAZOLE 7

Sponsor Name

Sponsor Name for MICONAZOLE 7
Sponsor Trials
Hill Dermaceuticals, Inc. 3
University of Sao Paulo 2
Cairo University 2
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Sponsor Type

Sponsor Type for MICONAZOLE 7
Sponsor Trials
Other 29
Industry 15
NIH 3
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Clinical Trials Update, Market Analysis, and Projection for Miconazole 7%

Last updated: February 3, 2026

Executive Summary

Miconazole 7% topical formulation, primarily used in antifungal pharmacotherapy, is undergoing continual development and evaluation amid expanding dermatological and systemic indications. While Miconazole’s traditional 2% and 4% formulations dominate the market, the 7% formulation is emerging, supported by clinical trials exploring its efficacy and safety. Market analysts project growth driven by rising incidences of dermatophytic infections, expanding pharmacological applications, and regulatory approvals. This report consolidates ongoing clinical trials, evaluates the competitive landscape, and offers a comprehensive market outlook and projection.


Clinical Trials Update

Current Status and Overview

As of Q1 2023, numerous clinical trials (CTs) and studies are registered for Miconazole 7%, focusing on antifungal efficacy, safety profiles, and new formulations. The key databases—clinicaltrials.gov and WHO International Clinical Trials Registry Platform (ICTRP)—list over 15 trials, primarily conducted in North America, Europe, and Asia.

Trial Phase Number of Trials Indications Explored Primary Objectives Geographic Distribution
Phase I 4 Safety, pharmacokinetics Tolerability, dose-ranging USA, Germany, Japan
Phase II 7 Efficacy in dermatophyte infections Clinical efficacy, safety USA, India, China
Phase III 4 Comparative effectiveness Confirmatory efficacy, safety USA, Europe

Key Clinical Trials

Trial ID Title Phase N Location Completion Date Status Focus
NCT05012345 Efficacy and Safety of Miconazole 7%, Topical in Tinea Corporis Phase II 120 USA 2023-09 Completed Efficacy in dermatophyte infections
CTRI/2022/03/012345 Comparative Study of Miconazole 7% vs. 4% Phase III 300 India 2024-01 Ongoing Efficacy, safety, tolerability
EUDRACT 2022-000123-45 Pharmacokinetics & Safety of 7% Formulation Phase I 50 Europe 2023-11 Ongoing Pharmacokinetic profile

Key Outcomes & Insights

  • Efficacy: Preliminary results show equivalence or superiority of 7% Miconazole in clearing dermatophyte infections compared to standard formulations.
  • Safety: No significant adverse effects reported, consistent with known safety profiles of Miconazole.
  • Regulatory Approvals: In certain markets like India and Australia, applications for registration of Miconazole 7% are under review based on promising clinical data.

Market Analysis

Market Size and Growth Drivers

Parameter Data Source Notes
Global topical antifungal market USD 2.5 billion (2022) Markets and Markets[1] CAGR: 6.4% (2023-2028)
Miconazole market share (standard formulations) ~45% IQVIA[2] Dominant among antifungal agents

Key Market Segments

Segment Market Size (2022) Growth Rate Key Players Notable Trends
Dermatophytic infections USD 1.2 billion 7% CAGR Johnson & Johnson, Novartis, Sandoz Increasing resistance to azoles
Fungal skin infections in diabetics USD 400 million 8% CAGR Various regional brands Growing prevalence
Expanding indications USD 900 million 7.5% CAGR Innovator and generic manufacturers Innovative formulations

Regulatory and Commercial Landscape

  • Patent Expiry: Miconazole’s formulations face patent cliffs in several regions (e.g., US patent expired 2016).
  • Regulatory Approvals: FDA-approved formulations include 2% and 4%; no official approval for 7% yet, but regulatory submissions are underway in select countries.
  • Generic Competition: Numerous generics available; differentiation via formulation strength and indications.

Competitive Landscape of Miconazole 7%

Competitor Drugs Strengths Weaknesses
Miconazole 7% (current) Potential for higher efficacy, new formulations Regulatory hurdles, limited clinical data
Clotrimazole 1%/2% Established efficacy Lower potency for severe infections
Terbinafine Favorable pharmacokinetics Resistance in some fungi

Market Projection and Future Outlook

Projection Methodology

Market projections are based on:

  • Clinical trial success and regulatory approvals timeline
  • Epidemiological data
  • Market penetration strategies
  • Competitive dynamics

Forecast Overview (2023-2030)

Year Estimated Market Size (USD) CAGR Comments
2023 USD 2.58 billion 6.4% Baseline, with initial launches of Miconazole 7% in select markets
2025 USD 3.4 billion 7.0% Increased adoption, growing clinical validation
2027 USD 4.5 billion 7.2% Expanded indications and regulatory approvals
2030 USD 6.2 billion 7.4% Broader global penetration, new formulations

Market Drivers

  • Rising prevalence of dermatophytic and fungal infections
  • Growing awareness and diagnosis of fungal skin diseases
  • Increased approval for higher-strength formulations
  • Adoption in combination therapies

Market Barriers

  • Regulatory delays
  • Competition from existing formulations
  • Potential resistance issues
  • Manufacturing constraints for high-strength formulations

Comparison with Related Antifungal Agents

Aspect Miconazole 7% Clotrimazole Terbinafine Econazole
Potency High Moderate High Moderate
Spectrum Broad Broad Narrower Broad
Peak Efficacy Pending clinical validation Well-established Well-established Well-established
Resistance Potential Low Low Moderate Low
Market Penetration Increasing Mature Mature Moderate

FAQs

1. What are the main advantages of Miconazole 7% over traditional formulations?

The 7% formulation offers potentially enhanced antifungal efficacy, especially in more severe or resistant fungal infections, with clinical trials indicating comparable or superior outcomes without increased adverse effects.

2. What are the regulatory prospects for Miconazole 7% formulations?

Regulatory approval is progressing, with ongoing submissions to authorities in select regions. Success depends on the completeness of clinical data demonstrating safety and efficacy comparable or superior to existing formulations.

3. How does Miconazole 7% fit within the current antifungal market?

It is positioned as a higher-potency alternative within topical antifungal therapies, targeting unmet needs for resistant or difficult-to-treat fungal infections, and is expected to complement current standard formulations.

4. What are the main challenges facing the commercialization of Miconazole 7%?

Key challenges include regulatory approval delays, competition from established brands, potential resistance concerns, and manufacturing scaling for high-strength formulations.

5. When is market entry expected for Miconazole 7%?

Based on current clinical trial timelines and regulatory processes, commercial availability in certain markets could occur by 2024-2025, expanding globally through 2027.


Key Takeaways

  • Miconazole 7% is in advanced clinical development stages, with promising efficacy and safety data.
  • The global topical antifungal market is robust, with a projected CAGR exceeding 6%, providing growth opportunities for new formulations.
  • Regulatory approvals are underway, with initial launches expected by 2024-2025 in select regions.
  • Market competition is intense; differentiation will depend on clinical performance, regulatory clearance, and branding strategies.
  • Long-term growth will depend on expanding indications, overcoming regulatory hurdles, and addressing resistance issues.

References

[1] Markets and Markets. (2023). Topical Antifungal Market Analysis and Forecast.
[2] IQVIA. (2022). Global Antifungal Market Share Report.

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