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Onychomycosis Pipeline Analysis Report 2025
Market Report I 2025-05-12 I 100 Pages I EMR Inc.
Onychomycosis Drug Pipeline Analysis 2025
Onychomycosis, a fungal infection of the nails, affects between 1% and 8% of the general population and 19% to 51.9% of individuals receiving hemodialysis. Despite available therapies like oral and topical antifungals, many patients experience suboptimal results and lengthy treatment periods. This highlights a considerable unmet need for more effective solutions. Increasing attention is being directed toward novel antifungal agents, enhanced drug delivery methods, and therapies with better safety profiles. These developments are expected to drive progress in onychomycosis treatment, aiming to fill current therapeutic gaps and deliver improved health outcomes for affected individuals.
Key Takeaways
- The limited efficacy and prolonged duration of current therapies such as topical and oral antifungals have created a high unmet clinical need, prompting the development of novel treatment approaches.
- The pipeline is witnessing increased focus on innovative drug delivery systems and targeted antifungal therapies aimed at enhancing drug penetration, reducing side effects, and improving treatment adherence.
- Pharmaceutical companies are increasing research investments and forming strategic partnerships to accelerate clinical trials and bring more effective onychomycosis treatments to market.
Report Coverage
The Onychomycosis Drug Pipeline Analysis Report 2025 provides an in-depth overview of recent advancements and ongoing clinical trials aimed at improving onychomycosis treatment and prevention. The report explores the development of novel therapies for Narcolepsy, including next-generation biologics, immunomodulators, and targeted treatments aimed at improving immune response and managing disease progression. It also evaluates innovative treatment strategies, industry collaborations, and regulatory advancements, highlighting efforts to accelerate the development of safe and effective therapies for the management and potential eradication of narcolepsy.
Onychomycosis Drug Pipeline Outlook
Onychomycosis is a common fungal nail infection primarily caused by dermatophytes, yeasts, or non-dermatophyte moulds. It typically results in discoloured, thickened, and brittle nails, affecting both aesthetic appearance and nail health. Treatment is challenging due to the infection's persistence and resistance to conventional therapies. Current drug development focuses on advanced topical and oral antifungals with improved nail penetration, shorter treatment durations, and better safety profiles to enhance therapeutic outcomes.
Onychomycosis - Pipeline Drug Profiles
Recent developments in treating onychomycosis have introduced several promising drugs currently in clinical trials, reflecting significant advancements in the field.
Drug: MOB015B
MOB015B, developed by Moberg Pharma AB, is a topical terbinafine formulation designed to enhance nail penetration and antifungal efficacy for treating onychomycosis. It aims to offer a more convenient and shorter treatment duration compared to oral therapies. Clinical trials have shown promising cure rates and improved safety profiles, particularly for patients with mild to moderate infection.
Drug: ATB1651-102
ATB1651-102, developed by AmtixBio Co., Ltd., is a topical antifungal candidate targeting onychomycosis. It is formulated to improve drug delivery to the nail bed, enhancing efficacy and reducing systemic side effects. The drug is currently under investigation for its safety, tolerability, and therapeutic response, particularly in patients with resistant or recurrent fungal nail infections.
Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of onychomycosis based on various segmentations such as:
Analysis by Route of Administration
- Oral
Oral therapies remain a cornerstone in the treatment of onychomycosis due to their ability to reach deep-seated fungal infections. Drugs administered orally, such as terbinafine or itraconazole, have shown higher efficacy for severe or widespread nail infections. However, systemic exposure may lead to side effects, prompting ongoing development of safer oral antifungal candidates with improved tolerability and targeted action.
- Parenteral
Parenteral administration is less common in onychomycosis but is explored in severe or resistant cases where other routes fail. Injectable antifungals can ensure rapid systemic availability and may be considered for immunocompromised patients. Research into novel parenteral agents focuses on increasing bioavailability, reducing toxicity, and enhancing treatment compliance in complex clinical scenarios.
- Other
Alternative routes, particularly topical and transungual drug delivery, are increasingly preferred for mild to moderate onychomycosis. Topical formulations aim to penetrate the nail plate effectively while minimising systemic side effects. Advances include nail lacquers, sprays, and innovative carriers like nanoparticles or gels. These approaches improve patient adherence and represent a growing area of therapeutic innovation in onychomycosis management.
Analysis by Phase
The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total onychomycosis clinical trials.
Preclinical Phase: Laboratory and animal studies to assess safety and efficacy.
1. Phase I: Small-scale human trials focusing on safety and dosage.
2. Phase II: Larger trials to evaluate efficacy and side effects.
3. Phase III: Large-scale trials to confirm effectiveness, monitor side effects, and compare with standard treatments.
4. Phase IV: Post-marketing studies to gather more information on risks, benefits, and optimal use.
Analysis by Drug Class
Small Molecules
Small molecules form the backbone of onychomycosis treatment. These include antifungal agents such as allylamines and azoles that inhibit fungal cell wall synthesis. Pipeline candidates focus on enhancing nail penetration, reducing resistance, and minimising adverse effects. Their ease of formulation and cost-effectiveness make them a dominant class in ongoing drug development.
Monoclonal Antibodies
Monoclonal antibodies are not yet widely used for onychomycosis but represent an emerging therapeutic area. These biologics offer precise targeting of fungal antigens and immune modulation. Early-stage research is exploring their potential to treat resistant infections or complement existing antifungal regimens, particularly in patients with chronic or recurrent onychomycosis.
Peptides
Peptide-based antifungals are gaining attention for their potent antifungal activity and favourable safety profiles. Designed to disrupt fungal membranes or inhibit growth, they are being investigated for topical formulations. Peptides offer a novel mechanism of action, making them promising candidates in tackling resistant strains and enhancing treatment outcomes in onychomycosis.
Gene Therapies
Gene therapies are currently in the exploratory phase for onychomycosis. These approaches aim to modify host or fungal genes to enhance resistance or eradicate infection. While still experimental, gene therapy holds long-term promise, particularly for individuals with genetic predispositions to chronic fungal infections or those unresponsive to conventional treatments.
Onychomycosis Clinical Trials Assessment- Competitive Dynamics
Here are a few notable participants involved in onychomycosis research and development:
- Moberg Pharma AB
Moberg Pharma AB is a Swedish specialty pharma company focusing on topical treatments for nail and skin disorders. It is actively involved in developing innovative therapies for onychomycosis, with a lead candidate in late-stage clinical trials. The company emphasises rapid, visible improvement and high cure rates in its therapeutic approach.
- AmtixBio Co., Ltd.
AmtixBio Co., Ltd. is a South Korean biopharmaceutical firm engaged in dermatological and antifungal drug development. The company is exploring novel topical and oral antifungal treatments for onychomycosis, aiming to enhance efficacy, safety, and patient compliance. Its pipeline features promising candidates in early to mid-stage clinical trials.
- Hallux, Inc.
Hallux, Inc. is a US-based clinical-stage biotech company dedicated to developing antifungal therapeutics, particularly for nail infections such as onychomycosis. The company's core product, a topical formulation, is designed to improve nail penetration and fungal eradication. It targets both treatment effectiveness and improved cosmetic outcomes for patients.
- Bausch Health Companies Inc.
Bausch Health Companies Inc., headquartered in Canada, develops and markets pharmaceutical products across multiple therapeutic areas. In onychomycosis, it offers established antifungal therapies and is involved in enhancing delivery systems and formulations. Its presence in dermatology supports ongoing development in treating fungal infections of the nail.
- Pfizer Inc.
Pfizer Inc., a global pharmaceutical leader, has contributed significantly to antifungal research, including oral treatments for onychomycosis. Its clinical efforts in nail fungal infections focus on broad-spectrum efficacy and improved safety profiles. Pfizer continues to evaluate novel mechanisms and optimised dosing strategies for treating difficult-to-eradicate nail pathogens.
Other key players in the market include Bayer AG, Cipla Inc., and Novartis AG.
Reasons To Purchase This Report
The onychomycosis pipeline analysis report provides essential insights into the latest developments and future trends in the treatment of onychomycosis. It includes comprehensive evaluations of emerging therapies, an in-depth pipeline assessment, and a thorough competitive landscape analysis, empowering informed investment decisions and effective strategic planning.
Key Questions Answered in the Onychomycosis Pipeline Analysis Report
1. What are the latest advancements in onychomycosis therapies?
2. Which companies are leading the onychomycosis drug pipeline?
3. What are the key drug classes in onychomycosis treatment?
4. What are the regulatory trends influencing onychomycosis drug development?
5. How do emerging therapies impact on onychomycosis patient outcomes?
6. What are the market drivers for onychomycosis therapies?
7. What challenges do companies face in developing Onychomycosis drugs?
8. How do industry collaborations accelerate onychomycosis drug development?
9. Which treatments are expected to emerge in the onychomycosis pipeline?
10. What are the competitive dynamics in the onychomycosis market?
1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Onychomycosis
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Onychomycosis
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Onychomycosis: Epidemiology Snapshot
5.1 Onychomycosis Incidence by Key Markets
5.2 Onychomycosis - Patients Seeking Treatment in Key Markets
6 Onychomycosis: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Onychomycosis: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Onychomycosis, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 EMR Drug Pipeline Comparative Analysis
9.1 List of Onychomycosis Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Onychomycosis Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: MOB015B
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Other Drugs
11 Onychomycosis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: ATB1651-102
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Other Drugs
12 Onychomycosis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug 1
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Other Drugs
13 Onychomycosis Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Onychomycosis, Key Drug Pipeline Companies
14.1 Moberg Pharma AB
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 AmtixBio Co., Ltd.
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Hallux, Inc.
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Bausch Health Companies Inc.
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Pfizer Inc.
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 Bayer AG
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Cipla Inc.
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Novartis AG
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region
16 Terminated or Suspended Pipeline Products
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