Onychomycosis Pipeline Analysis Report 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?