Onychomycosis, a fungal infection affecting the nails, impacts 1% to 8% of the general population and 19% to 51.9% of patients undergoing hemodialysis. There is a significant unmet clinical need for advanced onychomycosis therapeutics, as current treatment options, such as oral antifungals and topical agents, often exhibit limited efficacy and prolonged treatment durations. The growing focus on innovative drug delivery systems, targeted therapies, and antifungal agents with improved safety profiles is expected to accelerate the development of onychomycosis drug candidates. According to the onychomycosis pipeline analysis by the publisher, these advancements aim to address the existing gaps in treatment and improve patient outcomes in the coming years.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to onychomycosis.
Onychomycosis is typically treated with oral antifungals, such as terbinafine or itraconazole, and topical formulations like ciclopirox or efinaconazole. However, treatment duration is often long, with variable efficacy and potential side effects. Recent advancements focus on targeted therapeutics, improved drug delivery systems, and shorter treatment regimens, aiming to enhance outcomes and address the limitations of existing therapies. Emerging therapies in the pipeline hold promise for better management of the condition. In January 2024, Vanda Pharmaceuticals received approval from the U.S. Food and Drug Administration to initiate clinical trials for VTR-297, a novel topical antifungal candidate for onychomycosis. VTR-297 is a small molecule histone deacetylase inhibitor with antifungal activity, originally derived from Streptomyces hygroscopicus. It targets dermatophytes and fungi, offering a potential new treatment option for nail fungal infections, which have seen limited therapeutic advancements.
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Report Coverage
The Onychomycosis Pipeline Analysis Report by the publisher gives comprehensive insights into onychomycosis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for onychomycosis. The onychomycosis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The onychomycosis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with onychomycosis treatment guidelines to ensure optimal care practices.The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to onychomycosis.
Onychomycosis Pipeline Outlook
Onychomycosis is a fungal infection of the nails caused by dermatophytes, yeasts, or non-dermatophyte molds. It occurs due to factors like prolonged exposure to moist environments, trauma to the nails, or underlying conditions such as diabetes. The infection leads to nail discoloration, thickening, and brittleness, significantly affecting patients’ quality of life.Onychomycosis is typically treated with oral antifungals, such as terbinafine or itraconazole, and topical formulations like ciclopirox or efinaconazole. However, treatment duration is often long, with variable efficacy and potential side effects. Recent advancements focus on targeted therapeutics, improved drug delivery systems, and shorter treatment regimens, aiming to enhance outcomes and address the limitations of existing therapies. Emerging therapies in the pipeline hold promise for better management of the condition. In January 2024, Vanda Pharmaceuticals received approval from the U.S. Food and Drug Administration to initiate clinical trials for VTR-297, a novel topical antifungal candidate for onychomycosis. VTR-297 is a small molecule histone deacetylase inhibitor with antifungal activity, originally derived from Streptomyces hygroscopicus. It targets dermatophytes and fungi, offering a potential new treatment option for nail fungal infections, which have seen limited therapeutic advancements.
Onychomycosis Epidemiology
Onychomycosis affects 1% to 8% of the global population and 19% to 51.9% of hemodialysis patients. In India, the prevalence ranges from 0.5% to 5%, with dermatophytes causing 90% of cases in the United States and Europe. The rising incidence, especially among diabetic and immunocompromised populations, highlights the urgent need for advanced onychomycosis drug candidates.Onychomycosis Pipeline Therapeutic Assessment
This section of the report covers the analysis of onychomycosis drug candidates based on several segmentations, including:By Phase
The pipeline report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
The onychomycosis pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Peptides
- Gene Therapies
By Route of Administration
The assessment report covers 50+ drug analyses based on the route of administration.- Oral
- Parenteral
- Others
Onychomycosis - Pipeline Assessment Segmentation, By Phases
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 analysis, phase II and phase IV at 33.33% each, cover a major share of the total onychomycosis clinical trials. demonstrates a strong developmental focus and significant post-marketing evaluations, ensuring long-term safety and effectiveness. Phase I and Phase III each account for 16.67%, indicating early and late-stage innovations. This balanced pipeline can positively impact the onychomycosis market by advancing treatment options and enhancing patient outcomes.Onychomycosis Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the onychomycosis pipeline analysis include small molecules, monoclonal antibodies, peptides, and gene therapies. The onychomycosis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for onychomycosis. Antifungal-based therapies for onychomycosis are gaining prominence in the drug pipeline to improve treatment outcomes. For instance, Efinaconazole 10% solution, an azole antifungal, is under evaluation for both adult and pediatric patients. Additionally, novel topical formulations and combination regimens are being investigated to enhance nail penetration and minimize systemic exposure.Onychomycosis Clinical Trials Therapeutic Assessment - Competitive Dynamics
The report for the onychomycosis pipeline covers the profiles of key companies involved in clinical trials and their drugs under development. It provides a detailed onychomycosis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is a list of a few players involved in onychomycosis clinical trials:- Moberg Pharma AB
- AmtixBio Co., Ltd.
- Hallux, Inc.
- Bausch Health Companies Inc.
- Pfizer Inc.
- Bayer AG
- Cipla Inc.
- Novartis AG
Onychomycosis Emerging Drugs Profile
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for onychomycosis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of onychomycosis drug candidates.Drug: MOB015B
A Phase 3 multicenter, double-blind study, sponsored by Moberg Pharma AB, aims to evaluate the efficacy and safety of topical MOB015B for treating distal subungual onychomycosis (DSO). With an estimated enrollment of 350 participants, the study involves an 8-week daily treatment followed by a 40-week weekly regimen. MOB-015 delivers concentrated terbinafine topically to the nail and nail bed, optimizing local efficacy while significantly reducing systemic exposure for onychomycosis treatment.Drug: ATB1651-102
ATB1651, sponsored by AmtixBio Co., Ltd. is in a Phase 2 study that aims to evaluate the safety, tolerability, and pharmacokinetics of ATB1651 in adults with mild to moderate onychomycosis. This randomized, double-blind, placebo-controlled trial will enroll approximately 120 participants. The study is expected to complete primary data collection by June 30, 2025, with overall completion by January 30, 2026. ATB1651 gel enhances antifungal activity by modifying aryl rings, alkyl chains, and methyl groups, disrupting fungal cell membranes and inhibiting growth.Key Questions Answered in the Onychomycosis - Pipeline Insight Report
- Which companies/institutions are leading the onychomycosis drug development?
- What is the efficacy and safety profile of onychomycosis pipeline drugs?
- Which company is leading the onychomycosis pipeline development activities?
- What is the current onychomycosis commercial assessment?
- What are the opportunities and challenges present in the onychomycosis pipeline landscape?
- What is the efficacy and safety profile of onychomycosis pipeline drugs?
- Which company is conducting major trials for onychomycosis drugs?
- Which companies/institutions are involved in onychomycosis collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in onychomycosis?
Reasons To Buy This Report
The Onychomycosis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for onychomycosis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into onychomycosis collaborations, regulatory environments, and potential growth opportunities.This product will be delivered within 3-5 business days.
Table of Contents
1 Preface
3 Overview of Onychomycosis
4 Patient Profile: Onychomycosis
5 Onychomycosis: Epidemiology Snapshot
6 Onychomycosis: Market Dynamics
7 Onychomycosis: Key Facts Covered
8 Onychomycosis, Drug Pipeline Assessment
9 Drug Pipeline Comparative Analysis
10 Onychomycosis Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
11 Onychomycosis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
12 Onychomycosis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
13 Onychomycosis Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
14 Onychomycosis, Key Drug Pipeline Companies
