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Report Overview

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. These advancements aim to address the existing gaps in treatment and improve patient outcomes in the coming years.

  • Major companies involved in the onychomycosis pipeline drugs market include Moberg Pharma AB, AmtixBio Co., Ltd., and others.
  • Leading drugs currently in the pipeline include MOB015B, ATB1651-102, and others.
  • Due to rising disease prevalence, increased awareness, and advancements in treatment options, the onychomycosis drug pipeline is poised to grow in the near future.

Report Coverage

The Onychomycosis Drug Pipeline Insight Report by Expert Market Research 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 Drug 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.

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 Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of onychomycosis drug candidates based on several segmentations, including:

By 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

  • Small Molecules
  • Monoclonal Antibodies
  • Peptides
  • Gene Therapies

By 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 EMR analysis, phase II and phase IV cover a major share of the total onychomycosis clinical trials.

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.

Onychomycosis Clinical Trials Therapeutic Assessment – Competitive Dynamics

The EMR report for the onychomycosis drug 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.

Drug: ATB1651-102

AmtixBio Co., Ltd. is sponsoring 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.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Reasons To Buy This Report

The Onychomycosis Drug Pipeline Insight 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.

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 drug 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?

Related Reports

Onychomycosis Market

Global Nail Care Market

Global Clinical Trials Market

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Monoclonal Antibodies
  • Peptides
  • Gene Therapies

Leading Sponsors Covered

  • Moberg Pharma AB
  • AmtixBio Co., Ltd.
  • Hallux, Inc.
  • Bausch Health Companies Inc.
  • Pfizer Inc.
  • Bayer AG
  • Cipla Inc.
  • Novartis AG

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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