This “Onychomycosis - Pipeline Insight, 2025” report provides comprehensive insights about 11+ companies and 11+ pipeline drugs in Onychomycosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
The most common signs include discoloration of the nail bed and surrounding skin, which can appear white or yellow. Dry or scaly skin around the nail is another common indication, often accompanied by a foul smell. Histologically, the acute lesion of onychomycosis exhibits spongiosis, acanthosis, papillomatosis with edema, and hyperkeratosis. At the chronic stage, large amounts of compact hyperkeratosis, hypergranulosis, acanthosis, and papillomatosis with sparse perivascular infiltrate are observed. The infection can also lead to various clinical presentations, such as distal lateral subungual onychomycosis (DSLO), which involves partial distal onycholysis with subungual hyperkeratosis or crumbling, and white superficial onychomycosis (WSO), characterized by white, chalky deposits on the nail plate that can be easily scraped away.
The choice of treatment depends on the clinical type of the infection, the number of affected nails, and the severity of nail involvement. Systemic therapy with oral antifungals like fluconazole and posaconazole is often necessary for proximal subungual and distal lateral subungual onychomycosis. Topical antifungals like ciclopirox olamine and efinaconazole can be used for less severe cases or as adjunctive therapy in combination with oral therapy. Photodynamic therapy and lasers may represent future treatment options. Treatment duration can be prolonged, and recurrence rates remain high even with newer agents. Therefore, the decision to treat should be made with a clear understanding of the cost, risks, and potential for recurrence. Additionally, laboratory diagnosis and antifungal susceptibility testing are essential for accurate diagnosis and effective management of onychomycosis, especially in cases of nondermatophyte molds and mixed infections.
'Onychomycosis - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Onychomycosis pipeline landscape is provided which includes the disease overview and Onychomycosis treatment guidelines. The assessment part of the report embraces, in depth Onychomycosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Onychomycosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
This product will be delivered within 2 business days.
Onychomycosis: Understanding
Onychomycosis: Overview
Onychomycosis is a fungal infection of the nail, typically caused by dermatophytes, which affects approximately 10% of the US population. The disease can have significant negative consequences for patients, including pain, discomfort, and potential impacts on work and social lives. The primary pathogens responsible for onychomycosis are dermatophytes, such as Trichophyton rubrum, Epidermophyton floccosum, and Trichophyton mentagrophytes. Other organisms, including yeasts like Candida albicans and nondermatophyte molds, can also be implicated. The infection can manifest in various forms, including distal subungual onychomycosis, which is the most common type, characterized by invasion of the nail bed and underside of the nail plate.The most common signs include discoloration of the nail bed and surrounding skin, which can appear white or yellow. Dry or scaly skin around the nail is another common indication, often accompanied by a foul smell. Histologically, the acute lesion of onychomycosis exhibits spongiosis, acanthosis, papillomatosis with edema, and hyperkeratosis. At the chronic stage, large amounts of compact hyperkeratosis, hypergranulosis, acanthosis, and papillomatosis with sparse perivascular infiltrate are observed. The infection can also lead to various clinical presentations, such as distal lateral subungual onychomycosis (DSLO), which involves partial distal onycholysis with subungual hyperkeratosis or crumbling, and white superficial onychomycosis (WSO), characterized by white, chalky deposits on the nail plate that can be easily scraped away.
The choice of treatment depends on the clinical type of the infection, the number of affected nails, and the severity of nail involvement. Systemic therapy with oral antifungals like fluconazole and posaconazole is often necessary for proximal subungual and distal lateral subungual onychomycosis. Topical antifungals like ciclopirox olamine and efinaconazole can be used for less severe cases or as adjunctive therapy in combination with oral therapy. Photodynamic therapy and lasers may represent future treatment options. Treatment duration can be prolonged, and recurrence rates remain high even with newer agents. Therefore, the decision to treat should be made with a clear understanding of the cost, risks, and potential for recurrence. Additionally, laboratory diagnosis and antifungal susceptibility testing are essential for accurate diagnosis and effective management of onychomycosis, especially in cases of nondermatophyte molds and mixed infections.
'Onychomycosis - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Onychomycosis pipeline landscape is provided which includes the disease overview and Onychomycosis treatment guidelines. The assessment part of the report embraces, in depth Onychomycosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Onychomycosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence Onychomycosis R&D. The therapies under development are focused on novel approaches to treat/improve Onychomycosis.Onychomycosis Emerging Drugs Chapters
This segment of the Onychomycosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/III, II, I, preclinical and discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.Onychomycosis Emerging Drugs
BB2603: Blueberry Therapeutics
Blueberry is developing a new topical antifungal spray formulation of terbinafine (BB2603‑om) for the treatment of onychomycosis using our nanodelivery platform technology. The aim is to apply the spray directly to the nail, and through enhanced delivery of the active substance through the nail, to match the cure rates of the more effective oral formulations in a topical medicine, without the associated safety concerns. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with Onychomycosis.ATB-1651: AmtixBio
ATB-1651 is a potential first-in-class drug candidate targeting fungal cell wall components. It is a new drug candidate that acts quickly on virulent fungi, can reliably kill fungi, and reliably suppresses the creation of resistant bacteria. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with Onychomycosis.Onychomycosis: Therapeutic Assessment
This segment of the report provides insights about the different Onychomycosis drugs segregated based on following parameters that define the scope of the report, such as:Major Players in Onychomycosis
There are approx. 11+ key companies which are developing the therapies for Onychomycosis. The companies which have their Onychomycosis drug candidates in the most advanced stage, i.e. Phase II include, Blueberry Therapeutics.Phases
The report covers around 11+ products under different phases of clinical development like
- Late stage products (Phase III)
- Mid-stage products (Phase II)
- Early-stage product (Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
Route of Administration
Onychomycosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as- Intravenous
- Subcutaneous
- Oral
- Intramuscular
Molecule Type
Products have been categorized under various Molecule types such as
- Monoclonal antibody
- Small molecule
- Peptide
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.Onychomycosis: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Onychomycosis therapeutic drugs key players involved in developing key drugs.Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Onychomycosis drugs.Onychomycosis Report Insights
- Onychomycosis Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
Onychomycosis Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Onychomycosis drugs?
- How many Onychomycosis drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Onychomycosis?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Onychomycosis therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Onychomycosis and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Blueberry Therapeutics
- AmtixBio
- Mycovia Pharmaceuticals
- Polichem
- Onicor
- Nihon Nohyaku
Key Products
- BB2603
- ATB-1651
- Oteseconazole
- P-3058
- Research programme
- Luliconazole
This product will be delivered within 2 business days.
Table of Contents
IntroductionExecutive SummaryOnychomycosis- The Publisher's Analytical PerspectiveOnychomycosis Key CompaniesOnychomycosis Key ProductsOnychomycosis- Unmet NeedsOnychomycosis- Market Drivers and BarriersOnychomycosis- Future Perspectives and ConclusionOnychomycosis Analyst ViewsOnychomycosis Key CompaniesAppendix
Onychomycosis: Overview
Pipeline Therapeutics
Therapeutic Assessment
Late Stage Products (Phase III)
Drug name: Company name
Mid Stage Products (Phase II)
BB2603: Blueberry Therapeutics
Early Stage Products (Phase I)
ATB-1651: AmtixBio
Preclinical and Discovery Stage Products
Drug name: Company name
Inactive Products
List of Table
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Blueberry Therapeutics
- AmtixBio
- Mycovia Pharmaceuticals
- Polichem
- Onicor
- Nihon Nohyaku
