Onychomycosis - Pipeline Insight, 2024

This “Onychomycosis - Pipeline Insight, 2024,” report provides comprehensive insights about 15+ companies and 15+ 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.

Geography Covered

• Global coverage

Onychomycosis Understanding

Onychomycosis: Overview

Onychomycosis is fungal infection of the nail plate, nail bed, or both. The nails typically are deformed and discolored white or yellow. Diagnosis is by appearance, wet mount, culture, polymerase chain reaction, or a combination. Treatment, when indicated, is with oral terbinafine or itraconazole. Onychomycosis is suspected by appearance in patients who also have tinea pedis; predictive clinical features include involvement of the 3rd or 5th toenail, involvement of the 1st and 5th toenails on the same foot, and unilateral nail deformity. Subclinical onychomycosis should be considered in patients with recurrent tinea pedis.

Onychomycosis - Pipeline Insight, 2024 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 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

MOB-015: Moberg PharmaMOB-015 is an internally developed topical formulation of terbinafine based on Moberg Pharma’s experience from previously having developed and commercialized a leading OTC product for onychomycosis. MOB-015 has recently been evaluated over 52 weeks in two randomized, multicenter, controlled Phase III studies, including in total more than 800 patients in North America and Europe. The primary endpoint was met in both studies, the proportion of patients achieving complete cure of their target nail.Moberg Pharma AB (publ) have submitted its marketing authorization application for MOB-015 (nail fungus treatment). The company has submitted the application in Europe through the decentralized procedure, and market approval is expected in 2023.

BB2603: Blueberry TherapeuticsBlueberry 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.

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. 15+ key companies which are developing the therapies for Onychomycosis. The companies which have their Onychomycosis drug candidates in the most advanced stage, i.e. Preregistration include, Moberg Pharma.

Phases

This report covers around 15+ 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

• Oral
• Parenteral
• intradermal
• Subcutaneous
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

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

• Moberg Pharma
• Blueberry Therapeutics
• DermBiont
• Sanotize Research and Development
• Meiji Seika Pharma
• NovaBiotics
• Polichem
• Hallux
• Hexima
• Turn Therapeutics
• 9305-9954 Quebec
• Mycovia Pharmaceuticals
• CSA BioTech
• Kaken Pharmaceutical
• Turn Therapeutics

Key Products

• MOB-015
• BB-2603
• DBI 001
• NORS 6491
• NP 213
• ALM-12834
• HTS-519
• HXP 124
• GX-03
• CELEXT 07
• VT-1161
• KP-607

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