Stomatitis - Pipeline Insight, 2025

This “Stomatitis - Pipeline Insight, 2025,” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Stomatitis 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.

Stomatitis Understanding

Stomatitis: Overview

Stomatitis refers to inflammation of the mucous membrane of the mouth, including the inner aspect of the lips, cheeks, gums, tongue and throat. It is a type of mucositis. It can be acute or chronic, mild or serious. Stomatitis results in pain, stinging and soreness. It can present with: Red patches, Mouth ulcers, Blisters, Peeling, Swelling, Oral dysaesthesia (numbness), Burning mouth syndrome - soreness despite normal appearance. Stomatitis can be due to injury, infection, and allergy, systemic or skin disease. Many cases of stomatitis, especially canker sores or cold sores, can be diagnosed through a physical exam and a medical history including a history of symptoms. Some cases of stomatitis - such as a mild case of canker sores - require no treatment. If treatment is required for stomatitis, it will depend on the underlying cause. Treatment for the condition includes: over-the-counter (OTC) pain relievers such as acetaminophen or ibuprofen, topical medications that help with pain or inflammation, drinking more fluids to keep the mucous membranes well hydrated, mouthwashes such as salt water (alcohol-based mouthwash should be avoided), antiviral creams for cold stores are available over-the-counter.

'Stomatitis - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Stomatitis pipeline landscape is provided which includes the disease overview and Stomatitis treatment guidelines. The assessment part of the report embraces, in depth Stomatitis 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, Stomatitis 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 Stomatitis R&D. The therapies under development are focused on novel approaches to treat/improve Stomatitis.

Stomatitis Emerging Drugs Chapters

This segment of the Stomatitis 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.

Stomatitis Emerging Drugs

GC4419: Galera Therapeutics

GC4419, also known as avasopasem manganese, has successfully completed two clinical trials in which it was evaluated for reduction of severe oral mucositis in patients with head and neck cancer undergoing radiation therapy and also receiving cisplatin, a chemotherapy drug. Avasopasem is designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen, protecting normal tissue from damage associated with radiation therapy. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. It is currently being investigated in phase III clinical trials for stomatitis.

EC-18: Enzychem Lifesciences

EC-18 is an immune modulator, which has an unique mechanism of action called PETA (Pattern Recognition Receptor Endocytic Trafficking Accelerator) which accelerates the PRR-mediated endocytosis, endosome formation, ROS generation and recycle of PRRs such as TLR3, 4 and 7 etc. so that EC-18 shortens the duration of inflammatory immune response by quickly removing the PAMP/DAMP associated danger signals. As a result of the early termination of immune response, EC-18 contributes the rapid resolution of inflammation and early return to homeostasis. The clinical trials for EC-18 are in phase II stage for the treatment of patients with chemo radiation induced oral mucositis.

Stomatitis: Therapeutic Assessment

This segment of the report provides insights about the different Stomatitis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Stomatitis

There are approx. 15+ key companies which are developing the therapies for Stomatitis. The companies which have their Stomatitis drug candidates in the most advanced stage, i.e. Phase III include, Galera Therapeutics.

Phases

The 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

Stomatitis 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
• Intravenous
• 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.

Stomatitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Stomatitis 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 Stomatitis drugs.

Stomatitis Report Insights

• Stomatitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Stomatitis 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 Stomatitis drugs?
• How many Stomatitis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Stomatitis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Stomatitis 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 Stomatitis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• EpicentRx, Inc.

Monopar Therapeutics

• Galera Therapeutics, Inc.

Enzychem Lifesciences Corporation

• Soligenix
• MitoImmune Therapeutics

Key Products

• RRx-001
• Clonidine HCl
• GC4419
• EC 18
• SGX942
• MIT-001

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