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Oral Mucositis Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102739
Oral mucositis is a painful condition characterized by inflammation of the oral mucosa, often caused by antineoplastic therapies such as chemotherapy and radiation. It affects 40% to 100% of patients undergoing these treatments. Despite current treatment options like mouth rinses, analgesics, and topical therapies, there remains a significant unmet clinical need for more effective therapies. The growing focus on targeted therapeutics and novel oral mucositis drug candidates is likely to drive pipeline growth and improve patient outcomes in the coming years.

Report Coverage

The Oral Mucositis Drug Pipeline Insight Report by the publisher gives comprehensive insights into oral mucositis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for oral mucositis. The oral mucositis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The oral mucositis 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 oral mucositis 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 oral mucositis.

Oral Mucositis Drug Pipeline Outlook

Oral mucositis is a painful inflammation of the oral mucosa, often resulting from cancer treatments such as chemotherapy or radiation. It leads to painful sores, difficulty eating, and increased risk of infection. It occurs when chemotherapy or radiation damages rapidly dividing cells in the mouth, triggering inflammation and ulceration.

Oral mucositis treatments focus on improving pain and promoting healing. Current treatments include topical analgesics, mouth rinses, cryotherapy, and corticosteroids. However, their efficacy is limited, and ongoing research into novel drug candidates aims to provide better solutions, potentially leading to more targeted, effective treatments in the future.

Oral Mucositis Epidemiology

Oral mucositis primarily affects patients undergoing chemotherapy, radiotherapy, or hematopoietic stem cell transplants (HSCT). Globally, it impacts 40% of chemotherapy patients and 60%-85% of those undergoing high-dose chemotherapy for bone marrow transplants. For patients receiving combined chemo- and radiotherapy for head and neck cancers, oral mucositis prevalence can reach 90%, with 19% requiring hospitalization.

Oral Mucositis - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of oral mucositis 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
  • Immunotherapies

By Route of Administration

  • Oral
  • Parenteral
  • Others

Oral Mucositis - 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 covers a major share of the total oral mucositis clinical trials.

Oral Mucositis - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the oral mucositis pipeline analysis include small molecules, monoclonal antibodies, and immunotherapies. The oral mucositis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for oral mucositis.

Oral Mucositis Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report on the oral mucositis drug pipeline covers the profiles of key companies involved in clinical trials and their drugs under development. It provides a detailed oral mucositis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in oral mucositis clinical trials:
  • EpicentRx, Inc.
  • Tosk, Inc.
  • MitoImmune Therapeutics
  • SIRO Clinpharm Pvt. Ltd.
  • CelaCare Technologies, Inc.
  • Matrix Biomed, Inc.
  • Novo Nordisk
  • Zhejiang Echon Biopharm Ltd.

Oral Mucositis - 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 oral mucositis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of oral mucositis drug candidates.

Drug: Curcumin Lozenges

The Phase III randomized, double-blind, placebo-controlled study of curcumin lozenges, sponsored by Tata Memorial Centre, aims to assess the ability of curcumin to reduce the incidence and duration of oral mucositis in patients undergoing autologous stem cell transplantation. The study is expected to be completed by May 2025, with an enrollment of approximately 190 participants.

Drug: RRx-001

The Phase 2 clinical study, sponsored by EpicentRx, Inc., aims to evaluate the effectiveness of RRx-001 in reducing severe oral mucositis in patients undergoing chemotherapy and radiation for head and neck cancer. The study is expected to be completed by October 2025, with an estimated 216 participants. Participants will receive RRx-001 or a placebo in addition to standard treatment with cisplatin and radiation.

Drug: N-acetylcysteine

The drug N-acetylcysteine, sponsored by Mansoura University, is being studied in a Phase 2 clinical trial to assess its efficacy in preventing radiotherapy-induced oral mucositis in head and neck cancer patients. The study aims to evaluate its safety and effectiveness alongside standard care. The study is expected to be completed by March 2025 with an enrollment of around 50 participants.

Reasons To Buy This Report

The Oral Mucositis Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for oral mucositis. 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 oral mucositis collaborations, regulatory environments, and potential growth opportunities.

Key Questions Answered in the Oral Mucositis - Pipeline Insight Report

  • Which companies/institutions are leading the oral mucositis drug development?
  • What is the efficacy and safety profile of oral mucositis pipeline drugs?
  • Which company is leading the oral mucositis pipeline development activities?
  • What is the current oral mucositis commercial assessment?
  • What are the opportunities and challenges present in the oral mucositis drug pipeline landscape?
  • What is the efficacy and safety profile of oral mucositis pipeline drugs?
  • Which company is conducting major trials for oral mucositis drugs?
  • Which companies/institutions are involved in oral mucositis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in oral mucositis?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Oral Mucositis
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Oral Mucositis
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Oral Mucositis: Epidemiology Snapshot
5.1 Oral Mucositis Incidence by Key Markets
5.2 Oral Mucositis - Patients Seeking Treatment in Key Markets
6 Oral Mucositis: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Oral Mucositis: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Oral Mucositis, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Oral Mucositis Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Oral Mucositis Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: Curcumin Lozenges
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Other Drugs
11 Oral Mucositis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: RRx-001
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Drug: N-Acetyl- Cysteine
11.2.3 Other Drugs
12 Oral Mucositis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug 1
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Other Drugs
13 Oral Mucositis Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Oral Mucositis, Key Drug Pipeline Companies
14.1 EpicentRx, Inc.
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Tosk, Inc.
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 MitoImmune Therapeutics
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 SIRO Clinpharm Pvt. Ltd.
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 CelaCare Technologies, Inc.
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 Matrix Biomed, Inc.
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Novo Nordisk
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Zhejiang Echon Biopharm Ltd.
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products