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Disease

Stomatitis

Late-stage therapeutic developmentEmerging researchRising momentum
MeSHStomatitis
3
Publications
18
Clinical trials
2023
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

The Role of the Innate Immune Response in Oral Mucositis Pathogenesis.

Research2023-11-14International journal of molecular sciences

Oral mucositis: the hidden side of cancer therapy.

Research2020-10-07Journal of experimental & clinical cancer research : CR

Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.

Research2000-09-01The New England journal of medicine

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 5 clinical trials expected to report results, the earliest in Q3 2026.
Upcoming Milestones
Clinical Milestones6View
Results expected 5
Recently completed 1
Activity timeline6

Clinical trials

16 sponsors · 2 new · 1 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
18
All trials
5
Active
8
Late-stage
6
Completed
Late-stage studies

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

Phase 4 · Recruiting · AstraZeneca

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

Phase 3 · Recruiting · University Hospital, Rouen

Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis

Phase 4 · Completed · Faculty of Dental Medicine for Girls

Evaluating the Effectiveness of Topical Morphine Compared With a Routine Mouthwash in Managing Cancer Treatment-induced Mucositis in Patients With Head and Neck Cancer in Isfahan

Phase 2/3 · Completed · Isfahan University of Medical Sciences

The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Clinical Study With Biochemical Analysis

Phase 4 · Completed · Future University in Egypt

A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects With Radiation-Induced Mucositis

Phase 3 · Completed · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Recruiting

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

Phase 4 · Recruiting · AstraZeneca

Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis

Phase 3 · Recruiting · University Hospital, Rouen

FASTERCC: Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy. A Randomized, Double-blind Trial From the Danish Renal Cancer Group (DARENCA Study-4)

Phase 2 · Recruiting · Niels Fristrup

A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and/or Melphalan

Phase 2 · Recruiting · The First Affiliated Hospital of Soochow University

A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

Phase 2 · Recruiting · NRG Oncology
Recently completed

Evaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous Stomatitis

Phase 4 · Completed · Faculty of Dental Medicine for Girls

The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Clinical Study With Biochemical Analysis

Phase 4 · Completed · Future University in Egypt

A Pilot Study Evaluating the Efficacy of Apremilast in the Treatment of Subjects With Severe Recurrent Aphthous Stomatitis (RAS)

Phase 4 · Completed · Mayo Clinic

Treatment of Idiopathic and Recurrent Aphthous Stomatitis by a Probiotic, the Lactobacillus Rhamnosus Lcr35® : a Randomized, Double Blind and Placebo-controlled Trial

Phase 2 · Completed · Centre Hospitalier Universitaire de Nice

Evaluating the Effectiveness of Topical Morphine Compared With a Routine Mouthwash in Managing Cancer Treatment-induced Mucositis in Patients With Head and Neck Cancer in Isfahan

Phase 2/3 · Completed · Isfahan University of Medical Sciences

A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects With Radiation-Induced Mucositis

Phase 3 · Completed · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Research activity

3 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20002023
Most influential

Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.

The New England journal of medicine · 2000 · 2,062 cites

Oral mucositis: the hidden side of cancer therapy.

Journal of experimental & clinical cancer research : CR · 2020 · 273 cites

The Role of the Innate Immune Response in Oral Mucositis Pathogenesis.

International journal of molecular sciences · 2023 · 10 cites
Recent publications

The Role of the Innate Immune Response in Oral Mucositis Pathogenesis.

International journal of molecular sciences · 2023 · 10 cites

Oral mucositis: the hidden side of cancer therapy.

Journal of experimental & clinical cancer research : CR · 2020 · 273 cites

Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.

The New England journal of medicine · 2000 · 2,062 cites
Major themes4
  • Antineoplastic Agents1
  • Mucositis1
  • Quality of Life1
  • Stomatitis1
Leading journals3
  • International journal of molecular sciences1
  • Journal of experimental & clinical cancer research : CR1
  • The New England journal of medicine1
Leading researchers8
  • Ackland SP1
  • Blandino G1
  • Blanke C1
  • Bowen J1
  • Cox JV1
  • Cristaudo A1
  • Cross C1
  • Elfring GL1
Affiliations (unnormalised)6
  • Center for Complexity and Biosystems1
  • Memorial Sloan-Kettering Cancer Center1
  • Regina Elena National Cancer Institute1
  • SAFU Laboratory1
  • San Gallicano Dermatological Institute IRCCS1
  • San Gallicano Institute1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP.

Identifiers
MeSHStomatitis
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.