Back to discover
Disease
Stomatitis
Late-stage therapeutic developmentEmerging researchRising momentum
3
Publications
17
Clinical trials
12
Associated genes
2023
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Clinical trial2026-09-23Status changed to Completed · ClinicalTrials.gov
The Role of the Innate Immune Response in Oral Mucositis Pathogenesis.
Research2023-11-14International journal of molecular sciences
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Low
Key developments
- 4 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
- Q4 2026Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis
- Q1 2027A 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
- Q2 2027A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and/or Melphalan
- Q1 2028A 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)
Major developments
Upcoming trial readoutHigh impact
Results expected Q1 20282026-09-03
Upcoming trial readoutImportant
Results expected Q1 20272026-08-17
Clinical MilestonesViewHide
Results expected
- 2026-09-03A 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)Results expected Q1 2028
- 2026-08-17A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent ChemoradiationResults expected Q1 2027
- 2026-04-14A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and/or MelphalanResults expected Q2 2027
- 2026-02-17Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous StomatitisResults expected Q4 2026
Recently completed
Activity timeline5
- 2026-09-03ClinicalA 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)Results expected Q1 2028
- 2026-08-17ClinicalA Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent ChemoradiationResults expected Q1 2027
- 2026-04-14ClinicalA Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and/or MelphalanResults expected Q2 2027
- 2026-03-30ClinicalEvaluation of Zinc Oxide Ointment in Treatment of Recurrent Aphthous StomatitisCompleted
- 2026-02-17ClinicalRandomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous StomatitisResults expected Q4 2026
Clinical trials
The current development programme across all trial phases.
Clinical programme
17
4
8
6
Late-stage studies
Recruiting
Recently completed
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Publications over time
Most influential
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
Associated genes
Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP.
Identifiers
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.