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Stomatitis

3
Pipeline Programs
6
Companies
6
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
keratinocyte growth factorPhase 31 trial
Active Trials
NCT00038792Terminated7Est. Jan 2003
Enzychem Lifesciences
1 program
1
EC-18Phase 21 trial
Active Trials
NCT03200340Completed105Est. May 2021
Sandoz
SandozAustria - Kundl
1 program
1
Miracle Mouthwash Plus HydrocortisonePhase 21 trial
Active Trials
NCT02229136Completed104Est. Nov 2022
Autonomous Therapeutics
1 program
Non-Thermal PlasmaN/A1 trial
Active Trials
NCT07322666Completed50Est. Feb 2024
Celldex Therapeutics
1 program
CG53135-05, velaferminPHASE_21 trial
Active Trials
NCT00104065CompletedEst. Dec 2005
Daiichi Sankyo
Daiichi SankyoChina - Shanghai
1 program
Dexamethasone mouthwashPHASE_41 trial
Active Trials
NCT07357597Not Yet Recruiting100Est. Oct 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Daiichi SankyoDexamethasone mouthwash
Enzychem LifesciencesEC-18
SandozMiracle Mouthwash Plus Hydrocortisone
Celldex TherapeuticsCG53135-05, velafermin
Amgenkeratinocyte growth factor
Autonomous TherapeuticsNon-Thermal Plasma

Clinical Trials (6)

Total enrollment: 366 patients across 6 trials

NCT07357597Daiichi SankyoDexamethasone mouthwash

An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -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.

Start: Feb 2026Est. completion: Oct 2027100 patients
Phase 4Not Yet Recruiting
NCT03200340Enzychem LifesciencesEC-18

EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation

Start: Jul 2018Est. completion: May 2021105 patients
Phase 2Completed
NCT02229136SandozMiracle Mouthwash Plus Hydrocortisone

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus

Start: Sep 2014Est. completion: Nov 2022104 patients
Phase 2Completed
NCT00104065Celldex TherapeuticsCG53135-05, velafermin

Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant

Start: Jan 2005Est. completion: Dec 2005
Phase 2Completed
NCT00038792Amgenkeratinocyte growth factor

Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD

Start: Oct 2000Est. completion: Jan 20037 patients
Phase 1/2Terminated
NCT07322666Autonomous TherapeuticsNon-Thermal Plasma

Non-Thermal Plasma vs. Low-Level Laser Therapy for Recurrent Oral Ulcers

Start: Feb 2019Est. completion: Feb 202450 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
6 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.