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Oral Mucositis

9
Pipeline Programs
21
Companies
19
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
7
0
0
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 20 programs with unclassified modality

Competitive Landscape

20 companies ranked by most advanced pipeline stage

Design Pharmaceuticals
1 program
1
Low intensity laser for oral mucositisPhase 4
Oragenics
OragenicsLAKEWOOD RANCH, FL
1 program
1
AG013Phase 21 trial
Active Trials
NCT03234465Terminated200Est. Jul 2020
CSL Seqirus
CSL SeqirusUK - Maidenhead
1 program
1
ALD518Phase 2
Valerio Therapeutics
Valerio TherapeuticsFrance - Paris
1 program
1
Clonidine Lauriad® 50µgPhase 21 trial
Active Trials
NCT01385748Completed183Est. Dec 2014
Biocorp
BiocorpFrance - Issoire
1 program
1
Faringel plus and oral hygienePhase 21 trial
Active Trials
NCT04911335Completed77Est. Nov 2022
Mitoimmune Therapeutics
1 program
1
MIT-001Phase 21 trial
Active Trials
NCT05493800Active Not Recruiting60Est. Dec 2024
SciClone Pharmaceuticals
SciClone PharmaceuticalsChina - Shanghai
1 program
1
SCV-07Phase 21 trial
Active Trials
NCT01247246Unknown160Est. Jun 2014
Pfizer
PfizerNEW YORK, NY
1 program
1
celecoxibPhase 2Small Molecule1 trial
Active Trials
NCT00698204Completed43Est. Dec 2013
Biomed
BiomedAustralia - Sydney
1 program
1
Melatonin oral gel 3%Phase 1/21 trial
Active Trials
NCT02630004Completed84Est. Dec 2017
EpicentRx
EpicentRxCA - La Jolla
2 programs
RRx-001PHASE_21 trial
RRx-001PHASE_21 trial
Active Trials
NCT05966194Recruiting216Est. Oct 2025
NCT03515538Completed53Est. Oct 2020
Martin Pharmaceuticals
1 program
Control GroupN/A1 trial
Active Trials
NCT00804817Completed84Est. Aug 2010
Tissue Repair
Tissue RepairAustralia - Sydney
1 program
MUCIPLIQN/A1 trial
Active Trials
NCT01840436Completed136Est. Jan 2015
Stuart Therapeutics
1 program
OM Pain AppN/A1 trial
Active Trials
NCT02727062Terminated18Est. Aug 2019
Camurus
CamurusSweden - Lund
1 program
episilN/A1 trial
Active Trials
NCT01684566Completed116Est. Sep 2013
Swedish Orphan Biovitrum
1 program
PaliferminPHASE_11 trial
Active Trials
NCT01163097Completed44Est. Jan 2011
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
1 program
CaphosolPHASE_1_21 trial
Active Trials
NCT00901732Unknown100Est. Nov 2010
CSL Behring
CSL BehringIL - Bradley
1 program
ALD518PHASE_21 trial
Active Trials
NCT01403064Terminated76Est. Mar 2014
Soligenix
SoligenixPRINCETON, NJ
1 program
SGX942PHASE_21 trial
Active Trials
NCT02013050Completed111Est. Sep 2016
Celldex Therapeutics
1 program
velaferminPHASE_21 trial
Active Trials
NCT00323518Completed390Est. Aug 2008
Design Therapeutics
1 program
Low intensity laser for oral mucositisPHASE_41 trial
Active Trials
NCT01876407Unknown126Est. Jul 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Design TherapeuticsLow intensity laser for oral mucositis
EpicentRxRRx-001
Mitoimmune TherapeuticsMIT-001
BiocorpFaringel plus and oral hygiene
EpicentRxRRx-001
OragenicsAG013
SoligenixSGX942
CSL BehringALD518
SciClone PharmaceuticalsSCV-07
Valerio TherapeuticsClonidine Lauriad® 50µg
Celldex Therapeuticsvelafermin
Pfizercelecoxib
BiomedMelatonin oral gel 3%
Jazz PharmaceuticalsCaphosol
Swedish Orphan BiovitrumPalifermin

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 2,277 patients across 19 trials

NCT01876407Design TherapeuticsLow intensity laser for oral mucositis

Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer

Start: Jan 2013Est. completion: Jul 2016126 patients
Phase 4Unknown
NCT05966194EpicentRxRRx-001

RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

Start: Apr 2024Est. completion: Oct 2025216 patients
Phase 2Recruiting
NCT05493800Mitoimmune TherapeuticsMIT-001

Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

Start: Feb 2022Est. completion: Dec 202460 patients
Phase 2Active Not Recruiting
NCT04911335BiocorpFaringel plus and oral hygiene

Propolis-based Product (FARINGEL PLUS) for Oral Mucositis in Palliative Care

Start: Jul 2021Est. completion: Nov 202277 patients
Phase 2Completed
NCT03515538EpicentRxRRx-001

Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

Start: Jul 2018Est. completion: Oct 202053 patients
Phase 2Completed
NCT03234465OragenicsAG013

Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day

Start: Jul 2017Est. completion: Jul 2020200 patients
Phase 2Terminated
NCT02013050SoligenixSGX942

A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

Start: Dec 2013Est. completion: Sep 2016111 patients
Phase 2Completed
NCT01403064CSL BehringALD518

Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

Start: Jul 2011Est. completion: Mar 201476 patients
Phase 2Terminated
NCT01247246SciClone PharmaceuticalsSCV-07

Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

Start: Dec 2010Est. completion: Jun 2014160 patients
Phase 2Unknown
NCT01385748Valerio TherapeuticsClonidine Lauriad® 50µg

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis

Start: Apr 2010Est. completion: Dec 2014183 patients
Phase 2Completed
NCT00323518Celldex Therapeuticsvelafermin

A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

Start: May 2006Est. completion: Aug 2008390 patients
Phase 2Completed
NCT00698204Pfizercelecoxib

Cox-2 Inhibition in Radiation-induced Oral Mucositis

Start: Jul 2003Est. completion: Dec 201343 patients
Phase 2Completed
NCT02630004BiomedMelatonin oral gel 3%

Melatonin Oral Gel for Oral Mucositis in Patients With Head and Neck Cancer Undergoing Chemoradiation

Start: Nov 2015Est. completion: Dec 201784 patients
Phase 1/2Completed
NCT00901732Jazz PharmaceuticalsCaphosol

Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Start: May 2009Est. completion: Nov 2010100 patients
Phase 1/2Unknown
NCT01163097Swedish Orphan BiovitrumPalifermin

Study to Characterize the Effect of Heparin on Palifermin Activity

Start: Jul 2010Est. completion: Jan 201144 patients
Phase 1Completed
NCT02727062Stuart TherapeuticsOM Pain App

Smartphone Pain App for Assessing Oral Mucositis Pain in Patients

Start: Feb 2018Est. completion: Aug 201918 patients
N/ATerminated
NCT01840436Tissue RepairMUCIPLIQ

Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer

Start: Mar 2013Est. completion: Jan 2015136 patients
N/ACompleted
NCT01684566Camurusepisil

A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis

Start: Feb 2013Est. completion: Sep 2013116 patients
N/ACompleted
NCT00804817Martin PharmaceuticalsControl Group

Somatic-psychosocial Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

Start: Dec 2007Est. completion: Aug 201084 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 actively recruiting trials targeting 2,277 patients
21 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.