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Dusquetide

Phase 3

Behçet Disease | Small molecule | Immunology |Soligenix, Inc.|Trials Updated: Aug 26, 2026

Dusquetide development status

Highest phase Phase 3 (NCT03237325)
Phase scored for SNGXPhase 2
Registered trials 3 across 1 sponsor since Dec 2013

Dusquetide target and mechanism

Target class-Tide (Peptide)
ModalitySmall molecule

Also known as SGX945, SGX942

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment385

FDA Designations

No designations recorded

Dusquetide clinical trials

Dusquetide · 3 trials · 3 indications

Phase 3 1Phase 2 2
NCT03237325DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck CancerSquamous Cell Carcinoma of the Oral Cavity and Oropharynx
COMPLETED266 Analytics
PHASE3COMPLETED
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Squamous Cell Carcinoma of the Oral Cavity and OropharynxUnlock trial analytics

Study Endpoints

Primary Endpoints

Duration of Severe Oral Mucositis (SOM)
approx. 13 weeks

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.

Number of Oral Ulcers
4 weeks

The number of oral ulcers were counted at baseline and each visit during the treatment period.

Number of Genital Ulcers
4 weeks

The number of genital ulcers will be counted at baseline and each visit during the treatment period.

Secondary Endpoints

Change in Pain of Oral Ulcers From Baseline to End of Treatment
4 weeks
Change in Pain of Genital Ulcers From Baseline to End of Treatment
4 weeks
Residual Severe Oral Mucositis (SOM)
4 weeks after end of therapy
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SGX942EXPERIMENTALPatients are randomized 1:1 active/placebo.
PlaceboPLACEBO_COMPARATORPatients are randomized 1:1 active/placebo.
SGX945EXPERIMENTALThis is an open-label study and all participants will receive SGX945.

Interventions

NameTypeDescription
SGX942DRUG1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.
PlaceboDRUGPlacebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
DusquetideDRUG1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases * Scheduled to receive cisplatin chemotherapy of 80-100 mg/m² * Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiat...

Countries:United StatesBelgiumFranceSpainUnited KingdomTurkey (Türkiye)
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Recent Changes (Last 90 Days)

MEDIUMSep 26, 2026NCT06386744TRIAL_REMOVED: changed
MEDIUMSep 26, 2026NCT06386744TRIAL_REMOVED: changed
MEDIUMSep 26, 2026NCT06386744TRIAL_REMOVED: changed
MEDIUMSep 26, 2026NCT06386744TRIAL_REMOVED: changed

Frequently asked questions about Dusquetide

What is Dusquetide used for?

Dusquetide is being developed for the treatment of Behçet Disease, an inflammatory condition. It is an investigational small molecule studied by Soligenix, Inc. in a Phase 2 clinical trial. It has not been approved for commercial use, and its study in Behçet Disease remains at the clinical development stage.

Who is developing Dusquetide?

Dusquetide is being developed by Soligenix, Inc., a biopharmaceutical company that trades under the ticker symbol SNGX. Soligenix sponsored the Phase 2 clinical trial evaluating Dusquetide in patients with Behçet Disease.

What phase is Dusquetide in?

Dusquetide is in Phase 2 clinical development for Behçet Disease. The completed Phase 2 trial, NCT06386744, enrolled 8 participants. Dusquetide is investigational and has not been approved by the FDA for any indication.

What clinical trials is Dusquetide in?

Dusquetide has been studied in one clinical trial, NCT06386744, titled "Dusquetide for the Treatment of Behcet's Disease." This Phase 2 trial was completed and enrolled 8 participants in Turkey. It was an uncontrolled study without randomization or double-blinding, and participants were 18 years or older.

How does Dusquetide work?

Dusquetide is a small molecule in the peptide class, often referred to by the suffix -tide. It is being evaluated for its activity in Behçet Disease, an immune-mediated inflammatory condition. Its precise molecular target has not been publicly characterized in the available clinical data.