Dusquetide

Summary

Dusquetide (SGX942) is a first-in-class, synthetic 5-amino acid innate defense regulator peptide developed by Soligenix. It has been investigated primarily for the treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation therapy. By targeting the p62 scaffold protein, it modulates innate immunity to reduce excessive inflammation and promote tissue repair.

Mechanism of Action

Dusquetide is a synthetic innate defense regulator peptide that modulates the innate immune response by interacting with p62/sequestosome-1 (SQSTM1), a scaffold protein involved in NF-κB signaling and selective autophagy. It selectively suppresses excessive pro-inflammatory signaling while preserving or enhancing antimicrobial host defense mechanisms, thereby reducing inflammation-mediated tissue damage without broadly immunosuppressing.

Routes of Administration

Goals & Uses

• Acceleration of mucosal healingTissue RepairModerate
• Preservation of anti-tumor and antimicrobial immunityImmune ModulationLow
• Improvement in quality of life during cancer treatmentSupportive Oncology CareModerate
• Reduction of oral mucositis severityAnti Inflammatory / Mucosal ProtectionModerate

Contraindications

• Known hypersensitivity to dusquetide or any component of the formulationAllergy/hypersensitivityHigh

Adverse Effects

• Injection site reactionsLocalUncommon
• HeadacheNeurologicUncommonPain in the head or upper neck
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
• FatigueGeneralCommonLow energy or tiredness

Drug Interactions

• Cytotoxic chemotherapy agents (e.g., cisplatin, carboplatin)Low
• ImmunosuppressantsModeratePotential interaction with immune pathways or infection risk

Population Constraints

• Severe renal or hepatic impairmentOrgan FunctionRelative
• Pediatric patientsAgeRelative
• Pregnant or lactating womenReproductiveRelative

Regulatory Status

• European UnionInvestigationalNo EMA approval; investigational use only in the context of clinical trials.
• United StatesInvestigationalFDA Fast Track designation granted for oral mucositis in head and neck cancer. Phase 2 completed with encouraging results. Phase 3 development ongoing as of last available data.

Dusquetide received Fast Track designation from the U.S. FDA for treatment of oral mucositis associated with chemoradiation in head and neck cancer. It has completed Phase 2 clinical trials (SGX942-002) with positive signals. Phase 3 development has been pursued. No approved product as of available knowledge.

Evidence & Sources

No sources recorded yet.