Oglufanide

Summary

Oglufanide (SCV-07, gamma-D-glutamyl-L-tryptophan) is a synthetic immunomodulatory dipeptide investigated primarily for its ability to restore immune function in chronic viral infections, particularly hepatitis C, and for oral mucositis associated with radiation therapy. It has shown activity in stimulating T-cell responses and has been studied in Russian clinical contexts as well as Western investigational trials.

Mechanism of Action

Synthetic dipeptide (gamma-D-glutamyl-L-tryptophan) that modulates immune function by activating T-lymphocytes and natural killer cells, enhancing cytokine production (including IL-2 and interferon-gamma), and restoring immune homeostasis in immunocompromised states.

Routes of Administration

Goals & Uses

• Immunorestoration in immunodeficiencyImmunologyLow
• Hepatitis C immune modulationInfectious DiseaseModerate
• Tuberculosis adjunct therapyInfectious DiseaseLow
• Treatment of oral mucositis from radiationOncology Supportive CareModerate

Contraindications

• Organ transplant recipients on immunosuppressionTransplantModerate
• Active autoimmune diseaseAutoimmunityModerate
• Known hypersensitivity to oglufanide or its componentsAllergyHigh

Adverse Effects

• Injection site reactionsLocalCommon
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
• FatigueGeneralUncommonLow energy or tiredness
• Fever/flu-like symptomsSystemicUncommon

Drug Interactions

• Interferons (e.g., pegylated interferon-alpha)Low
• Immunosuppressants (e.g., corticosteroids, cyclosporine)Moderate

Population Constraints

• PregnancyReproductive SafetyRelative
• Severe hepatic or renal impairmentOrgan ImpairmentRelative
• Pediatric patientsAgeRelative

Regulatory Status

• European UnionUnknownNo EMA approval; limited regulatory history in EU.
• United StatesInvestigationalStudied under IND for oral mucositis and hepatitis C; no FDA approval.
• United KingdomUnknownNo MHRA approval documented.

Not approved by the FDA or EMA. Investigated under IND in the US for oral mucositis and hepatitis C. Has been used in some Eastern European countries under research or compassionate-use frameworks. No current approved indication in major Western regulatory jurisdictions.

Evidence & Sources

No sources recorded yet.