Golotimod

Summary

Golotimod (SCV-07) is a synthetic dipeptide immunomodulator derived from gamma-D-glutamyl-L-tryptophan. It has been investigated for treatment of tuberculosis, hepatitis C, and other infectious diseases as an immune adjunct therapy. It aims to restore or enhance cell-mediated immunity, particularly in immunocompromised patients.

Mechanism of Action

Toll-like receptor 9 (TLR9) agonist and immunomodulator; stimulates T-cell maturation and differentiation, enhances innate and adaptive immune responses by activating dendritic cells and promoting Th1-type cytokine production

Routes of Administration

Goals & Uses

• Adjunct treatment of tuberculosisInfectious DiseaseModerate
• Oral mucositis preventionOncology Supportive CareLow
• Immune restoration in immunocompromised patientsImmunologyLow
• Hepatitis C treatment supportInfectious DiseaseLow

Contraindications

• Autoimmune conditions (active)AutoimmuneModerate
• Known hypersensitivity to golotimod or componentsAllergyHigh

Adverse Effects

• Injection site reactionsLocalCommon
• Gastrointestinal discomfortGastrointestinalUncommon
• FatigueGeneralUncommonLow energy or tiredness
• FeverSystemicUncommonElevated body temperature

Drug Interactions

• Immunosuppressants (e.g., corticosteroids, cyclosporine)Moderate
• Antitubercular agents (e.g., rifampicin, isoniazid)Low

Population Constraints

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

Regulatory Status

• European UnionInvestigationalNo EMA approval; clinical trials conducted in Eastern Europe and Russia
• United StatesInvestigationalInvestigated under IND; not FDA approved for any indication
• United KingdomUnknownNo known MHRA approval; status not clearly defined

Not approved by FDA, EMA, or other major regulatory agencies. Studied under investigational new drug (IND) status in clinical trials. Developed by SciClone Pharmaceuticals and related entities.

Evidence & Sources

No sources recorded yet.