Hiltonol
Also known as: Hiltonol, NSC-301463, Poly I:C/LC, Poly-ICLC, PolyICLC
Source Hiltonol at Peptiology
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Summary
Hiltonol (poly-ICLC) is a synthetic double-stranded RNA adjuvant and immunostimulant developed by Oncovir. It is under investigation primarily as a vaccine adjuvant in cancer immunotherapy (e.g., glioblastoma, melanoma) and infectious disease vaccines. It has been explored in HIV, West Nile virus, and SARS-CoV-2 vaccine platforms. It is not currently FDA-approved for any indication but has been used in numerous clinical trials.
Mechanism of Action
Hiltonol is a stabilized formulation of polyinosinic-polycytidylic acid complexed with poly-L-lysine and carboxymethylcellulose (poly-ICLC). It activates Toll-like receptor 3 (TLR3) and cytosolic RNA helicases (MDA5/RIG-I), stimulating innate immune signaling, type I interferon production, and dendritic cell maturation, thereby enhancing both cellular and humoral adaptive immune responses.
Routes of Administration
Goals & Uses
- Antitumor activityOncologyLow
- Neuroprotection/neuroimmune modulationNeurologyLow
- Innate immune activationImmunostimulationHigh
- Infectious disease vaccine adjuvantVaccinologyModerate
- Cancer vaccine adjuvantImmunotherapyModerate
Contraindications
- Known hypersensitivity to poly-ICLC componentsAllergicHigh
- Active severe systemic infectionInfectiousModerate
- Severe autoimmune diseaseImmunologicalHigh
Adverse Effects
- Flu-like symptomsSystemic/ImmunologicalCommon
- Cytokine release syndromeImmunologicRareSystemic inflammatory response from immune activation
- Injection site reactionsLocalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- FatigueGeneralCommonLow energy or tiredness
- Elevated liver enzymes (transaminases)HepaticUncommon
Drug Interactions
- Anticoagulants (e.g., warfarin)Low
- Immunosuppressants (e.g., corticosteroids, cyclosporine)Moderate
- Other TLR agonists / immunostimulantsModerate
Population Constraints
- Pediatric patientsAgeRelative
- Elderly patients (>75 years)AgeRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Patients with severe hepatic impairmentHepaticRelative
Regulatory Status
- European UnionInvestigationalNo EMA approval; available only in clinical trial settings.
- United StatesInvestigationalUsed exclusively under IND applications; not FDA-approved. Orphan Drug Designation obtained for certain indications.
- United KingdomInvestigationalNo MHRA approval; investigational use only.
Not FDA-approved; used under IND applications in clinical trials. Designated as an investigational product by Oncovir, Inc. Has received Orphan Drug Designation for certain oncology indications. Available to qualified researchers under IND.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Hiltonol?
Hiltonol (poly-ICLC) is a synthetic double-stranded RNA adjuvant and immunostimulant developed by Oncovir. It is under investigation primarily as a vaccine adjuvant in cancer immunotherapy (e.g., glioblastoma, melanoma) and infectious disease vaccines. It has been explored in HIV, West Nile virus, and SARS-CoV-2 vaccine platforms. It is not currently FDA-approved for any indication but has been used in numerous clinical trials.
What is Hiltonol used for?
Hiltonol is educationally associated with: Antitumor activity, Neuroprotection/neuroimmune modulation, Innate immune activation, Infectious disease vaccine adjuvant, Cancer vaccine adjuvant. Educational only — not medical advice.
How is Hiltonol administered?
Recorded routes of administration: Intramuscular, Intranasal, Intratumoral, Subcutaneous.
What are the potential side effects of Hiltonol?
Reported adverse effects include: Flu-like symptoms, Cytokine release syndrome, Injection site reactions, Headache, Fatigue, Elevated liver enzymes (transaminases). This list is not exhaustive — consult a qualified clinician.
Who should avoid Hiltonol?
Recorded contraindications: Known hypersensitivity to poly-ICLC components, Active severe systemic infection, Severe autoimmune disease. Consult a qualified clinician before use.