Astodrimer

Dendrimer (polyanionic Carbosilane Dendrimer / SPL7013 Dendrimer)Rx: PrescriptionCompound: Approved

Also known as: Astodrimer sodium, BV Gel, SPL7013, VivaGel

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Astodrimer (SPL7013) is a polyanionic dendrimer developed as a topical microbicide and antiviral agent. It is approved in Australia as a vaginal gel (VivaGel) for bacterial vaginosis. It has also been investigated for prevention of HIV, HSV, and other sexually transmitted infections, as well as for COVID-19 nasal spray formulations.

Mechanism of Action

Astodrimer is a lysine-based dendrimer with naphthalene disulfonic acid surface groups that electrostatically and sterically block attachment of pathogens (including HIV, HSV, HPV, and SARS-CoV-2) to host cell receptors, preventing viral entry. It acts as a broad-spectrum topical microbicide by physically coating mucosal surfaces.

Routes of Administration

NasalTopicalVaginal

Goals & Uses

  • HPV preventionAnti Infective / PreventionLow
  • HIV prevention (topical microbicide)Anti Infective / PreventionModerate
  • HSV preventionAnti Infective / PreventionModerate
  • COVID-19 prevention (nasal spray)Anti Infective / PreventionModerate
  • Bacterial vaginosis treatmentAnti Infective / GynaecologyHigh

Contraindications

  • Pregnancy (vaginal use)ReproductiveModerate
  • Known hypersensitivity to astodrimer or formulation excipientsAllergyHigh

Adverse Effects

  • HeadacheNeurologicUncommonPain in the head or upper neck
  • Vaginal irritation/burningLocalCommon
  • Vulvovaginal candidiasisGynaecologicalUncommon
  • Vaginal dischargeLocalCommon
  • Nasal irritation (nasal spray)LocalCommon

Drug Interactions

  • Intravaginal medicationsLow
  • Latex condoms/diaphragmsModerate

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Pediatric patientsAgeAbsolute
  • Immunocompromised individualsImmunologicalRelative

Regulatory Status

  • AUApprovedApproved: Bacterial vaginosis (VivaGel vaginal gel 1%)Approved by the TGA (Therapeutic Goods Administration) in Australia.
  • European UnionApprovedApproved: Bacterial vaginosis (VivaGel vaginal gel 1%)Approved by EMA in Europe for bacterial vaginosis.
  • United StatesInvestigationalNot FDA-approved; investigational for BV and STI prevention; VivaGel BV not yet approved in the US.

Approved in Australia by the TGA as VivaGel (astodrimer sodium 1% vaginal gel) for bacterial vaginosis. Also approved in Europe (EMA) for the same indication. Investigational for HIV/STI prevention and COVID-19 nasal spray in various jurisdictions.

Evidence & Sources

No sources recorded yet.

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