Astodrimer
Also known as: Astodrimer sodium, BV Gel, SPL7013, VivaGel
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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
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.
Frequently Asked Questions
What is Astodrimer?
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.
What is Astodrimer used for?
Astodrimer is educationally associated with: HPV prevention, HIV prevention (topical microbicide), HSV prevention, COVID-19 prevention (nasal spray), Bacterial vaginosis treatment. Educational only — not medical advice.
How is Astodrimer administered?
Recorded routes of administration: Nasal, Topical, Vaginal.
What are the potential side effects of Astodrimer?
Reported adverse effects include: Headache, Vaginal irritation/burning, Vulvovaginal candidiasis, Vaginal discharge, Nasal irritation (nasal spray). This list is not exhaustive — consult a qualified clinician.
Who should avoid Astodrimer?
Recorded contraindications: Pregnancy (vaginal use), Known hypersensitivity to astodrimer or formulation excipients. Consult a qualified clinician before use.