Astodrimer clinical trials
Also written VivaGel.
How each study uses astodrimer is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
9 studies that test it; most in 2012 (2)
| Year | Studies |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2014 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 9 · Other 0
Starpharma Pty Ltd (9)
Studies
Open first, then newest update. How each study uses astodrimer is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 9
- Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)CompletedPhase 3Starpharma Pty LtdNCT02237950Written as 1% SPL7013 Gel
- A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial VaginosisCompletedPhase 3Starpharma Pty LtdNCT01577238Written as 1% SPL7013 Gel
- A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial VaginosisCompletedPhase 3Starpharma Pty LtdNCT01577537Written as 1% SPL7013 Gel
- Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)CompletedPhase 2Starpharma Pty LtdNCT01201057Written as 0.5% SPL7013 Gel
- Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.CompletedPhase 1/2Starpharma Pty LtdNCT00740584Written as 3% SPL7013 Gel (VivaGel)
- Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)CompletedPhase 3Starpharma Pty LtdNCT02236156Written as 1% SPL7013 Gel
- Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)CompletedPhase 2Starpharma Pty LtdNCT01437722Written as 1% SPL7013 Gel
- Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active WomenCompletedPhase 1Starpharma Pty LtdNCT00442910Written as 3% SPL7013 Gel (VivaGel)
- SPL7013 Gel - Male Tolerance StudyCompletedPhase 1Starpharma Pty LtdNCT00370357Written as 3% w/w SPL7013 Gel (VivaGel™)
Codes
What other systems call astodrimer · ClinicalTrials.gg INT004598
- MeSH (NLM) C480351astodrimerOne source NLM
- UNII (FDA) F8H3J9KSY9ASTODRIMERConfirmed FDA, NLM, Wikidata
- Wikidata Q106715120astodrimerConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C169789AstodrimerOne source FDA
- DrugBank DB11854One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C480351 | astodrimer | One source NLM |
| UNII (FDA) | F8H3J9KSY9 | ASTODRIMER | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q106715120 | astodrimer | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C169789 | Astodrimer | One source FDA |
| DrugBank | DB11854 | — | One source Wikidata |
Also registered as astodrimer sodium (UNII 8Q3B8SV59L).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.