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S salivarius
S salivarius is a Small molecule drug developed by Universidade de Passo Fundo. It is currently in Phase 2 development. Also known as: Streptococcus salivarius.
S salivarius is a probiotic strain studied for its potential benefits in conditions such as gingivitis, halitosis, and nausea during pregnancy, among others. It is administered in the form of lozenges, such as SALI-10, which may contain additional ingredients like quercetin, and has been evaluated in clinical trials for its safety and efficacy.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | S salivarius |
|---|---|
| Also known as | Streptococcus salivarius |
| Sponsor | Universidade de Passo Fundo |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Bacteriophages in Addition to Antibiotics for the Treatment of Patients With Infective Endocarditis (PHASE3)
- Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (NA)
- Oral Probiotics for Halitosis in Healthy Adults (NA)
- Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis (PHASE2)
- Evaluation of Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius eK12 (NA)
- Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis (NA)
- Evaluation of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Periodontal Health and Salivary Parameters (NA)
- Determining the Viability a Lozenge Dosage for Probiotics (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- S salivarius CI brief — competitive landscape report
- S salivarius updates RSS · CI watch RSS
- Universidade de Passo Fundo portfolio CI
Frequently asked questions about S salivarius
What is S salivarius?
Who makes S salivarius?
Is S salivarius also known as anything else?
What development phase is S salivarius in?
Related
- Manufacturer: Universidade de Passo Fundo — full pipeline
- Also known as: Streptococcus salivarius
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing