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Visbiome
Visbiome is a Small molecule drug developed by University Health Network, Toronto. It is currently in Phase 2 development.
Visbiome is a probiotic being studied in clinical trials for various conditions, including Gulf War Illness, Colorectal Cancer, Cognition, Gut Microbiome, and HIV-1 Infection. It is being compared to a placebo in these trials, with some studies also comparing it to VSL#3, another probiotic.
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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 | Visbiome |
|---|---|
| Sponsor | University Health Network, Toronto |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The GLUCID Study: Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers (NA)
- Probiotics in Newly Diagnosed T1D (PHASE2)
- The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study (NA)
- Probiotic Administration for Adolescent Depression (EARLY_PHASE1)
- Intervention on New Onset-T1D Children (NA)
- Effects of a Multi-strain Oral Probiotic on the Vaginal Microbiota Composition in Healthy Women and Women with Endometriosis (NA)
- Prebiotic vs Probiotic in Multiple Sclerosis (NA)
- Visbiome Effect on Colorectal Anastomosis and Local Recurrence (NA)
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:
- Visbiome CI brief — competitive landscape report
- Visbiome updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI
Frequently asked questions about Visbiome
What is Visbiome?
Who makes Visbiome?
What development phase is Visbiome in?
Related
- Manufacturer: University Health Network, Toronto — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing