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Synbiotic
Synbiotic is a Small molecule drug developed by The University of Texas Health Science Center at San Antonio. It is currently in Phase 2 development.
Synbiotic is a type of dietary supplement that combines probiotics and prebiotics to promote synergistic effects on gut health. A study on Synbiotic Health's ED02 probiotic supplement, which combines Bifidobacterium pseudocatenulatum and Lactobacillus paracasei paracasei strain F19, aimed to evaluate its safety, tolerability, and impact on gastrointestinal outcomes in a randomized, double-blind, placebo-controlled pilot study.
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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 | Synbiotic |
|---|---|
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Synbiotic to Attenuate Resorption of the Skeleton (NA)
- Synbiotic Supplement With Botanical Extracts for Gut Microbiota Balance in Irritable Bowel Syndrome (NA)
- Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis (EARLY_PHASE1)
- A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health (NA)
- Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer (NA)
- Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients (NA)
- Exploratory Study on a Multi-nutrient Supplement and Exercise Program for Improving Health Markers Associated to Longevity in Pre-frail Adults (NA)
- The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight (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:
- Synbiotic CI brief — competitive landscape report
- Synbiotic updates RSS · CI watch RSS
- The University of Texas Health Science Center at San Antonio portfolio CI
Frequently asked questions about Synbiotic
What is Synbiotic?
Who makes Synbiotic?
What development phase is Synbiotic in?
Related
- Manufacturer: The University of Texas Health Science Center at San Antonio — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing