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Bifidobacteria
Bifidobacteria is a Small molecule drug developed by University of Campania Luigi Vanvitelli. It is currently in Phase 3 development. Also known as: longum infantis M16V.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Bifidobacteria |
|---|---|
| Also known as | longum infantis M16V |
| Sponsor | University of Campania Luigi Vanvitelli |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete (NA)
- Probiotics for Women (NA)
- Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees) (NA)
- A Probiotic Intervention to Prevent Relapse Following Hospitalization for Mania (PHASE3)
- The Bloom Infant Probiotic (BIP) Study (PHASE2)
- Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS (NA)
- The Effect of Galactooligosaccharides (GOS) on the Gut Microbiota of Lactose Intolerance Individuals (NA)
- Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin® (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:
- Bifidobacteria CI brief — competitive landscape report
- Bifidobacteria updates RSS · CI watch RSS
- University of Campania Luigi Vanvitelli portfolio CI
Frequently asked questions about Bifidobacteria
What is Bifidobacteria?
Who makes Bifidobacteria?
Is Bifidobacteria also known as anything else?
What development phase is Bifidobacteria in?
Related
- Manufacturer: University of Campania Luigi Vanvitelli — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Also known as: longum infantis M16V
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing