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H10407 challenge strain
H10407 challenge strain is a Biologic drug developed by PATH. It is currently in Phase 1 development. Also known as: ST+, LT+, CFA/I toxin.
The H10407 challenge strain is used in a low-dose challenge model to study diarrhea. This strain induces an immune response, according to its mechanism as a biological vaccine.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | H10407 challenge strain |
|---|---|
| Also known as | ST+, LT+, CFA/I toxin |
| Sponsor | PATH |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults (PHASE1, PHASE2)
- Low-dose Challenge Model With Enterotoxigenic E Coli (PHASE1)
- Safety and Efficacy Study of a Vaccine Against Enterotoxigenic Escherichia Coli (ETEC) to Prevent Moderate to Severe Diarrhea (PHASE2)
- Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I (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:
- H10407 challenge strain CI brief — competitive landscape report
- H10407 challenge strain updates RSS · CI watch RSS
- PATH portfolio CI
Frequently asked questions about H10407 challenge strain
What is H10407 challenge strain?
Who makes H10407 challenge strain?
Is H10407 challenge strain also known as anything else?
What development phase is H10407 challenge strain in?
Related
- Manufacturer: PATH — full pipeline
- Also known as: ST+, LT+, CFA/I toxin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing