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EcN-Suspension
EcN-Suspension is a Live biotherapeutic product Small molecule drug developed by Ardeypharm GmbH. It is currently in Phase 3 development for Inflammatory bowel disease (IBD) or related gastrointestinal inflammatory conditions. Also known as: E. coli strain Nissle 1917 bacteria.
EcN-Suspension is a live biotherapeutic containing engineered Escherichia coli Nissle 1917 designed to modulate the gut microbiome and immune system.
EcN-Suspension is a live biotherapeutic containing engineered Escherichia coli Nissle 1917 designed to modulate the gut microbiome and immune system. Used for Inflammatory bowel disease (IBD) or related gastrointestinal inflammatory conditions.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | EcN-Suspension |
|---|---|
| Also known as | E. coli strain Nissle 1917 bacteria |
| Sponsor | Ardeypharm GmbH |
| Drug class | Live biotherapeutic product |
| Modality | Small molecule |
| Therapeutic area | Immunology / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
The drug consists of a non-pathogenic, genetically modified strain of E. coli that colonizes the intestinal tract and produces therapeutic metabolites or antigens. By restoring beneficial bacterial populations and promoting local and systemic immune tolerance, it aims to treat inflammatory and immune-mediated conditions. The suspension formulation allows oral delivery of viable bacterial cells to the gastrointestinal tract.
Approved indications
- Inflammatory bowel disease (IBD) or related gastrointestinal inflammatory conditions
Common side effects
- Gastrointestinal disturbances
- Abdominal discomfort
- Diarrhea
Key clinical trials
- Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome (EARLY_PHASE1)
- E. Coli Nissle 1917 - Suspension for Infection Prophylaxis (PHASE3)
- E. Coli Nissle in Oncology (PHASE3)
- Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
- Prophylaxis of Gastrointestinal Infections With EcN (PHASE4)
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:
- EcN-Suspension CI brief — competitive landscape report
- EcN-Suspension updates RSS · CI watch RSS
- Ardeypharm GmbH portfolio CI
Frequently asked questions about EcN-Suspension
What is EcN-Suspension?
How does EcN-Suspension work?
What is EcN-Suspension used for?
Who makes EcN-Suspension?
Is EcN-Suspension also known as anything else?
What drug class is EcN-Suspension in?
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Related
- Drug class: All Live biotherapeutic product drugs
- Manufacturer: Ardeypharm GmbH — full pipeline
- Therapeutic area: All drugs in Immunology / Gastroenterology
- Indication: Drugs for Inflammatory bowel disease (IBD) or related gastrointestinal inflammatory conditions
- Also known as: E. coli strain Nissle 1917 bacteria
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing