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e.-coli-nissle
e.-coli-nissle is a Probiotic Small molecule drug developed by GWT-TUD GmbH. It is currently in Phase 3 development for Ulcerative colitis, Irritable bowel syndrome. Also known as: Mutaflor.
E. coli Nissle is a probiotic bacterium that modulates the gut microbiome to exert its therapeutic effects.
E. coli Nissle 1917, also known as Mutaflor Suspension, has been studied for its potential to treat various conditions, including Escherichia Coli Infections, Diabetes, Urinary Tract Infections in Children, Secondary Prevention, and Irritable Bowel Syndrome. The exact mechanism of E. coli Nissle 1917 is not specified in the provided information, but it has been used in clinical trials involving blood and stool samples.
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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).
| 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 | e.-coli-nissle |
|---|---|
| Also known as | Mutaflor |
| Sponsor | GWT-TUD GmbH |
| Drug class | Probiotic |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
E. coli Nissle is a commensal bacterium that colonizes the gut and produces metabolites that influence the host's immune system and overall health. By modulating the gut microbiome, E. coli Nissle can help to prevent and treat various diseases.
Approved indications
- Ulcerative colitis
- Irritable bowel syndrome
Common side effects
- Abdominal pain
- Diarrhea
- Flatulence
Key clinical trials
- Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers (PHASE1)
- Probiotic After Acute Colonic Diverticulitis
- Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome (EARLY_PHASE1)
- Preventing Urinary Tract Infections With E. Coli Nissle: (PHASE4)
- Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment. (PHASE4)
- Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy (NA)
- E. Coli Nissle 1917 - Suspension for Infection Prophylaxis (PHASE3)
- Effects of Nutritional Fat on the Growth of Intestinal E. Coli (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:
- e.-coli-nissle CI brief — competitive landscape report
- e.-coli-nissle updates RSS · CI watch RSS
- GWT-TUD GmbH portfolio CI
Frequently asked questions about e.-coli-nissle
What is e.-coli-nissle?
How does e.-coli-nissle work?
What is e.-coli-nissle used for?
Who makes e.-coli-nissle?
Is e.-coli-nissle also known as anything else?
What drug class is e.-coli-nissle in?
What development phase is e.-coli-nissle in?
What are the side effects of e.-coli-nissle?
Related
- Drug class: All Probiotic drugs
- Manufacturer: GWT-TUD GmbH — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Ulcerative colitis
- Indication: Drugs for Irritable bowel syndrome
- Also known as: Mutaflor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing