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Fecal Microbiota Enema
Fecal Microbiota Enema is a Biologic drug developed by McMaster Children's Hospital. It is currently in Phase 1 development. Also known as: FMT, RBX2660, Rebiotix, Fecal microbial enema.
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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 | Fecal Microbiota Enema |
|---|---|
| Also known as | FMT, RBX2660, Rebiotix, Fecal microbial enema |
| Sponsor | McMaster Children's Hospital |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Diarrhoea
- Abdominal pain
- Nausea
- Abdominal distension
- Urinary tract infection
- Flatulence
- Constipation
Key clinical trials
- Transfer of Feces in Ulcerative Colitis 2 (PHASE2)
- Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT) (PHASE2)
- PMT for MDRO Decolonization (PHASE2)
- Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
- Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma (PHASE2)
- STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection (NA)
- Fecal Microbiota Transplant for Patients With Chronic Pouchitis (EARLY_PHASE1)
- FMT in Cirrhosis and Hepatic Encephalopathy (PHASE1, PHASE2)
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:
- Fecal Microbiota Enema CI brief — competitive landscape report
- Fecal Microbiota Enema updates RSS · CI watch RSS
- McMaster Children's Hospital portfolio CI
Frequently asked questions about Fecal Microbiota Enema
What is Fecal Microbiota Enema?
Who makes Fecal Microbiota Enema?
Is Fecal Microbiota Enema also known as anything else?
What development phase is Fecal Microbiota Enema in?
What are the side effects of Fecal Microbiota Enema?
Related
- Manufacturer: McMaster Children's Hospital — full pipeline
- Also known as: FMT, RBX2660, Rebiotix, Fecal microbial enema
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing