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Fecal Microbial Transplantation
Fecal Microbial Transplantation is a Biotherapeutic microbiota therapeutic Biologic drug developed by ProgenaBiome. It is currently in Phase 3 development for Clostridioides difficile infection (recurrent or refractory), Inflammatory bowel disease (Crohn's disease, ulcerative colitis). Also known as: FMT, Fecal Transplant, Stool transplant.
Fecal microbial transplantation (FMT) restores a healthy gut microbiome by transferring bacterial communities from a healthy donor to a patient with dysbiosis.
Fecal Microbial Transplantation (FMT) is being studied as a potential treatment for various conditions, including steroid-refractory Graft-versus-host Disease, according to a clinical trial (NCT07602751) conducted by Bambino Gesù Hospital and Research Institute. The conditions studied in this trial include Acute Graft Versus Host Disease in Intestine, among others, and FMT is being compared to a placebo.
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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 | Fecal Microbial Transplantation |
|---|---|
| Also known as | FMT, Fecal Transplant, Stool transplant |
| Sponsor | ProgenaBiome |
| Drug class | Biotherapeutic microbiota therapeutic |
| Modality | Biologic |
| Therapeutic area | Gastroenterology / Infectious Disease / Immunology |
| Phase | Phase 3 |
Mechanism of action
FMT works by introducing diverse microbial populations from screened healthy donors into the patient's gastrointestinal tract, thereby restoring microbial diversity and function. This rebalancing of the microbiome can reduce pathogenic bacteria, restore beneficial metabolic functions, and modulate immune responses. The restored microbiota helps re-establish colonization resistance and normal gut barrier function.
Approved indications
- Clostridioides difficile infection (recurrent or refractory)
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Common side effects
- Gastrointestinal symptoms (abdominal pain, bloating, diarrhea)
- Fever
- Nausea
- Infection or bacteremia (rare)
Key clinical trials
- Fecal Microbial Transplants for the Treatment of Pancreatic Cancer (EARLY_PHASE1)
- Neurocognitive Effects of FMT in MDD Patients With and Without IBS (PHASE2, PHASE3)
- Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes (NA)
- Feasibility Study of MET-4: Evaluating Fecal Microbiome Effects in Immunotherapy Patients (PHASE2, PHASE3)
- Clostridioides Difficile: Understanding Responses and Treatment Effects
- Aging Resilience Through Microbiota Optimization and Regulation (PHASE1)
- Fecal Microbiota Transplantation for the Treatment of ICU Delirium (NA)
- Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV) (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:
- Fecal Microbial Transplantation CI brief — competitive landscape report
- Fecal Microbial Transplantation updates RSS · CI watch RSS
- ProgenaBiome portfolio CI
Frequently asked questions about Fecal Microbial Transplantation
What is Fecal Microbial Transplantation?
How does Fecal Microbial Transplantation work?
What is Fecal Microbial Transplantation used for?
Who makes Fecal Microbial Transplantation?
Is Fecal Microbial Transplantation also known as anything else?
What drug class is Fecal Microbial Transplantation in?
What development phase is Fecal Microbial Transplantation in?
What are the side effects of Fecal Microbial Transplantation?
Related
- Drug class: All Biotherapeutic microbiota therapeutic drugs
- Manufacturer: ProgenaBiome — full pipeline
- Therapeutic area: All drugs in Gastroenterology / Infectious Disease / Immunology
- Indication: Drugs for Clostridioides difficile infection (recurrent or refractory)
- Indication: Drugs for Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Also known as: FMT, Fecal Transplant, Stool transplant
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing