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RBX2660
RBX2660 is a microbiota restoration therapy that repopulates the gut microbiome to treat recurrent Clostridioides difficile infection.
RBX2660 is a microbiota restoration therapy that repopulates the gut microbiome to treat recurrent Clostridioides difficile infection. Used for Recurrent Clostridioides difficile infection (rCDI).
At a glance
| Generic name | RBX2660 |
|---|---|
| Also known as | microbiota suspension, REBYOTA®, Microbiota suspension |
| Sponsor | Rebiotix Inc. |
| Drug class | Live biotherapeutic product |
| Modality | Biologic |
| Therapeutic area | Infectious Disease / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
RBX2660 is a rationally-designed, live biotherapeutic product containing a consortium of bacterial spores and vegetative cells derived from healthy donor stool. It restores a diverse and balanced gut microbiota, which competitively inhibits C. difficile colonization and toxin production. By reconstituting the protective microbial ecosystem, it addresses the underlying dysbiosis that predisposes patients to recurrent CDI.
Approved indications
- Recurrent Clostridioides difficile infection (rCDI)
Common side effects
- Abdominal pain
- Diarrhea
- Nausea
- Fever
Key clinical trials
- A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection (PHASE3)
- Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (PHASE3)
- Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3) (PHASE3)
- PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (PHASE1)
- Fecal Transplant for Hepatic Encephalopathy (PHASE1, PHASE2)
- Fecal Microbiota Transplantation (FMT) for MDRO UTI (PHASE1, PHASE2)
- Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PHASE2)
- Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (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:
- RBX2660 CI brief — competitive landscape report
- RBX2660 updates RSS · CI watch RSS
- Rebiotix Inc. portfolio CI