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SER-109
SER-109 is a spore-based microbiome therapeutic that restores healthy gut bacterial composition to prevent recurrent Clostridioides difficile infection.
SER-109 is a spore-based microbiome therapeutic that restores healthy gut bacterial composition to prevent recurrent Clostridioides difficile infection. Used for Recurrent Clostridioides difficile infection (rCDI) in adults.
At a glance
| Generic name | SER-109 |
|---|---|
| Also known as | Purified Eubacterial Spores, Encapsulated, Firmicutes spores, Eubacterial Spores, Purified Suspension, Encapsulated |
| Sponsor | Seres Therapeutics, Inc. |
| Drug class | Microbiome therapeutic |
| Modality | Biologic |
| Therapeutic area | Infectious Disease / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
SER-109 contains purified spores from a consortium of commensal Bacillus species that colonize the gut and restore microbial diversity. By re-establishing a healthy microbiome, it reduces the risk of C. difficile recurrence by outcompeting pathogenic strains and restoring colonization resistance. This approach addresses the underlying dysbiosis that predisposes patients to recurrent CDI.
Approved indications
- Recurrent Clostridioides difficile infection (rCDI) in adults
Common side effects
- Abdominal pain
- Diarrhea
- Nausea
- Vomiting
Key clinical trials
- Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)
- ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (PHASE3)
- ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection (PHASE3)
- SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) (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:
- SER-109 CI brief — competitive landscape report
- SER-109 updates RSS · CI watch RSS
- Seres Therapeutics, Inc. portfolio CI