FDA Approves VOWST: First-Ever Oral Microbiome Therapeutic from Seres Therapeutics

The FDA approved VOWST (formerly SER-109), making it the first-ever FDA-approved oral microbiome therapeutic. Developed by Seres Therapeutics in partnership with Nestle Health Science, VOWST prevents recurrence of Clostridioides difficile infection (CDI) in adults who have completed antibacterial treatment.

The Phase 3 ECOSPOR III clinical trial demonstrated that approximately 88% of VOWST-treated patients were recurrence-free at 8 weeks, compared to 60% for placebo. At six months, 79% of the VOWST group remained recurrence-free versus 53% in the placebo group. The drug received Breakthrough Therapy designation and Priority Review.

Seres Therapeutics went public in 2015, raising $133.8 million at its IPO. VOWST was later sold to Nestle in September 2024 for up to $450 million in total potential payments.