Vowst FDA Approval History
Last updated by Judith Stewart, BPharm on May 2, 2023.
FDA Approved: Yes (First approved April 26, 2023)
Brand name: Vowst
Generic name: fecal microbiota spores, live-brpk
Dosage form: Capsules
Previous Name: SER-109
Company: Seres Therapeutics, Inc.
Treatment for: Prevention of Recurrent Clostridioides difficile Infection
Vowst (fecal microbiota spores, live-brpk) is an oral microbiome therapeutic indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.
- Clostridioides difficile infection is a potentially life-threatening bacterial infection resulting in diarrhea and significant inflammation of the colon. It is caused by a change to the balance of microorganisms in the gut (such as after taking antibiotics to treat an infection) that allows C. difficile to multiply and release harmful toxins. After recovery from CDI, individuals may get the infection again multiple times, a condition known as recurrent CDI.
- Vowst is an oral microbiome therapeutic consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome. Vowst contains live bacteria and is manufactured from human fecal matter sourced from qualified donors.
- Vowst is thought to work to reduce the recurrence of CDI by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth.
- Vowst capsules are taken orally once daily on an empty stomach for 3 consecutive days. Antibacterial treatment for recurrent CDI should be completed 2 to 4 days before initiating treatment with Vowst.
- Warnings and precautions associated with Vowst include a risk of transmitting infectious agents and the potential to cause food allergies.
- Common adverse reactions include abdominal distension, fatigue, constipation, chills, and diarrhea.
Development timeline for Vowst
Further information
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