- In October 2024, Recursion announced that the first patient had been dosed in its Phase 2 clinical trial of REC-3964, a potential first-in-class oral small molecule and new chemical entity aimed at treating recurrent Clostridioides difficile infection. C. diff, a toxin-producing bacteria that causes diarrhea and ulcerative colitis, can be life-threatening. Recursion's study will focus initially on the recurrent C. diff. population, which sees up to 175,000 cases annually in the United States and incurs around two billion dollars in healthcare costs each year.
- In February 2024, Acurx Pharmaceuticals, Inc. announced that the FDA had granted an End-of-Phase 2 (EOP2) meeting to discuss the comprehensive Phase 3 clinical and non-clinical development plan for submitting a New Drug Application (NDA) for ibezapolstat, intended for the treatment of Clostridioides difficile infection (CDI). The completed Phase 2a portion of the trial involved an open-label cohort of up to 20 participants from U.S. study centers. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with 450 mg of ibezapolstat, taken orally twice daily for 10 days.
- In April 2023, the U.S. Food and Drug Administration approved Vowst, the first orally administered fecal microbiota product. Vowst is approved for the prevention of recurrent Clostridioides difficile (C. difficile) infection (CDI) in adults aged 18 and older, following antibiotic treatment for recurrent CDI. The prescribed dosing regimen for Vowst consists of four capsules taken orally once a day for three consecutive days.
- In February 2023, Ferring Pharmaceuticals announced that REBYOTA (fecal microbiota, live – jslm) is now available in the United States. REBYOTA is the first and only microbiome-based treatment approved by the U.S. Food and Drug Administration (FDA) for preventing the recurrence of Clostridioides difficile (C. diff) infection in adults aged 18 and older, following antibiotic treatment for recurrent C. diff infection. The FDA granted approval for REBYOTA on November 30, 2022.
- In January 2020, Merck announced that the U.S. Food and Drug Administration (FDA) had approved a New Drug Application (NDA) for DIFICID (fidaxomicin) oral suspension, as well as a supplemental New Drug Application (sNDA) for DIFICID tablets. These approvals are for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older. DIFICID is indicated only for infections that are confirmed or strongly suspected to be caused by Clostridioides difficile (C. difficile).
Frequently Asked Questions
Companies such as Astellas Pharma Inc. (Japan), Acurx Pharmaceuticals, Inc. (U.S.), ANI Pharmaceuticals Inc. (U.S.), Apotex Inc. (Canada) and AbbVie Inc. (U.S.) are the major companies in the Clostridium difficile infections market.
In February 2024, Acurx Pharmaceuticals, Inc. announced that the FDA had granted an End-of-Phase 2 (EOP2) meeting to discuss the comprehensive Phase 3 clinical and non-clinical development plan for submitting a New Drug Application (NDA) for ibezapolstat. In February 2023, Ferring Pharmaceuticals announced that REBYOTA (fecal microbiota, live – jslm) is now available in the United States.
The countries covered in the Clostridium difficile infections market are U.S., Canada and Mexico, Germany, France, U.K., Italy, Russia, Spain, Denmark, Sweden, Norway, Rest of Europe, China, Japan, India, South Korea, Australia, Thailand, Rest of Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Nigeria, Egypt, Kuwait, Rest of Middle East and Africa, Brazil, Argentina and Rest of South America.
