DelveInsight’s, “Clostridium Difficile Infections Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Clostridium Difficile Infections pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Clostridium Difficile Infections Pipeline Report

• In June 2025, Vedanta Biosciences Inc. announced a study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
• In June 2025, Crestone Inc. announced a research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.
• DelveInsight’s Clostridium Difficile Infections pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for Clostridium Difficile Infections treatment.
• The leading Clostridium Difficile Infections Companies such as Acurx Pharmaceuticals, Adiso Therapeutics, Summit Therapeutics, Finch Therapeutics Group, Mikrobiomik Healthcare Company S.L., Crestone, MGB Biopharma, Vedanta Biosciences, Deinove, Biovertis AG, Lumen Bioscience, ImmuniMed, Deinove and others.
• Promising Clostridium Difficile Infections Pipeline Therapies such as VE303, Ibezapolstat, Vancomycin, SER-109, RBX2660, MK-6072, MK-3415A, Fidaxomicin and others.

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Clostridium Difficile Infections Emerging Drugs Profile

• VE303: Vedanta Biosciences

VE303 is a potential first-in-class live biotherapeutic product candidate being developed by Vedanta Biosciences to prevent recurrence of Clostridioides difficile infection (CDI). It consists of a rationally-designed, defined bacterial consortium of 8 strains of clonal human commensal bacteria selected for their ability to provide colonization resistance to C. difficile. VE303 is administered orally in capsules and is produced under CGMP conditions from pure, clonal bacterial cell banks, yielding a standardized drug product. In a Phase II study, high-dose VE303 met its primary endpoint of preventing CDI recurrence at eight weeks in patients at high risk of recurrence. VE303 was generally well-tolerated in the study. Vedanta is currently enrolling patients into a pivotal Phase III registrational study called RESTORATiVE303 to evaluate the efficacy and safety of VE303 for the prevention of recurrent CD.

• Ibezapolstat: Acurx Pharmaceuticals

Ibezapolstat (formerly named ACX-362E) is our lead antibiotic candidate. Ibezapolstat is a first-in-class of a new class of Pol IIIC inhibitors which is in clinical development to treat C. difficile infections or CDI. In June 2018, ibezapolstat was designated by the US Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted Fast Track designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. Currently, the drug is in the Phase II stage of its development for the treatment of Clostridium Difficile Infections.

The Clostridium Difficile Infections Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Clostridium Difficile Infections with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Clostridium Difficile Infections Treatment.
• Clostridium Difficile Infections Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Clostridium Difficile Infections Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Clostridium Difficile Infections market

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Clostridium Difficile Infections Companies

Acurx Pharmaceuticals, Adiso Therapeutics, Summit Therapeutics, Finch Therapeutics Group, Mikrobiomik Healthcare Company S.L., Crestone, MGB Biopharma, Vedanta Biosciences, Deinove, Biovertis AG, Lumen Bioscience, ImmuniMed, Deinove and others.

Clostridium Difficile Infections pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Clostridium Difficile Infections Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Scope of the Clostridium Difficile Infections Pipeline Report

• Coverage- Global
• Clostridium Difficile Infections Companies- Acurx Pharmaceuticals, Adiso Therapeutics, Summit Therapeutics, Finch Therapeutics Group, Mikrobiomik Healthcare Company S.L., Crestone, MGB Biopharma, Vedanta Biosciences, Deinove, Biovertis AG, Lumen Bioscience, ImmuniMed, Deinove and others.
• Clostridium Difficile Infections Pipeline Therapies such as VE303, Ibezapolstat, Vancomycin, SER-109, RBX2660, MK-6072, MK-3415A, Fidaxomicin and others.
• Clostridium Difficile Infections Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Clostridium Difficile Infections Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

1. Introduction
2. Executive Summary
3. Clostridium Difficile Infections: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Clostridium Difficile Infections– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. VE303: Vedanta Biosciences
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. Ibezapolstat: Acurx Pharmaceuticals
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. Drug name: Company name
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Clostridium Difficile Infections Key Companies
21. Clostridium Difficile Infections Key Products
22. Clostridium Difficile Infections- Unmet Needs
23. Clostridium Difficile Infections- Market Drivers and Barriers
24. Clostridium Difficile Infections- Future Perspectives and Conclusion
25. Clostridium Difficile Infections Analyst Views
26. Clostridium Difficile Infections Key Companies
27. Appendix

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