Clostridium Difficile Infections-Clostridium Difficile Associated Disease-Pipeline Insight, 2025

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.

Geography Covered

• Global coverage

Clostridium Difficile Infections: Understanding

Clostridium Difficile Infections: Overview

Clostridium difficile (C. difficile) is a Gram-positive, spore-forming, anaerobic bacillus, which is widely distributed in the intestinal tract of humans and animals and in the environment. In the last decade, the frequency and severity of C. difficile infection has been increasing worldwide to become one of the most common hospital-acquired infections. Transmission of this pathogen occurs by the fecal-oral route and the most important risk factors include antibiotic therapy, old age, and hospital or nursing home stay.

C. difficile colonizes in the large intestine of humans. Healthy adults with adequate immune response become asymptomatic carriers of the disease. Neonates also have a high rate of asymptomatic carrier rate, owing to a lack of intestinal receptors for C. difficile. The use of antibiotics alters the microbial flora of the large intestine, rendering it susceptible to infection by C. difficile, and the transmission of the disease occurs through the fecal-oral route. Diarrhea and colitis, the hallmark features of C. difficile infection, are caused by clostridial glycosylation exotoxins, toxin A (TcdA) which is enterotoxin, and toxin B (TcdB) which is cytotoxic. A few pathological strains produce an additional toxin known as a binary toxin, the role of which is not elucidated. Toxin A has a carbohydrate receptor binding site that facilitates the intracellular transport of both toxin A, and toxin B. After becoming intracellular, both the toxins cause inactivation of pathways mediated by the Rho family of proteins, resulting in damage of colonocytes, disruption of intercellular tight junctions, and colitis. Toxin-A causes direct activation of neutrophils while both toxin A and toxin B are involved in the chemotaxis of neutrophils.

The management of C. difficile infection includes a multi-step approach of discontinuing the usage of inciting antibiotics, isolating the patient, and administering the antibiotic based on the severity of the infection. The antibiotics usually used in the treatment of C. difficile infection are vancomycin or fidaxomicin. Asymptomatic patients despite having a positive stool toxin test do not require treatment. Intravenous metronidazole can be used in a patient who suffers from ileus where the delivery of orally administered antibiotics will be delayed. However, vancomycin cannot be administered intravenously because it cannot be secreted into the colon. Surgical intervention such as subtotal colectomy with preservation of the rectum may be required in certain patients who develop fulminant colitis leading to complications such as toxic megacolon, intestinal perforation, and necrotizing colitis. The first recurrence of C. difficile infection can be treated with a prolonged taper and pulsed vancomycin regimen which is 125 mg, 4 times per day for 10 to 14 days, 2 times per day for 7 days, one time a day for 7 days, and lastly, once every 2 to 3 days for 2 to 8 weeks or fidaxomicin 200 mg, 2 times per day for 10 days if vancomycin was used for the initial episode. A second or further recurrence can be treated with a taper and pulsed vancomycin regimen as mentioned for the first recurrence, vancomycin 125 mg orally, 4 times per day for 10 days followed by rifaximin 400 mg orally, 3 times per day for 20 days, fidaxomicin 200 mg, 2 times per day for 10 days, OR fecal transplantation. Bezlotoxumab, a human monoclonal antibody against C. difficile toxin, has been approved for the management of recurrent infections by C. difficile and a clinical study performed to assess the efficacy revealed positive outcomes. Fecal transplantation, the process through which feces from a healthy donor into the intestinal tract of a person with disrupted microbial balance, has reported an 80% to 90% success rate in reducing the recurrence of C. difficile infections.

""Clostridium Difficile Infections- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Clostridium Difficile Infections pipeline landscape is provided which includes the disease overview and Clostridium Difficile Infections treatment guidelines. The assessment part of the report embraces, in depth Clostridium Difficile Infections commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Clostridium Difficile Infections collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Clostridium Difficile Infections R&D. The therapies under development are focused on novel approaches to treat/improve Clostridium Difficile Infections.

Clostridium Difficile Infections Emerging Drugs Chapters

This segment of the Clostridium Difficile Infections report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Clostridium Difficile Infections Emerging Drugs

• VE303: Vedanta Biosciences

VE303 is a defined bacterial consortium therapeutic candidate designed for the prevention of recurrent Clostridioides difficile infection (rCDI). It consists of eight strains that were rationally selected using Vedanta’s discovery engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition. Vedanta reported positive topline results in October 2021 from the Phase 2 CONSORTIUM trial, in which VE303 was associated with a 31.7% absolute risk reduction in the rate of recurrence when compared with placebo, representing a greater than 80% reduction in the odds of a CDI recurrence. Additionally, the positive results of the Phase 2 study, first reported in October 2021, triggered a $23.8 million contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support a Phase 3 clinical study of VE303. This project has been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A5012C00177 for a contract value up to $81.9 million. VE303 was granted Orphan Drug Designation in 2017 and Fast Track Designation in 2023 by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent CDI. Currently, the drug is in the Phase III stage of its development for the treatment of Clostridium Difficile Infections.

• 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.

• ADS 024: Adiso Therapeutics

ADS024 is an oral single strain live biotherapeutic product (SS-LBP). A naturally occurring live biotherapeutic product, ADS024 possesses a dual mechanism of action. It is bactericidal toward Clostridioides difficile and degrades Toxins A and B produced by C. difficile while maintaining other components of the microbiome. ADS024 is a single strain multimodal LBP and is manufactured from a pure, clonal bacterial cell bank, yielding a standardized lyophilized drug product eliminating the need to directly source from donor fecal material. Currently, the drug is in the Phase I stage of its development for the treatment of Clostridium Difficile Infections.

Further product details are provided in the report……..

Clostridium Difficile Infections: Therapeutic Assessment

This segment of the report provides insights about the different Clostridium Difficile Infections drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Clostridium Difficile Infections
• There are approx. 20+ key companies which are developing the therapies for Clostridium Difficile Infections. The companies which have their Clostridium Difficile Infections drug candidates in the most advanced stage, i.e. phase III include, Vedanta Biosciences
• Phases

DelveInsight’s report covers around 22+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

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
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Clostridium Difficile Infections: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Clostridium Difficile Infections therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Clostridium Difficile Infections drugs.

Clostridium Difficile Infections Report Insights

• Clostridium Difficile Infections Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Clostridium Difficile Infections Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Clostridium Difficile Infections drugs?
• How many Clostridium Difficile Infections drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Clostridium Difficile Infections?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Clostridium Difficile Infections therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Clostridium Difficile Infections and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

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

Key Products

• VE303
• ADS 024
• Ibezapolstat
• RBX7455
• Full Spectrum Microbiota
• MBK-01
• MGB-BP-3
• CRS3123
• VE303
• DNV 3837
• LMN 201
• IM-01
• DNV3837

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