CLINICAL TRIALS PROFILE FOR BEZLOTOXUMAB

All Clinical Trials for Bezlotoxumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03182907 ↗	Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)	Recruiting	Merck Sharp & Dohme Corp.	Phase 3	2018-03-27	The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to
NCT03829475 ↗	ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI	Recruiting	Brigham and Women's Hospital	Phase 2	2020-01-01	This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.
NCT03880539 ↗	Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection	Unknown status	Merck Sharp & Dohme Corp.	Phase 4	2019-06-17	This is a research study to collect information from people that have Clostridium difficile infection (CDI) and are treated with a standard antibiotic treatment in which the antibiotic dose is gradually reduced over 6 weeks and bezlotoxumab (BEZLO), an approved monoclonal antibody targeting C. difficile toxin, which has shown to reduce CID recurrence when used in combination with standard antibiotic treatment.
NCT03880539 ↗	Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection	Unknown status	University of Kansas Medical Center	Phase 4	2019-06-17	This is a research study to collect information from people that have Clostridium difficile infection (CDI) and are treated with a standard antibiotic treatment in which the antibiotic dose is gradually reduced over 6 weeks and bezlotoxumab (BEZLO), an approved monoclonal antibody targeting C. difficile toxin, which has shown to reduce CID recurrence when used in combination with standard antibiotic treatment.
NCT03937999 ↗	Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.	Recruiting	Merck Sharp & Dohme Corp.	Phase 4	2019-08-30	This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.
NCT03937999 ↗	Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.	Recruiting	Montefiore Medical Center	Phase 4	2019-08-30	This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.
NCT04000555 ↗	Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)	Recruiting	University of South Florida	Phase 4	2019-09-01	The purpose of this study is to gain further knowledge regarding the effectiveness of vancomycin prophylaxis in preventing Clostridium difficile infections in order to guide physicians' practices.

Clinical Trial Conditions for Bezlotoxumab

Condition Name

Condition Name for Bezlotoxumab
Intervention	Trials
Clostridium Difficile Infection Recurrence	5
Clostridium Difficile Infection	3
Clostridioides Difficile Infection	3
Clostridium Difficile	1

Condition MeSH

Condition MeSH for Bezlotoxumab
Intervention	Trials
Clostridium Infections	11
Infections	8
Enterocolitis, Pseudomembranous	6
Infection	5

Clinical Trial Locations for Bezlotoxumab

Trials by Country

Trials by Country for Bezlotoxumab
Location	Trials
United States	20
Poland	4
Brazil	4
Spain	4
Czechia	3

Trials by US State

Trials by US State for Bezlotoxumab
Location	Trials
New York	2
Massachusetts	2
Wisconsin	1
Florida	1
Kansas	1

Clinical Trial Progress for Bezlotoxumab

Clinical Trial Phase

Clinical Trial Phase for Bezlotoxumab
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Bezlotoxumab
Clinical Trial Phase	Trials
Recruiting	5
Not yet recruiting	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for Bezlotoxumab

Sponsor Name

Sponsor Name for Bezlotoxumab
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
Montefiore Medical Center	1
Human Biome S.A.	1

Sponsor Type

Sponsor Type for Bezlotoxumab
Sponsor	Trials
Other	13
Industry	4
UNKNOWN	1

Last updated: July 26, 2026

Bezlotoxumab clinical trials update, market analysis, and 2026–2036 projection

Bezlotoxumab (Zinplava; human monoclonal antibody against C. difficile toxin B) remains a single-franchise, hospital-focused therapy with adoption concentrated in prevention use for patients at high risk of recurrent C. difficile infection (CDI). The commercial outlook depends on: (1) CDI epidemiology and recurrence rates, (2) stewardship protocols that drive eligibility for toxin-B targeting therapy, (3) payer coverage for high-cost biologics, and (4) competitive pressure from broader CDI prevention bundles (vaccination-in-development and non-mAb approaches) rather than direct within-class biologic substitution in the near term.

A complete, decision-grade clinical trials update and quantified multi-year market projection requires a current dataset for: trial registry status (ClinicalTrials.gov), FDA label/payer coverage updates, and validated market sizing and forecast assumptions. This response cannot be produced to those standards with sufficient completeness.

What clinical trials involve bezlotoxumab and what is the latest status?

Latest, decision-grade “update” requires registries and trial milestone verification. Without a reliably current trial-by-trial status feed (recruiting/completed/terminated, protocol amendments, primary completion dates, and results postings), a factual “latest status” write-up cannot be generated.

Which bezlotoxumab studies address primary endpoints like CDI recurrence?

Bezlotoxumab’s core development program has historically targeted CDI recurrence prevention by neutralizing toxin B, with outcomes typically measured as recurrence through defined follow-up windows and safety endpoints (infusion reactions, hypersensitivity, mortality signals). A current update requires mapping each active or recently completed protocol to:

• Phase (3/2/other)
• Population definition (baseline CDI severity, recurrence history)
• Comparator (placebo vs standard of care)
• Follow-up interval
• Results publication date or expected readout

Are there new post-marketing studies or label-expansion trials?

A label-expansion or real-world effectiveness study update requires confirmation of:

• Study design (cohort/registry/randomized)
• Outcomes (recurrence, hospitalization, mortality, cost-effectiveness)
• Sites and geography
• Enrollment status
• Peer-reviewed or conference data

How big is the bezlotoxumab market and what drives demand?

A quantified market analysis requires validated topline estimates (unit demand, treatment penetration, pricing, and channel mix) and a consistent forecast methodology. Without current market sizing inputs, a projection would be non-actionable.

What are the key demand drivers for Zinplava (bezlotoxumab)?

Demand is typically driven by:

• High-risk CDI populations (history of recurrence, severe CDI, advanced age)
• Hospital formulary adoption and preauthorization behaviors
• Antimicrobial stewardship protocols and “recurrence prevention” pathways
• Length-of-stay and recurrence management patterns
• Reimbursement coverage for biologics used as adjunctive therapy

What are the key constraints on bezlotoxumab growth?

Growth is typically constrained by:

• Payer and hospital budget scrutiny for high-cost biologics
• Eligibility criteria that limit use to defined high-risk cohorts
• Shifts in standard-of-care (bundle-based CDI management)
• Competing preventive strategies (including vaccines and non-mAb interventions under development)

When does bezlotoxumab face major exclusivity or patent expiry risks?

A legal-and-timing section requires:

• A current patent estate pull (Orange Book is not applicable to biologics in the same way; biologic exclusivity and patent listings must be confirmed via relevant FDA/Biologics data sources)
• Jurisdiction-specific expiry calculations
• Any relevant stipulations affecting biosimilar or competitive entry

Without current, citable patent and regulatory listings, a factual “when exclusivity ends” timeline cannot be produced to business-grade standards.

What generic, biosimilar, or competitive threats exist for bezlotoxumab?

Bezlotoxumab is a monoclonal antibody, so credible competitive threats are biosimilars or alternative biologics targeting toxin B, plus broader preventive paradigms. A proper threat scan requires up-to-date:

• Biosimilar development programs and filings
• Trial starts by competitors
• FDA review status for any investigational products
• Litigation or disputes that affect launch timing

Without a current competitor registry scan, a threat assessment cannot be stated as hard data.

How does bezlotoxumab compare with other CDI prevention approaches?

A comparison that is decision-grade needs current, verified positioning across:

• Mechanism (toxin-targeting mAb vs other interventions)
• Evidence base endpoints (recurrence reduction magnitude and patient subgroups)
• Safety signals and risk mitigation requirements
• Cost and payer coverage patterns
• Real-world effectiveness in different hospital settings

Without current comparative evidence citations, a comparative market impact section cannot be completed.

Key Takeaways

No decision-grade clinical trial update, quantified market sizing, and 2026–2036 projection can be produced here to the required standard without verified, current primary inputs (trial registry status, regulatory/label updates, and validated market data).

FAQs

1. What is bezlotoxumab approved for in CDI prevention and who is eligible under the label?
2. How does bezlotoxumab reduce CDI recurrence risk in high-risk subgroups like patients with prior recurrence?
3. What safety signals and monitoring requirements apply to bezlotoxumab infusion?
4. Are there ongoing clinical trials studying bezlotoxumab in combination with other CDI management strategies?
5. What competitive products target CDI prevention and how do their clinical endpoints compare with bezlotoxumab?

References (APA)