Zinplava (bezlotoxumab) / Merck (MSD) - LARVOL DELTA

Current practices and unmet needs in the management of Clostridioides difficile infection in pediatric inflammatory bowel disease: A national survey. (PubMed, J Pediatr Gastroenterol Nutr) - "This nationwide survey highlights substantial unmet needs in CDI management in pediatric IBD, including variability in diagnostic strategies, lack of consensus on first-line therapy, and uncertainty regarding immunosuppressive management, supporting the need for evidence-based pediatric-specific guidelines."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • Ulcerative Colitis

A Post-marketing Portrait of Bezlotoxumab Use – Potential Barriers and Administrative Delays of a Discontinued therapy for Clostridiodes difficile Infection (IDWeek 2026) - No abstract available

P4 data • Infectious Disease

Bezlotoxumab and Short-Term Clinical Outcomes in Patients With Clostridioides difficile Infection: A Propensity-Matched Real-World Study (IDWeek 2026) - No abstract available

Clinical • Clinical data • Real-world • Real-world evidence • Infectious Disease

Bezlotoxumab: A Key Deterrent for Recurrent Hypervirulent Clostridioides difficile (ACG 2026) - "We present a case of recurrent CD requiring bezlotoxumab in addition to oral fidaxomicin and intravenous metronidazole after failure of oral vancomycin and oral fidaxomicin. This case highlights the need to restructure the CD diagnostic algorithm to include earlier hypervirulent strain testing. Figure: Figure 1: Computed tomography of abdomen and pelvis demonstrating inflammatory changes of the sigmoid colon with peri-appendiceal fat stranding"

Endocrine Disorders • Hypotension • Infectious Disease • Metabolic Disorders

National Trends in Medicare Part D and Medicaid Utilization and Spending of Bezlotoxumab for Prevention of Recurrent Clostridioides difficile Infection, 2019-2023 (ACG 2026) - "Combined inflation-adjusted spending rose from $535,442 in 2019 to $1,131,221 in 2023 (+111%). In Medicare Part D, real spending increased 78% ($354,708 to $631,513), claims rose 108% (74 to 154), and beneficiaries rose 111% (72 to 152), while real spending per beneficiary fell 16% ($4,926 to $4,155). In Medicaid, real spending rose 177% ($180,734 to $499,708), claims rose 364% (47 to 218), and real spending per claim fell 40% ($3,845 to $2,292)."

Medicaid • Medicare • Reimbursement • US reimbursement • Infectious Disease

Recurrent C. difficile Infection Is Characterized by Repeated Treatment Courses and Rising Costs Under Standard-of-Care Antibiotics (ACG 2026) - "Treatments included vancomycin, metronidazole, fidaxomicin, rifaximin, and/or bezlotoxumab; FDA-approved microbiome therapies were also captured. 11,256 patients with rCDI were identified; mean age was 66.6 (±17.0) years; 62% were aged â¥65 years with a mean Charlson Comorbidity Index of 2.95 (±2.65). In the 6 months before first observed recurrence, 53% had evidence of â¥2 prior treatment regimens, indicating a clinically complex population exposed to multiple successive CDI treatments. Of the 11,256 identified, 9,433 patients met the criteria for first observed line of therapy (LOT); 5,157 (55%) then received the next LOT."

Infectious Disease

Coexist or eliminate? Antibody-based functional silencing versus eradication in gut microbiome- targeted therapy. (PubMed, Front Immunol) - "Drawing on randomized trial data (bezlotoxumab in Clostridioides difficile recurrence prevention, MODIFY I/II, n = 2,655), preclinical and early clinical IgY studies in enteric infections, and long-term IgY deployment in aquaculture, we find that functional silencing delivers durable benefit when disease is driven by discrete virulence factors...Eradication and functional silencing are best understood as complementary strategies whose optimal deployment depends on host immune status, barrier integrity, and the nature of pathobiont virulence. Defining the boundary between safe coexistence and evolutionary rebound constitutes the field's central unresolved challenge."

Journal • Review • Infectious Disease

Post-Marketing Safety Signals of Microbiota-Based Live Biotherapeutic Products for Recurrent Clostridioides difficile Infection: A FAERS Pharmacovigilance Study. (PubMed, Am J Gastroenterol) - "FDA-approved LBPs demonstrate reassuring post-marketing safety profiles without transmitted infection signals. The extreme VOWST UTI signal is likely attributable to FDA-mandated expedited reporting obligations rather than a causal drug effect."

Adverse events • Journal • P4 data • Infectious Disease • Septic Shock • Transplantation • ROR1

Extended-pulsed fidaxomicin versus conventional dosing in patients at high risk of recurrence of Clostridioides difficile infection: a multicentre cohort study. (PubMed, Clin Microbiol Infect) - "This large multicentre cohort study suggests similar effectiveness of both fidaxomicin regimens for preventing CDI recurrence in real-world clinical practice. Time to recurrence from the end of treatment was similar in both groups. Randomised controlled trials are needed to confirm these findings."

Journal • Infectious Disease

A single amino acid substitution determines susceptibility of Clostridioides difficile toxin B variants to monoclonal antibody neutralization. (PubMed, Front Cell Infect Microbiol) - "In this brief report, we uncover the molecular mechanism underlying a key limitation of bezlotoxumab, a monoclonal antibody targeting Clostridioides difficile toxin B (TcdB), specifically its reduced neutralizing activity against certain TcdB variants...Substitution of A2033 with E2033 in TcdB2 restored susceptibility to antibody-mediated neutralization. These findings help define the molecular basis of reduced susceptibility among toxin B variants and may guide the design of next-generation vaccines and antibody-based therapeutics against C. difficile."

Journal

Heart Failure Incidence and Risk Factors in U.S. Adults Receiving Bezlotoxumab: A Large Database Analysis. (PubMed, Infect Dis Rep) - "Bezlotoxumab appears safe in patients without HF history but is associated with a significantly increased risk of HF exacerbation in those with pre-existing HF, especially HFrEF."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Coronary Artery Disease • Dyslipidemia • Heart Failure • Infectious Disease • Nephrology • Renal Disease • Solid Organ Transplantation • Transplantation

Difficile to treat: advanced management strategies in difficult to treat clostridioides difficile infections. (PubMed, Expert Rev Anti Infect Ther) - "The therapeutic landscape has shifted toward fidaxomicin-based antibiotic regimens, and microbiota restoration strategies including standardized microbiota-based products...Evidence is summarized for optimized antibiotic regimens, bezlotoxumab, conventional fecal microbiota transplantation (FMT), FDA-approved microbiota-based products, and salvage strategies including intracolonic therapy and surgery...Implementation requires diagnostic stewardship, earlier recognition of recurrences, clear pathways for microbiota-based therapy access, and multidisciplinary care for fulminant infection. Over the next five years, standardized microbiota therapeutics and better risk tools should shift care toward earlier, more durable recurrence prevention."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Transplantation

MANAGEMENT OF PROTRACTED CLOSTRIDIOIDES DIFFICILE INFECTION IN CHILDREN WITH GI-GVHD AFTER ALLOGENEIC HSCT: A SINGLE-CENTER PEDIATRIC EXPERIENCE (EBMT 2026) - "According to ECIL-10 recommendations, bezlotoxumab and fecal microbiota transplantation (FMT) may be considered in recurrent CDI after vancomycin or fidaxomicin therapy in high-risk patients...Persistent CDI was documented from day +55 despite intensive immunosuppression (cyclosporine A, corticosteroids, ruxolitinib, mesenchymal stromal cells, extracorporeal photopheresis, vedolizumab)...TA-TMA was confirmed and treated with ravulizumab... Management of CDI after allo-HSCT requires a comprehensive and highly individualized approach, as CDI frequently coexists with GI-GvHD and TA-TMA. CDI may exacerbate GI-GvHD, while immunosuppression increases infection severity. Protracted CDI can lead to long-lasting intestinal dysfunction requiring supportive interventions, including teduglutide."

Clinical • Bone Marrow Transplantation • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • Septic Shock • Transplantation Associated Thrombotic Microangiopathy

MANAGEMENT OF PROTRACTED CLOSTRIDIOIDES DIFFICILE INFECTION IN CHILDREN WITH GI-GVHD AFTER ALLOGENEIC HSCT: A SINGLE-CENTER PEDIATRIC EXPERIENCE (EBMT 2026) - "According to ECIL-10 recommendations, bezlotoxumab and fecal microbiota transplantation (FMT) may be considered in recurrent CDI after vancomycin or fidaxomicin therapy in high-risk patients...Persistent CDI was documented from day +55 despite intensive immunosuppression (cyclosporine A, corticosteroids, ruxolitinib, mesenchymal stromal cells, extracorporeal photopheresis, vedolizumab)...TA-TMA was confirmed and treated with ravulizumab... Management of CDI after allo-HSCT requires a comprehensive and highly individualized approach, as CDI frequently coexists with GI-GvHD and TA-TMA. CDI may exacerbate GI-GvHD, while immunosuppression increases infection severity. Protracted CDI can lead to long-lasting intestinal dysfunction requiring supportive interventions, including teduglutide."

Clinical • Bone Marrow Transplantation • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • Septic Shock • Transplantation Associated Thrombotic Microangiopathy

Oral Vancomycin in the Treatment of Clostridioides difficile Infection: A Single-Center Observational Study in Southern Poland (2016-2022), Involving 528,887 Hospitalized Patients. (PubMed, Antibiotics (Basel)) - "The findings underscore the need for improved antimicrobial stewardship, broader access to advanced therapies such as fidaxomicin and bezlotoxumab, and enhanced diagnostic protocols. In settings with restricted therapeutic options, vancomycin remains a valuable treatment, particularly for reducing mortality."

Journal • Observational data • Infectious Disease • Novel Coronavirus Disease

Bezlotoxumab for prevention of Clostridioides difficile recurrence in patients with inflammatory bowel disease: a retrospective multicenter experience. (PubMed, Ann Gastroenterol) - "Bezlotoxumab was commonly combined with vancomycin (61.4%) or fidaxomicin (42.9%), which did not differ between patients with and without IBD. The rCDI rate following bezlotoxumab was similar in patients with and without IBD. In patients with IBD, a history of colorectal surgery or prior vancomycin exposure was more common among those who experienced rCDI."

Journal • Retrospective data • Review • Cardiovascular • Congestive Heart Failure • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease

Pediatric Infectious Diseases Physicians' Preferences for Management of Clostridioides difficile Infection: An Emerging Infections Network (EIN) Survey. (PubMed, J Pediatric Infect Dis Soc) - "We queried pediatric infectious diseases physicians via the Emerging Infections Network regarding management preferences for Clostridioides difficile infection (CDI). We explored use of vancomycin, fidaxomicin, bezlotoxumab and fecal microbiota transplantation and found that physicians are increasingly considering newer and adjunctive therapies for pediatric CDI, highlighting the need for updated guidelines."

Journal • Infectious Disease • Pediatrics • Transplantation

A randomized controlled trial of precision bezlotoxumab treatment for Clostridioides difficile infection. (PubMed, Cell Rep Med) - P=N/A, P2 | "This endpoint was met in 72.7% of patients in the placebo arm and 31.8% in the Bezlotoxumab arm (p = 0.015). Results suggest that BEYOND score can detect early risk in patients with CDI."

Journal • Infectious Disease

Navigating recurrent Clostridioides difficile infection without Bezlotoxumab: potential challenges ahead. (PubMed, Antimicrob Steward Healthc Epidemiol) - No abstract available

Journal • Infectious Disease

Evaluating Utilization Trends of Bezlotoxumab in Patients with Clostridioides difficile Infection to Explore Market Discontinuation (ASHP 2025) - No abstract available

Clinical • Infectious Disease

ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI (clinicaltrials.gov) - P2 | N=61 | Completed | Sponsor: Brigham and Women's Hospital | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Transplantation

Bezlotoxumab As Treatment for Recurrent/Chronic Clostridioides Difficile Infection in Stem Cell Transplant Recipients (ASH 2024) - "However, the safety and efficacy of bezlotuxumab has not been studied in pediatric patients undergoing a SCT, and no data exists to detail its impact on common immunosuppressants such as tacrolimus and mycophenolate mofetil (MMF)...Following relapse of AML, the patient enrolled on a clinical trial to receive a KMT2A inhibitor, revumenib, achieved remission, and eventually proceeded to a second SCT using a single cord donor. The patient's post-SCT course was complicated by Streptococcus mitis/oralisbacteremia, resulting in a long course of broad-spectrum antibiotics with vancomycin and meropenem...At this recurrence, she was hospitalized for dehydration and treated with oral vancomycin, subsequently transitioning to oral fidaxomicin over a 21-day taper...All patients were confirmed to have no gastrointestinal GVHD causing the diarrhea, and no recurrence of diarrhea occurred after bezlotoxumab. This case series strongly suggests the potential utility of bezlotoxumab..."

Clinical • Acute Myelogenous Leukemia • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Pediatrics • Pneumonia • Respiratory Diseases • Transplantation • DEK • KMT2A • NUP214

The monoclonal antibody AZD5148 confers broad protection against TcdB-diverse Clostridioides difficile strains in mice. (PubMed, PLoS Pathog) - "These findings demonstrate that AZD5148 offers broad-spectrum protection against C. difficile strains and retains in vivo efficacy even in the absence of in vitro neutralization. Its distinct mechanism of action and superior potency compared to bezlotoxumab support its continued development as a promising therapeutic candidate for the prevention of a first CDI episode and prevention of recurrence."

Journal • Preclinical • Infectious Disease

Efficacy of Bezlotoxumab in Recurrent Clostridioides difficile Infection: A Systematic Review and Meta-Analysis (ACG 2025) - "The review includes a total of 10 articles that assessed the recurrence rates of CDI infectionfollowing BZX infusion and standard care. There were 2926 patients in the BZX administrationgroup and 2638 patients of the control group. The primary outcome assessed was the oddsratio of recurrence of CDI infection between the 2 groups , the odds of a recurrence of CDI wassignificantly lower in the BZX infusion group in comparison to the standard treatment protocol(OR = 0.59 (0.54; 0.65) , 95% CI; p = 0.67 , I^2 = 0%)."

Retrospective data • Review • Infectious Disease

The Colitis Conundrum: Recurrent C. difficile and CMV Colitis in a Patient With Underlying Ulcerative Colitis (ACG 2025) - "Prior C. diff infections were resistant to vancomycin and metronidazole, only improving with fidaxomicin...He was treated with Bezlotoxumab, but follow-up colonoscopy with biopsy showed pancolitis with CMV-infected cells...He also failed UC treatment with infliximab...Colonoscopy after treatment with fecal live-brpk capsules, ganciclovir, and upadacitinib. Rectosigmoid junction shows quiesced inflammation with endoscopic healing."

Clinical • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis