• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Zinplava (bezlotoxumab)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Zinplava (bezlotoxumab)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Zinplava (bezlotoxumab) is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effect. 

    Zinplava is specifically indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.

    Zinplava is supplied as an injection for intravenous infusion. The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. Zinplava must be diluted prior to intravenous infusion. Please see drug label for specific instructions.

    Clinical Results

    FDA Approval

    The FDA approval of Zinplava was based on two phase III trials. MODIFY I and II. MODIFY I enrolled 1,452 patients (median age 65 years) in 19 countries and the MODIFY II study enrolled 1,203 patients (median age 67 years) in 17 countries. The studies were conducted in both hospital and outpatient settings, and the primary endpoint for each study was evaluated through 12 weeks following study drug administration. 

    In the MODIFY I study, patients receiving standard of care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10 mg/kg) (n=403), actoxumab (10 mg/kg) (n=242), the combination of bezlotoxumab and actoxumab (10 mg/kg each) (n=403) or placebo (n=404). The actoxumab arm was stopped for efficacy and safety reasons after an interim analysis. In the MODIFY II study, patients receiving standard of care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10 mg/kg) (n=407), bezlotoxumab and actoxumab (10 mg/kg each) (n=397) or placebo (n=399). In both MODIFY I and MODIFY II, the rate of C. difficile infection recurrence through week 12, the primary efficacy endpoint, was significantly lower in the bezlotoxumab arms (17.4%, p=0.0003) and (15.7%; p=0.0003), and the combination bezlotoxumab and actoxumab arms (15.9%, p<0.0001) and (14.9%, p<0.0001), compared to the placebo arms (27.6%) and (25.7%), respectively. In both studies, the rate of C. difficile infection recurrence was lower in the bezlotoxumab arms compared to the placebo arms in patient subgroups known to be at high risk for C. difficile recurrence, including patients with any prior episode(s) of C. difficile infection within the previous six months, patients infected with the BI/NAP1/027 strain, patients with severe C. difficile infection (Zar score ≥ 2), patients 65 years of age or older, and patients with compromised immunity. 

    Side Effects

    Adverse effects associated with the use of Zinplava may include, but are not limited to, the following: 

    • nausea
    • pyrexia
    • headache

    In addition, heart failure was reported more commonly in Zinplava-treated patients with a history of congestive heart failure (CHF) in the two Phase III clinical trials. In patients with a history of CHF, Zinplava should be reserved for use when the benefit outweighs the risk. 

    Mechanism of Action

    Zinplava (bezlotoxumab) is a human monoclonal antibody that binds C. difficile toxin B with an equilibrium dissociation constant (Kd) of <1×10-9M. Bezlotoxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.

    Additional Information

    For additional information regarding Zinplava or recurrent Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence, please visit http://www.zinplava.com/

    Approval Date: 2016-10-01
    Company Name: Merck
    Back to Listings

    Upcoming Events

    • 15Apr

      Five Telltale Signs You’re Ready for an Electronic TMF System

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    • 06May

      The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Clinical-Trial-Brainstorming

      FDA, Industry Tackle Problem of Including Older Adults in Trials

    • ClinicalTrialNetwork-360x240.png

      National Community-Based Research Network Would Improve Reach of Trials

    • Bottleneck-360x240.png

      Sites Face Trials Bottleneck After Pandemic, But Also Opportunities

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Genetic Research and IBC Oversight Requirements

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing