bezlotoxumab
Trade name: zinplava
mAbapprovedFast Track FDA
Approved
Oct 21, 2016
Bezlotoxumab, sold under the brand name Zinplava, is a human monoclonal antibody designed for the prevention of recurrence of Clostridioides difficile infections. Bezlotoxumab binds to Clostridioides difficile toxin B. — Wikipedia
Clinical trial activity
12 trials · 45 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
6
Phase 3
3
Phase 4
6
Earliest trial started Jul 1, 2006 (NCT00350298)
Timeline
Indications
Approved for
Studied for
- Clostridioides difficile · Phase 4
- Clostridium Infections · Phase 4
- Colitis, Ulcerative · Phase 4
- Crohn Disease · Phase 4
- Enterocolitis, Pseudomembranous · Phase 4
- Gastrointestinal Microbiome · Phase 2
- Infections · Phase 2
- Inflammatory Bowel Diseases · Phase 4
- Mortality · Phase 2
- Organ Dysfunction Scores · Phase 2
- Sepsis · Phase 4
Mechanism of action
- Botulinum neurotoxin type AINHIBITOR
botA inhibitor
- Toxin BINHIBITOR
tcdB inhibitor
- Insulin-like growth factor IINHIBITOR
IGF1 inhibitor
- Clostridium difficileImmunity, passive
Clostridium difficile immunity, passive
Approval history
- approvedPriority reviewFast trackOct 21, 2016
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
First in class
Sources
- WikipediaBezlotoxumab ↗
- NCATS4H5YMK1H2E ↗
- ChEMBLCHEMBL2109314 ↗
- ChEMBLCHEMBL2109313 ↗
- ChEMBLCHEMBL2108670 ↗
Also known as
- bezlotoxumab
- bezlotoxumab
- bezlotoxumab
- bezlotoxumab
- bezlotoxumab
- bezlotoxumab
- bezlotoxumab
- bezlotoxumab
- gs-cda1
- gs-cda1
- mdx-1388
- mdx-1388
- mk-6072
- mk-6072
- mk-6072
- zinplava
- zinplava
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05304715 | Phase 2 | Apr 13, 2022 | Hellenic Institute for the Study of Sepsis, Hellenic Sepsis Study Group |
| NCT05077085 | Phase 4 | Jan 31, 2022 | Erasmus University Rotterdam, Leiden University, Medical Center Haaglanden, OLVG hospital, Amsterdam, University of Amsterdam |
| NCT04626947 | Phase 4 | Nov 30, 2020 | Merck, University of Pittsburgh |
| NCT04415918 | Phase 4 | Jul 1, 2020 | Cooper Human Systems |
| NCT03937999 | Phase 4 | Jul 8, 2019 | Merck, Yeshiva University |
| NCT03880539 | Phase 4 | Jun 10, 2019 | Merck, University of Kansas |
| NCT03756454 | Phase 4 | Apr 30, 2019 | Merck, Ohio State University |
| NCT03829475 | Phase 2 | Mar 1, 2019 | Harvard University |
| NCT03182907 | Phase 3 | Dec 1, 2017 | Merck |
| NCT01513239 | Phase 3 | Feb 1, 2012 | Merck |
| NCT01241552 | Phase 3 | Oct 1, 2011 | Merck |
| NCT00350298 | Phase 2 | Jul 1, 2006 | Baylor University, Central Indiana Gastroenterology Group, Centre de Sante et de Services Sociaux de Chicoutimi, Centre Hospitalier Regional de Trois-Rivieres, Chest, Infectious Diseases and Critical Care Assoc., PC, Dr. Kiran C. Patel Research Institute, Henry Ford Health System, Icahn School of Medicine at Mount Sinai, Idaho Falls Infectious Diseases, PLLC, Jersey Shore University Medical Center, Kaiser Permanente, Mayo Clinic, Medarex, Mercury Street Medical Group, MultiCare Health System Research Institute, PMG Research, Queen's University, Belfast, Rapid City Regional Hospital, Remington-Davis Clinical Research, Saint Luke's Health System, Summa Health System, Texas A&M University, Thomas Jefferson University, University of Calgary, University of California, Los Angeles, University of Kentucky, University of Manitoba, University of Massachusetts, University of Southern California, Vancouver Island Health Research Centre, Windsor Regional Hospital |
Showing 12 of 12 trials
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Organizations
Research & Development (45)
45 organizations
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