Drugs / Bezlotoxumab
Bezlotoxumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Clostridium difficile colitis 1 milestone | |||||
| Filed | EU (EMA) | — | Clostridium difficile colitis | — | “The company also has filed a marketing authorization application for bezlotoxumab with the European Medicines Agency (EMA) that is currently under review.” merck.com ↗ “The company also has filed a MAA for bezlotoxumab with the EMA that is currently under review.” merck.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | ZINPLAVA | — | 2023-05-26 | fda.gov ↗ |
| Approved | EU (EMA) | Zinplava | — | 2017-01-18 | europa.eu ↗ |
| Approved | US (FDA) | ZINPLAVA | — | 2016-10-21 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03829475 | Jan 2020 → Aug 2023 | Clostridium difficile colitis | Brigham and Women's Hospital | Completed | Missed primary |
| Phase 2 | NCT00350298 | Jul 2006 → Jun 2008 | Clostridium difficile colitis | MassBiologics | Completed | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT03182907 | Mar 2018 → May 2022 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01513239 | Feb 2012 → May 2015 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01241552 | Oct 2011 → Dec 2014 | Clostridium difficile colitis | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 46 trials | ||||||
| Phase 4 | NCT05077085 | Jan 2022 → Jul 2024 | Clostridium difficile colitis, Clostridium infectious disease | Leiden University Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT04626947 | Oct 2021 → Apr 2024 | Clostridium difficile colitis, Crohn disease, ulcerative colitis | David Binion, MD | Terminated | No outcome recorded |
| Phase 4 | NCT04415918 | Jul 2020 → Jul 2021 | Clostridium difficile colitis | The Cooper Health System | Unknown | No outcome recorded |
| Phase 4 | NCT03937999 | Aug 2019 → May 2022 | Clostridium difficile colitis | Montefiore Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03756454 | Aug 2019 → May 2022 | Clostridium difficile colitis, Clostridium infectious disease | Ohio State University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03880539 | Jun 2019 → Nov 2021 | Clostridium difficile colitis | University of Kansas Medical Center | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05304715 Comparator | Apr 2022 → Jun 2023 | Clostridium difficile colitis, multiple organ dysfunction syndrome | Hellenic Institute for the Study of Sepsis | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2016-10-21 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s ZINPLAVA™ (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL. |
| 2016-07-21 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab merck.com ↗
The additional data and analyses constitute a major amendment to the BLA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months. |
| 2016-06-09 | Merck Sharp & Dohme LLC | Regulatory Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA™ (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence merck.com ↗
The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. difficile infection recurrence in patients aged 18 years and older. |
| 2016-01-27 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile ( C. difficile ) infection recurrence. |
| 2015-09-20 | Merck Sharp & Dohme LLC | Results Pivotal Phase 3 Studies of Bezlotoxumab, Merck’s Investigational Antitoxin to Prevent Clostridium Difficile Infection Recurrence, Met Primary Endpoint merck.com ↗ |
All press releases naming this drug 5 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bezlotoxumab | “Bezlotoxumab is a human monoclonal antibody against Clostridium difficile toxin B” PMID 32376702 ↗ May 2020 |
| Known as | BEZLO | “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...” NCT03829475 ↗1“bezlotoxumab (BEZLO), an approved monoclonal antibody targeting C. difficile toxin” NCT03880539 ↗ |
| Known as | MBL-CDB1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108670 ↗ |
| Known as | MDX-1388 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00350298 ↗ |
| Known as | MK-6072 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01241552 ↗ |
| Known as | Zinplava | “A single dose of Bezlotoxumab (Zinplava) 10mg/kg (actual body weight) 60-minute intravenous infusion during active CDI treatments.” NCT04415918 ↗1“Zinplava™(bezlotoxumab) is an FDA approved human monoclonal antibody designed to prevent the recurrence of C.diff.” NCT03937999 ↗ |
| Modality | Monoclonal antibody | “a human monoclonal antibody to C. difficile toxin B (MDX-1388)” NCT00350298 ↗ |
| Route | Intravenous | “Single IV infusion of 10 mg/kg MK-6072” NCT01241552 ↗ |