Drugs / Bezlotoxumab
Bezlotoxumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
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 ↗ |