Bezlotoxumab

Summary

Bezlotoxumab (CHEMBL2108670) is an approved antibody (ATC J06BC03); indicated across 4 conditions including clostridium infectious disease and clostridium difficile colitis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: J06BC03
• Indications: 4 conditions
• Clinical trials: 13

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108670
Name	Bezlotoxumab
Type	Antibody
Max phase	4
ATC	J06BC03

Also known as: Bezlotoxumab, MBL-CDB1, MDX-1388, Mdx-1388, Mk-6072, MK-6072, Zinplava, BEZLOTOXUMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

4 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
Clostridium infectious disease	4	MONDO:0024388	EFO:1000874
Clostridium difficile colitis	4	MONDO:0000705	EFO:1001314

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 13.

Phase distribution

Phase	Trials
PHASE4	6
PHASE3	3
PHASE2	3
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03756454	PHASE4	TERMINATED	Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
NCT03880539	PHASE4	COMPLETED	Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
NCT03937999	PHASE4	TERMINATED	Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
NCT04415918	PHASE4	UNKNOWN	Bezlotoxumab Efficacy and Tolerability in Cancer Patient
NCT04626947	PHASE4	TERMINATED	Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
NCT05077085	PHASE4	WITHDRAWN	Bezlotoxumab Versus FMT for Multiple Recurrent CDI
NCT01241552	PHASE3	COMPLETED	A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
NCT01513239	PHASE3	COMPLETED	A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
NCT03182907	PHASE3	COMPLETED	Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
NCT00350298	PHASE2	COMPLETED	Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
NCT03829475	PHASE2	COMPLETED	ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
NCT05304715	PHASE2	COMPLETED	Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
NCT04317963	Not specified	COMPLETED	Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).