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ZINPLAVA

(Bezlotoxumab)

ApprovedMonoclonal antibody

ZINPLAVA is one of 75 biologic programs targeting Mortality. It is currently in Approved.

3

Indications

11

Total Trials

0

Active Trials

74

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MortalityActive, not recruiting

Clostridium Difficile InfectionActive, not recruiting

Clostridioides Difficile InfectionActive, not recruiting

MortalityApproved

Active, not recruiting

Clostridium Difficile InfectionApproved

Active, not recruiting

Clostridioides Difficile InfectionPreclinical

Active, not recruiting

Competition

Competitive Landscape

108 competitors in Mortality

#DrugCompanyPhaseTrials

Winrevair

Crestor

Mounjaro

ZINPLAVA

Deltavit

HHyundai Pharmaceutical Co., LTD.

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Diflucan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Clostridium Difficile Infection4 trials

Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

Terminated·—·Phase 4·NCT04626947·19 enrolled

Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03182907·148 enrolled

Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.

Completed·FFundacion SEIMC-GESIDA··NCT04075422·869 enrolled

Show 1 more trial

Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection

Completed·UUniversity of Kansas Medical Center·Phase 4·NCT03880539·4 enrolled

Clostridioides difficile Infection2 trials

Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

Completed·UUniversity of Illinois at Chicago··NCT04317963·180 enrolled

Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Completed·HHellenic Institute for the Study of Sepsis·Phase 2·NCT05304715·44 enrolled

MPA1 trial

ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

Completed·—·Phase 2·NCT03829475·61 enrolled

Efficacy1 trial

Bezlotoxumab Efficacy and Tolerability in Cancer Patient

Unknown status·TThe Cooper Health System·Phase 4·NCT04415918·132 enrolled

Recurrent1 trial

Bezlotoxumab Versus FMT for Multiple Recurrent CDI

Withdrawn·LLeiden University Medical Center·Phase 4·NCT05077085

2 more indications

Hospitalized Patients1 trial

Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

Terminated·MMontefiore Medical Center·Phase 4·NCT03937999·1 enrolled

Mortality1 trial

Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.

Terminated·—·Phase 4·NCT03756454·5 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 21, 2016

ZINPLAVA

BLA BLA761046

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Bezlotoxumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bezlotoxumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bezlotoxumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761046). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Merck & Co.

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