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Clostridium Difficile Infection

16
Pipeline Programs
23
Companies
22
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
5
0
6
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
5100%
+ 30 programs with unclassified modality

On Market (1)

Approved therapies currently available

Merck & Co.
ZINPLAVAApproved
bezlotoxumab
Merck & Co.
injection2016
632K Part D

Competitive Landscape

19 companies ranked by most advanced pipeline stage

Merck & Co.
Merck & Co.RAHWAY, NJ
4 programs
1
BezlotoxumabN/AMonoclonal Antibody
Bezlotoxumab Injection [Zinplava]N/A
microbiome analysisN/A
MK-6072PHASE_3
Biocorp
BiocorpFrance - Issoire
1 program
1
Bio K+® 2 capsules orallyPhase 41 trial
Active Trials
NCT01972932Terminated60Est. Aug 2017
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
fidaxomicinPhase 41 trial
Active Trials
NCT02464306Withdrawn0Est. Jun 2019
MSD
MSDIreland - Ballydine
6 programs
3
BezlotoxumabPhase 3Monoclonal Antibody1 trial
MK-3415Phase 31 trial
MK-6072Phase 31 trial
BezlotoxumabN/AMonoclonal Antibody1 trial
Bezlotoxumab Injection [Zinplava]N/A1 trial
+1 more programs
Active Trials
NCT04317963Completed180Est. Feb 2023
NCT04075422Completed869Est. Oct 2022
NCT04259931Unknown50Est. Jun 2021
+3 more trials
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
6 programs
3
BezlotoxumabPhase 3Monoclonal Antibody
MK-3415Phase 3
MK-6072Phase 3
BezlotoxumabN/AMonoclonal Antibody
Bezlotoxumab Injection [Zinplava]N/A
+1 more programs
Syneos Health
Syneos HealthNC - Morrisville
2 programs
1
MGB-BP-3Phase 21 trial
DAV132N/A1 trial
Active Trials
NCT03710694Completed260Est. Aug 2019
NCT03824795Completed34Est. Apr 2020
Finch Therapeutics
1 program
1
CP101Phase 21 trial
Active Trials
NCT03497806Completed132Est. Apr 2021
Medpace
MedpaceCINCINNATI, OH
1 program
1
CP101Phase 2
MGB Biopharma
MGB BiopharmaUK - Bellshill
1 program
1
MGB-BP-3Phase 2
Osel
OselCA - Mountain View
1 program
1
MIYA-BM Fine GranulesPhase 21 trial
Active Trials
NCT01077245Withdrawn0Est. Nov 2013
Immuron
ImmuronAustralia - Blackburn North
1 program
1
IMM-529Phase 1/21 trial
Active Trials
NCT03065374Terminated9Est. Nov 2019
Valneva
ValnevaAustria - Vienna
1 program
1
IC84Phase 11 trial
Active Trials
NCT01296386Completed82Est. Apr 2013
Astellas
AstellasChina - Shenyang
2 programs
Environmental samplingN/A1 trial
FidaxomicinN/A1 trial
Active Trials
NCT02461901Completed203Est. Dec 2017
NCT02214771Completed296Est. Aug 2017
Seres Therapeutics
Seres TherapeuticsCAMBRIDGE, MA
2 programs
SER-262PHASE_11 trial
SER-109PHASE_31 trial
Active Trials
NCT02830542Completed96Est. Aug 2018
NCT03183128Completed182Est. Sep 2020
Otsuka
OtsukaJapan - Tokushima
1 program
CDI PtsN/A1 trial
Active Trials
NCT02223715Completed600Est. Jan 2015
Pfizer
PfizerNEW YORK, NY
1 program
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in KoreaN/A1 trial
Active Trials
NCT04567134Unknown500Est. Dec 2022
Innovation Pharmaceuticals
1 program
Fecal microbiota transplantionN/A1 trial
Active Trials
NCT04885946Unknown42Est. Dec 2024
Eppendorf
EppendorfGermany - Hamburg
1 program
Infection ControlN/A1 trial
Active Trials
NCT03250104Completed80,000Est. Jul 2019
Plus Therapeutics
1 program
Bio K+® 2 capsules orallyPHASE_4

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Colorado Therapeuticsfidaxomicin
BiocorpBio K+® 2 capsules orally
MSDBezlotoxumab
Seres TherapeuticsSER-109
MSDMK-6072
MSDMK-3415
Syneos HealthMGB-BP-3
Finch TherapeuticsCP101
OselMIYA-BM Fine Granules
ImmuronIMM-529
Seres TherapeuticsSER-262
ValnevaIC84
Innovation PharmaceuticalsFecal microbiota transplantion
PfizerClostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
MSDmicrobiome analysis

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 86,398 patients across 22 trials

Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection

Start: Jun 2018Est. completion: Jun 20190
Phase 4Withdrawn
NCT01972932BiocorpBio K+® 2 capsules orally

Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea

Start: Nov 2013Est. completion: Aug 201760 patients
Phase 4Terminated
NCT03182907MSDBezlotoxumab

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

Start: Mar 2018Est. completion: May 2022148 patients
Phase 3Completed

ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

Start: Jul 2017Est. completion: Sep 2020182 patients
Phase 3Completed

A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)

Start: Feb 2012Est. completion: May 20151,203 patients
Phase 3Completed

A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)

Start: Oct 2011Est. completion: Dec 20141,452 patients
Phase 3Completed

Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

Start: Feb 2019Est. completion: Apr 202034 patients
Phase 2Completed

Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Start: May 2018Est. completion: Apr 2021132 patients
Phase 2Completed
NCT01077245OselMIYA-BM Fine Granules

Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections

Start: Feb 2010Est. completion: Nov 20130
Phase 2Withdrawn

Treatment for Clostridium-difficile Infection With IMM529

Start: Sep 2017Est. completion: Nov 20199 patients
Phase 1/2Terminated

SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Start: Aug 2016Est. completion: Aug 201896 patients
Phase 1Completed

An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84

Start: Dec 2010Est. completion: Apr 201382 patients
Phase 1Completed
NCT04885946Innovation PharmaceuticalsFecal microbiota transplantion

Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

Start: Jun 2021Est. completion: Dec 202442 patients
N/AUnknown
NCT04567134PfizerClostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Start: Oct 2020Est. completion: Dec 2022500 patients
N/AUnknown
NCT04259931MSDmicrobiome analysis

PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA

Start: Mar 2020Est. completion: Jun 202150 patients
N/AUnknown
NCT04317963MSDBezlotoxumab

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

Start: Feb 2020Est. completion: Feb 2023180 patients
N/ACompleted
NCT04075422MSDBezlotoxumab Injection [Zinplava]

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

Start: Oct 2019Est. completion: Oct 2022869 patients
N/ACompleted

Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)

Start: Oct 2018Est. completion: Aug 2019260 patients
N/ACompleted
NCT03250104EppendorfInfection Control

Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives

Start: Nov 2016Est. completion: Jul 201980,000 patients
N/ACompleted
NCT02461901AstellasEnvironmental sampling

Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Start: Jan 2015Est. completion: Dec 2017203 patients
N/ACompleted

Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients

Start: Sep 2014Est. completion: Aug 2017296 patients
N/ACompleted

Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries

Start: Mar 2014Est. completion: Jan 2015600 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs, potential near-term approvals
23 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.