Clostridium Difficile Infection

4
Pipeline Programs
7
Companies
13
Clinical Trials
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 8 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Plus Therapeutics
1 program
1
Bio K+® 2 capsules orallyPhase 41 trial
Active Trials
NCT01972932TerminatedEst. Aug 2017
M&
Merck & Co.RAHWAY, NJ
4 programs
1
MK-6072Phase 31 trial
BezlotoxumabN/AMonoclonal Antibody1 trial
Bezlotoxumab Injection [Zinplava]N/A1 trial
microbiome analysisN/A1 trial
Active Trials
NCT04317963Completed180Est. Feb 2023
NCT04075422Completed869Est. Oct 2022
NCT04259931Unknown50Est. Jun 2021
+1 more trials
Seres Therapeutics
Seres TherapeuticsCAMBRIDGE, MA
2 programs
1
1
SER-109Phase 31 trial
SER-262Phase 11 trial
Active Trials
NCT02830542CompletedEst. Aug 2018
NCT03183128CompletedEst. Sep 2020
Pfizer
PfizerNEW YORK, NY
1 program
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in KoreaN/A1 trial
Active Trials
NCT04567134Unknown500Est. Dec 2022
Astellas
AstellasChina - Shenyang
1 program
FidaxomicinN/A5 trials
Active Trials
NCT02437591Completed25Est. Oct 2016
NCT02218372Completed148Est. Mar 2018
NCT02461901Completed203Est. Dec 2017
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstellasFidaxomicin
Plus TherapeuticsBio K+® 2 capsules orally
Seres TherapeuticsSER-109
AstellasFidaxomicin
AstellasFidaxomicin
Merck & Co.MK-6072
Seres TherapeuticsSER-262
PfizerClostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Merck & Co.microbiome analysis
Merck & Co.Bezlotoxumab
Merck & Co.Bezlotoxumab Injection [Zinplava]
AstellasFidaxomicin
AstellasFidaxomicin

Clinical Trials (13)

Total enrollment: 3,684 patients across 13 trials

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

Start: Aug 2015Est. completion: Oct 201625 patients
Phase 4Completed
NCT01972932Plus TherapeuticsBio 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 2017
Phase 4Terminated

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

Start: Jul 2017Est. completion: Sep 2020
Phase 3Completed

A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Start: Jan 2015Est. completion: Mar 2018148 patients
Phase 3Completed

A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Start: Jun 2014Est. completion: Sep 2016210 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

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

Start: Aug 2016Est. completion: Aug 2018
Phase 1Completed
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
NCT04259931Merck & Co.microbiome 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

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

Start: Feb 2020Est. completion: Feb 2023180 patients
N/ACompleted
NCT04075422Merck & Co.Bezlotoxumab 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

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

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
7 companies competing in this space