Skip to main content

Clostridium Difficile

12
Pipeline Programs
14
Companies
14
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
3
0
1
7
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
375%
Vaccine
125%
+ 19 programs with unclassified modality

On Market (1)

Approved therapies currently available

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

Competitive Landscape

13 companies ranked by most advanced pipeline stage

Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
4 programs
2
BezlotoxumabPhase 4Monoclonal Antibody
FidaxomicinPhase 4
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile InfectionN/A
Systematic evaluation by an ID expert.N/A
MSD
MSDIreland - Ballydine
4 programs
2
BezlotoxumabPhase 4Monoclonal Antibody1 trial
FidaxomicinPhase 41 trial
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile InfectionN/A1 trial
Systematic evaluation by an ID expert.N/A1 trial
Active Trials
NCT03586206Unknown45Est. Dec 2020
NCT02951481Completed403Est. Dec 2017
NCT03937999Terminated1Est. May 2022
+1 more trials
Merck & Co.
Merck & Co.RAHWAY, NJ
3 programs
1
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile InfectionN/A
Systematic evaluation by an ID expert.N/A
BezlotoxumabPHASE_4Monoclonal Antibody
Astellas
AstellasChina - Shenyang
3 programs
1
2
FidaxomicinPhase 41 trial
FidaxomicinPhase 4
OPT-80Phase 31 trial
Active Trials
NCT02179658Completed210Est. Sep 2016
NCT01775397Terminated12Est. Apr 2013
Syneos Health
Syneos HealthNC - Morrisville
1 program
1
SER-109Phase 21 trial
Active Trials
NCT02437487Completed89Est. Oct 2016
Theriva Biologics
Theriva BiologicsMD - Rockville
1 program
1
SYN-004Phase 21 trial
Active Trials
NCT02563106Completed413Est. Nov 2016
Valneva
ValnevaAustria - Vienna
1 program
1
VLA84Phase 21 trial
Active Trials
NCT02316470Completed500Est. Oct 2015
Pfizer
PfizerNEW YORK, NY
1 program
1
C. difficile vaccine with adjuvantPhase 1Vaccine1 trial
Active Trials
NCT02052726Completed184Est. May 2015
Becton Dickinson
Becton DickinsonFRANKLIN LAKES, NJ
1 program
Detection and isolation of C. difficile carriersN/A1 trial
Active Trials
NCT03223415Completed4,138Est. May 2018
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Immune Response to C.Difficile InfectionN/A1 trial
Active Trials
NCT02797288Unknown360Est. Jan 2025
Innovation Pharmaceuticals
1 program
PolyhexamethyleneguanidineN/A1 trial
Active Trials
NCT00566306Completed200Est. Aug 2008
Seres Therapeutics
Seres TherapeuticsCAMBRIDGE, MA
1 program
SER-109PHASE_2
Vedanta Biosciences
Vedanta BiosciencesMA - Cambridge
1 program
VE303PHASE_31 trial
Active Trials
NCT06237452Recruiting852Est. Oct 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
MSDBezlotoxumab
MSDFidaxomicin
AstellasFidaxomicin
Vedanta BiosciencesVE303
AstellasOPT-80
Theriva BiologicsSYN-004
Syneos HealthSER-109
ValnevaVLA84
PfizerC. difficile vaccine with adjuvant
MSDRelationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Becton DickinsonDetection and isolation of C. difficile carriers
Allergy TherapeuticsImmune Response to C.Difficile Infection
MSDSystematic evaluation by an ID expert.
Innovation PharmaceuticalsPolyhexamethyleneguanidine

Clinical Trials (14)

Total enrollment: 7,771 patients across 14 trials

NCT03937999MSDBezlotoxumab

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

Start: Aug 2019Est. completion: May 20221 patients
Phase 4Terminated
NCT02254967MSDFidaxomicin

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

Start: Nov 2014Est. completion: May 2016364 patients
Phase 4Completed

A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

Start: Nov 2012Est. completion: Apr 201312 patients
Phase 4Terminated

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Start: May 2024Est. completion: Oct 2027852 patients
Phase 3Recruiting

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 SYN-004 for the Prevention of C.Diff in Patients With a LRTI

Start: Oct 2015Est. completion: Nov 2016413 patients
Phase 2Completed

SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)

Start: May 2015Est. completion: Oct 201689 patients
Phase 2Completed

Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study

Start: Dec 2014Est. completion: Oct 2015500 patients
Phase 2Completed
NCT02052726PfizerC. difficile vaccine with adjuvant

A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

Start: Jan 2014Est. completion: May 2015184 patients
Phase 1Completed
NCT03586206MSDRelationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection

Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection

Start: Sep 2018Est. completion: Dec 202045 patients
N/AUnknown
NCT03223415Becton DickinsonDetection and isolation of C. difficile carriers

Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections

Start: Aug 2017Est. completion: May 20184,138 patients
N/ACompleted
NCT02797288Allergy TherapeuticsImmune Response to C.Difficile Infection

Immune Response to C.Difficile Infection

Start: Mar 2017Est. completion: Jan 2025360 patients
N/AUnknown
NCT02951481MSDSystematic evaluation by an ID expert.

Antimicrobial Stewardship Program for Clostridium Difficile Infection.

Start: Feb 2017Est. completion: Dec 2017403 patients
N/ACompleted
NCT00566306Innovation PharmaceuticalsPolyhexamethyleneguanidine

Influence of a New Polycationic Disinfectant on Clostridium Difficile Incidence and Environmental Colonisation

Start: Feb 2007Est. completion: Aug 2008200 patients
N/ACompleted

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 7,771 patients
14 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.