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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR RIDINILAZOLE


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Clinical Trials for Ridinilazole

Trial ID Title Status Sponsor Phase Summary
NCT02784002 ↗ A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI) Completed Summit Therapeutics Phase 2 The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
NCT03595553 ↗ Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Active, not recruiting Summit Therapeutics Phase 3 Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.
NCT03595566 ↗ To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection Active, not recruiting Summit Therapeutics Phase 3 Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.
NCT04802837 ↗ Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects Recruiting Department of Health and Human Services Phase 3 Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
NCT04802837 ↗ Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects Recruiting Summit Therapeutics Phase 3 Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Ridinilazole

Condition Name

Condition Name for
Intervention Trials
Clostridium Difficile Infection 3
Clostridioides Difficile Infection 3
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Condition MeSH

Condition MeSH for
Intervention Trials
Communicable Diseases 4
Clostridium Infections 4
Infections 4
Infection 4
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Clinical Trial Locations for Ridinilazole

Trials by Country

Trials by Country for
Location Trials
United States 58
Canada 9
Korea, Republic of 6
Australia 4
Brazil 4
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Trials by US State

Trials by US State for
Location Trials
Idaho 4
California 4
Georgia 3
Florida 3
Ohio 3
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Clinical Trial Progress for Ridinilazole

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Active, not recruiting 2
Completed 1
Recruiting 1
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Clinical Trial Sponsors for Ridinilazole

Sponsor Name

Sponsor Name for
Sponsor Trials
Summit Therapeutics 4
Department of Health and Human Services 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 4
U.S. Fed 1
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