![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
SMT19969 (ridinilazole) is a targeted-spectrum antimicrobial that shows potential in treatment of initial C difficile infection and in providing sustained benefit through reduction in disease recurrence.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
Ridinilazole is the investigational first-in-class drug that completed enrollment of a Phase III clinical trial, Ri-CoDIFy. The primary endpoint of this trial seeks to demonstrate the superiority of ridinilazole in sustained clinical response as compared to vancomycin.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
Ridinilazole is our investigational drug currently in Phase III Ri-CoDIFy clinical trials with the goal of use as first-line therapy to treat initial infection and reduce recurrence of Clostridioides difficile infection.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2021
Details:
Funds to be used for continued patient enrolment into the Ri-CoDIFy Phase 3 clinical trial program of ridinilazole; Preparatory activities to support the commercial launch of ridinilazole; Development of early-stage research projects using Discuva Platform.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Polar Capital
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement November 06, 2020
Details:
Funds support continued patient enrolment into the Ri-CoDIFy Phase 3 clinical trial program of ridinilazole for the treatment of Clostridium difficile infection; launch of Ridinilazole and Development of early-stage research projects using the Company’s Discuva Platform.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 02, 2020
Details:
The data demonstrated that ridinilazole’s microbiome preservation resulted in a gut environment expected to inhibit the growth of C. difficile. In contrast, vancomycin treatment resulted in a gut environment that may more highly favor the growth of C. difficile.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: SMT19969
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2020
Details:
The milestone payment was initiated by Summit achieving its initial patient enrolment target at trial sites in Latin America in the Phase 3 clinical trials of ridinilazole for C. difficile infection.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eurofarma Laboratorios S.A
Deal Size: $3.8 million Upfront Cash: Undisclosed
Deal Type: Collaboration February 06, 2020
Details:
The additional funding is being provided to support a new clinical trial in adolescent patients and brings the total value of the award to up to $72.5 million.
Lead Product(s): Ridinilazole
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biomedical Advanced Research and Development Authority
Deal Size: $72.5 million Upfront Cash: Undisclosed
Deal Type: Funding January 23, 2020