Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
US FDA Approves Iterum's Treatment for Urinary Infection
Details : Orlynvah (sulopenem etzadroxil & probenecid) is a combination product candidate, which is indicated for the treatment of uncomplicated urinary tract infections.
Brand Name : Orlynvah
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 25, 2024
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
Iterum Announces Positive Results From Phase 3 REASSURE Trial Of Oral Sulopenem In UTIs
Details : Oral Sulopenem (sulopenem etzadroxil/probenecid) is a cell wall inhibitor which is being evaluated in phase 3 clinical trials for the treatment of uncomplicated urinary tract infections & cystitis.
Brand Name : PF-03709270
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 30, 2024
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Iterum Therapeutics Announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
Details : Sulopenem Etzadroxil is a novel penem anti-infective compound, in Phase 3 clinical development. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibioti...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 19, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : U.S. Food and Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
Details : Food and Drug Administration under the special protocol assessment process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated ur...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 11, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : U.S. Food and Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibio...
Brand Name : Sulopenem
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 25, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem
Details : Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 28, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Iterum Therapeutics Provides Update on NDA Review
Details : During the meeting, the FDA shared issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susce...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 27, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : H.C. Wainwright & Co
Deal Size : $35.0 million
Deal Type : Public Offering
Details : The Company intends to use the net proceeds for the ongoing review of its NDA for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen, for pre-commercialization and potential launch activities for...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 09, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : H.C. Wainwright & Co
Deal Size : $35.0 million
Deal Type : Public Offering
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem
Details : Sulopenem is a novel penem anti-infective compound. The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 25, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The two data presentations will include a poster presentation of the results of SURE-2 in complicated urinary tract infections (cUTI) as well as a late breaker oral abstract presentation of the results from SURE-1 in uncomplicated urinary tract infection...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 19, 2020
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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