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
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : H.C. Wainwright & Co.
Deal Size : $17.5 million
Deal Type : Public Offering
Iterum Therapeutics Announces Pricing of $17.5 Million Upsized Public Offering
Details : The Company intends to use the net proceeds from this offering to support its planned NDA submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical dev...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 23, 2020
Lead Product(s) : Sulopenem Etzadroxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : H.C. Wainwright & Co.
Deal Size : $17.5 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
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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