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 FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 25, 2024
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
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 : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Probenecid
Therapeutic Area : Undisclosed
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 06, 2023
Lead Product(s) : Probenecid
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Probenecid
Therapeutic Area : Undisclosed
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Relative Bioavailability Study With a Novel PanCytoVirâ„¢ Oral Suspension (100 mg/ml)
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 06, 2023
Lead Product(s) : Probenecid
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : US Food & 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...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Undisclosed
November 07, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : US Food & 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 : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 19, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : PanCytoVir
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 05, 2022
Lead Product(s) : Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 25, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Probenecid
Therapeutic Area : Genetic Disease
Study Phase : Phase II
Sponsor : Otsuka Holdings
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 13, 2022
Lead Product(s) : Probenecid
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Sponsor : Otsuka Holdings
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 28, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable