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Wainwright & Co"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Sulopenem","moa":"Cell wall","graph1":"Infections and Infectious Diseases","graph2":"Phase III","graph3":"Iterum Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Oral","sponsorNew":"Iterum Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Iterum Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Sulopenem Etzadroxil","moa":"Cell wall","graph1":"Infections and Infectious Diseases","graph2":"Phase III","graph3":"Iterum Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Oral","sponsorNew":"Iterum Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Iterum Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Sulopenem Etzadroxil","moa":"Cell wall","graph1":"Infections and Infectious Diseases","graph2":"Phase III","graph3":"Iterum Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Oral","sponsorNew":"Iterum Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Iterum Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Small molecule","year":"2020","type":"Public Offering","leadProduct":"Sulopenem Etzadroxil","moa":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III","graph3":"Iterum Therapeutics","amount2":0.02,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Infectious Diseases","amount2New":0.02,"dosageForm":"Oral","sponsorNew":"Iterum Therapeutics \/ H.C. Wainwright & Co.","highestDevelopmentStatusID":"10","companyTruncated":"Iterum Therapeutics \/ H.C. Wainwright & Co."},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"H.C. Wainwright & Co","pharmaFlowCategory":"D","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Small molecule","year":"2021","type":"Public Offering","leadProduct":"Sulopenem Etzadroxil","moa":"Cell wall","graph1":"Infections and Infectious Diseases","graph2":"Phase III","graph3":"Iterum Therapeutics","amount2":0.040000000000000001,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Infectious Diseases","amount2New":0.01,"dosageForm":"Tablet","sponsorNew":"Iterum Therapeutics \/ H.C. Wainwright & Co","highestDevelopmentStatusID":"10","companyTruncated":"Iterum Therapeutics \/ H.C. 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Find Clinical Drug Pipeline Developments & Deals by Iterum Therapeutics

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                          01

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          02

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          03

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          04

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          05

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          06

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          07

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          08

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          09

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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

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                          10

                          PackExpo
                          Not Confirmed
                          PackExpo
                          Not Confirmed

                          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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