X
[{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO\u2122 (fosfomycin) for injection","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Nabriva Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Provides Update on Phase 3 Clinical Trials of Sulopenem","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"H.C. Wainwright & Co","pharmaFlowCategory":"D","amount":"$5.0 million","upfrontCash":"Undisclosed","newsHeadline":"Iterum Therapeutics Announces $5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum's Future Looks Uncertain, After Lead Antibiotic Fails Consecutive Pivotal Studies","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics to Present Data from Phase 3 Trials in Uncomplicated and Complicated Urinary Tract Infections at IDWeek 2020","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$17.5 million","upfrontCash":"Undisclosed","newsHeadline":"Iterum Therapeutics Announces Pricing of $17.5 Million Upsized Public Offering","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"H.C. Wainwright & Co","pharmaFlowCategory":"D","amount":"$35.0 million","upfrontCash":"Undisclosed","newsHeadline":"Iterum Therapeutics plc Announces $35.0 Million Registered Direct Offering of Ordinary Shares Priced At-the-Market under Nasdaq Rules","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Provides Update on NDA Review","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Presented Data at the 32nd European Congress of Clinical Microbiology and Infectious Diseases","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"U.S. Food and Drug Administration","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Iterum Therapeutics","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Iterum Therapeutics"},{"orgOrder":0,"company":"Icon Plc","sponsor":"BARDA","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ICON Selected By BARDA To Conduct Anthrax Vaccine Clinical Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Vaccine","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Vaccine","graph2":"Icon Plc"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Filters
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.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: PF-03709270
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Pfizer Inc
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 30, 2024
Details:
This clinical study will inform operational logistics and will not expose participants to anthrax. AV7909 is indicated for post-exposure prophylaxis of anthrax disease. Anthrax vaccine is also recommended for unvaccinated people of all ages who have been exposed to anthrax.
Lead Product(s):
AV7909
Therapeutic Area: Infections and Infectious Diseases
Product Name: AV7909
Highest Development Status: Phase III
Product Type: Vaccine
Partner/Sponsor/Collaborator:
BARDA
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 06, 2022
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 antibiotics.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 19, 2022
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 urinary tract infections.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
U.S. Food and Drug Administration
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Agreement
July 11, 2022
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 antibiotics.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Sulopenem
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 25, 2022
Details:
Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 28, 2021
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-susceptible pathogen.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 27, 2021
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 oral sulopenem.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
H.C. Wainwright & Co
Deal Size: $35.0 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
February 09, 2021
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.
Lead Product(s):
Sulopenem Etzadroxil ,Probenecid
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 25, 2021
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 development of sulopenem.
Lead Product(s):
Sulopenem Etzadroxil
Therapeutic Area: Infections and Infectious Diseases
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
H.C. Wainwright & Co.
Deal Size: $17.5 million
Upfront Cash: Undisclosed
Deal Type: Public Offering
October 23, 2020