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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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2024
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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct 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 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 infections (uUTI).
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2020
Details:
The results of this new study complement previous preclinical data demonstrating the combination's potential to substantially increase the brain concentration of AV-101's active metabolite, 7-Cl-KYN, thereby reducing, rather than blocking, NMDA receptor signaling.
Lead Product(s): 4-Chlorokynurenine,Probenecid
Therapeutic Area: Neurology Product Name: AV-101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 clinical trial in complicated urinary tract infection (cUTI).
Lead Product(s): Sulopenem,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
Under this agreement, VistaGen and Nuformix initially will apply Nuformix's proprietary technology platform to develop patentable new crystalline forms of AV-101 that may have superior delivery, an enhanced therapeutic profile and additional intellectual property protection.
Lead Product(s): 4-Chlorokynurenine,Probenecid
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: VistaGen Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 27, 2020
Details:
Company anticipates reporting results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial in uUTI and SURE 2 clinical trial in cUTI in early part of the 2nd quarter of 2020.
Lead Product(s): Sulopenem,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
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