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Sulopenem - Iterum Therapeutics

Drug Profile

Sulopenem - Iterum Therapeutics

Alternative Names: CP-70,429

Latest Information Update: 29 Nov 2019

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At a glance

  • Originator Pfizer
  • Developer Iterum Therapeutics; Pfizer
  • Class Antibacterials; Aza compounds; Beta-lactams; Esters; Penems; Small molecules
  • Mechanism of Action Cell wall inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Intra-abdominal infections; Urinary tract infections
  • Discontinued Bacterial infections; Community-acquired pneumonia

Most Recent Events

  • 18 Nov 2019 Iterum Therapeutics completes enrolment in the phase III SURE 2 trial for Urinary tract infections (Complicated) in Estonia, Georgia, Hungary, Latvia and USA (NCT03357614)
  • 02 Oct 2019 Iterum Therapeutics completes a phase III trial in Intra-abdominal infections (complicated) in USA, Poland, Latvia, Hungary, Georgia, Estonia, Bulgaria (IV) (NCT03358576)
  • 14 Aug 2019 Iterum Therapeutics announces intention to submit NDA to US FDA for Intra-abdominal infections and Urinary tract infections in the first half of 2020
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