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Nacubactam - Fedora Pharmaceuticals/Meiji Seika Pharma

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Drug Profile

Nacubactam - Fedora Pharmaceuticals/Meiji Seika Pharma

Alternative Names: FPI 1459; OP 0595; RG 6080; RO 7079901

Latest Information Update: 08 Apr 2025

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At a glance

  • Originator Fedora Pharmaceuticals; Meiji Seika Pharma
  • Developer Meiji Seika Pharma
  • Class Anti-inflammatories; Antibacterials; Azabicyclo compounds; Small molecules; Urinary anti-infective agents
  • Mechanism of Action Beta lactamase 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 Bacterial infections; Pyelonephritis; Urinary tract infections

Most Recent Events

  • 14 Mar 2025 Adverse events and efficacy data from a phase III trial in Pyelonephritis, Urinary tract infections released by Meiji Seika Pharma
  • 26 Nov 2024 Meiji Seika Pharma completes a phase III trial in Pyelonephritis, Urinary tract infections (Combination therapy) in Lithuania, Estonia, Latvia, Bulgaria, Czech republic and Slovakia (IV) (NCT05887908)
  • 27 Apr 2024 Pharmacodynamics data from a preclinical trial inUrinary tract infections presented at the 34th Congress of the European Society of Clinical Microbiology and Infectious (ESCMID-2024)

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