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Tebipenem pivoxil - Spero Therapeutics

Drug Profile

Tebipenem pivoxil - Spero Therapeutics

Alternative Names: L-084; ME1211; Orapenem; SPR-994; TBPM-PI-HBr; Tebipenem; Tebipenem pivoxil hydrobromide; Tebipenem-prodrug

Latest Information Update: 06 Feb 2019

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At a glance

  • Originator Wyeth K.K.
  • Developer Meiji Seika Pharma; Spero Therapeutics
  • Class Antibacterials; Carbapenems; Esters; Small molecules; Thiazoles
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Haemophilus infections; Streptococcal infections
  • Phase I Urinary tract infections
  • Preclinical Gram-negative infections

Most Recent Events

  • 04 Feb 2019 The US FDA approves IND application for tebipenem pivoxil in Urinary tract infections
  • 07 Jan 2019 Spero Therapeutics files an IND application with the US FDA for the phase III ADAP-PO trial in Urinary tract infections
  • 07 Jan 2019 Spero Therapeutics plans to initiate the pivotal phase III ADAPT-PO trial in Urinary tract infections in USA (PO), to support an NDA, in the first quarter of 2019 (NCT03788967)
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