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Tebipenem pivoxil - Spero Therapeutics

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Drug Profile

Tebipenem pivoxil - Spero Therapeutics

Alternative Names: GSK-3778712; L-084; ME1211; Orapenem; SPR-994; TBP-PI-HBr; TBPM-PI-HBr; Tebipenem; Tebipenem HBr; Tebipenem pivoxil hydrobromide; Tebipenem-prodrug

Latest Information Update: 25 Aug 2025

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At a glance

  • Originator Wyeth K.K.
  • Developer GSK; Meiji Seika Pharma; Spero Therapeutics; Wyeth K.K.
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Azabicyclo compounds; Azetidines; Carbapenems; Esters; Small molecules; Thiazoles; Urinary anti-infective agents
  • 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

  • Marketed Haemophilus infections; Streptococcal infections
  • Preregistration Pyelonephritis; Urinary tract infections
  • Phase II Shigella infections
  • No development reported Unspecified

Most Recent Events

  • 12 Aug 2025 GSK announces intention to submit regulatory filings for Urinary tract infections in second half of 2025
  • 06 Jun 2025 Spero Therapeutics terminates a phase-III clinical trials in Pyelonephritis in US, Bosnia-Herzegovina, Bulgaria, Croatia, Estonia, Georgia, Hungary, Moldova, Poland, Romania, Serbia, Slovakia, South Africa, Argentina, Brazil, Greece, India, Latvia and Turkey following recommendation from an Independent Data Monitoring Committee (PO) (NCT06059846)
  • 22 Apr 2025 Spero Therapeutics completes a phase I pharmacokinetics trial in healthy volunteers in USA (PO, tablet) (NCT06727136)

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