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Omadacycline - Paratek Pharmaceuticals

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Drug Profile

Omadacycline - Paratek Pharmaceuticals

Alternative Names: Amadacycline; BAY 73-6944; BAY 73-7388; MK-2764; Neopentyl aminomethylminocycline; NUZYRA; PTK-0796; ZL 2401

Latest Information Update: 12 Mar 2024

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At a glance

  • Originator Tufts University
  • Developer Merck & Co; Paratek Pharmaceuticals; ZAI Lab
  • Class Anti-infectives; Anti-inflammatories; Antibacterials; Small molecules; Tetracyclines
  • Mechanism of Action Protein synthesis inhibitors
  • Orphan Drug Status

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

    Yes - Nontuberculous mycobacterium infections
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Community-acquired pneumonia; Skin and soft tissue infections
  • Preregistration Anthrax
  • Phase II Cystitis; Nontuberculous mycobacterium infections; Pyelonephritis; Urinary tract infections
  • Phase I Bacterial infections
  • No development reported Acute sinusitis; Plague
  • Discontinued Nosocomial infections

Most Recent Events

  • 05 Mar 2024 Preclinical trials in Anthrax in USA (Inhalation) prior to March 2024
  • 05 Mar 2024 Paratek Pharmaceuticals plans a meeting with US FDA to align on the final studies required to support the sNDA submission for both anthrax treatment and PEP indications in the middle of 2024
  • 05 Mar 2024 Paratek Pharmaceuticals plans to file sNDA to US FDA for Anthrax and post-exposure prophylaxis (PEP)
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