Omadacycline

Drug Profile

Omadacycline

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

Latest Information Update: 10 Oct 2017

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At a glance

  • Originator Paratek Pharmaceuticals
  • Developer Merck & Co; Paratek Pharmaceuticals
  • Class 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Community-acquired pneumonia; Skin and soft tissue infections
  • Phase I Nosocomial infections; Urinary tract infections
  • Preclinical Acute sinusitis; Respiratory tract infections
  • Research Anthrax; Plague

Most Recent Events

  • 06 Oct 2017 Efficacy and safety data from three sub-analyses of the phase III OASIS-1 trial in Skin and soft tissue infections released by Paratek Pharmaceuticals
  • 21 Sep 2017 Omadacycline receives Qualified Infectious Disease Product status for uncomplicated Urinary tract infections in USA
  • 02 Aug 2017 Paratek Pharmaceuticals intends to initiate rolling submission in December 2017 based on pre-NDA meetings with the US FDA
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