Drug Profile


Alternative Names: CEM-101; OP-1068; T-4288

Latest Information Update: 07 Feb 2017

Price : $50

At a glance

  • Originator Optimer Pharmaceuticals
  • Developer Cempra Pharmaceuticals; Toyama Chemical
  • Class Antibacterials; Antimalarials; Heterocyclic bicyclo compounds; Ketolides; Macrolides; Oxazoles; Pyrans; Small molecules
  • Mechanism of Action Protein 50S ribosomal subunit inhibitors
  • Orphan Drug Status

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

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Community-acquired pneumonia
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Community-acquired pneumonia
  • Phase III Bronchitis; Chlamydial infections; Gonorrhoea; Otorhinolaryngological infections; Respiratory tract infections; Urethritis
  • Phase II Chronic obstructive pulmonary disease; Non-alcoholic steatohepatitis
  • Phase I Anthrax; Bacterial infections; Tularaemia
  • Preclinical Cystic fibrosis; Obstetric and gynaecological infections; Otitis media
  • Research Enterococcal infections; Legionella infections; Mycoplasma infections
  • No development reported Malaria; Mycobacterium avium complex infections

Most Recent Events

  • 13 Jan 2017 Cempra Pharmaceuticals in collaboration with National Institute of Allergy and Infectious Diseases completes a phase I trial in Gonorrhoea (In volunteers) in USA (NCT02348424)
  • 11 Jan 2017 Toyoma completes a phase I bioavailability trial in Healthy volunteers in Japan (PO) (JapicCTI153006)
  • 11 Jan 2017 Toyama completes a phase II trial in Otorhinolaryngological infections in Japan (PO) before December 2014 (JapicCTI-142754)
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