Drug Profile


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

Latest Information Update: 19 Sep 2017

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At a glance

  • Originator Optimer Pharmaceuticals
  • Developer Cempra Pharmaceuticals; Toyama Chemical
  • Class Anti-infectives; 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.

  • 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; Eye disorders; Obstetric and gynaecological infections; Otitis media
  • Research Enterococcal infections; Legionella infections; Mycoplasma infections
  • No development reported Malaria; Mycobacterium avium complex infections

Most Recent Events

  • 09 Aug 2017 Cempra plans to file an IND application with the US FDA for Eye disorders in 2018
  • 10 May 2017 Preclinical trials in Eye disorders in USA (Ophthalmic)
  • 22 Apr 2017 Efficacy data from the phase III SOLITAIRE-Oral and SOLITAIRE-IV trials in Community-acquired pneumonia presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID-2017)
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