Solithromycin - Melinta Therapeutics

Drug Profile

Solithromycin - Melinta Therapeutics

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

Latest Information Update: 28 Jun 2018

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At a glance

  • Originator Optimer Pharmaceuticals
  • Developer Cempra Pharmaceuticals; Melinta Therapeutics; 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; Sinusitis; Urethritis
  • Phase II Chronic obstructive pulmonary disease; Non-alcoholic steatohepatitis
  • Preclinical Eye-Disorders
  • No development reported Anthrax; Bacterial infections; Cystic fibrosis; Enterococcal infections; Legionella infections; Malaria; Mycobacterium avium complex infections; Mycoplasma infections; Obstetric and gynaecological infections; Otitis media; Tularaemia

Most Recent Events

  • 28 Jun 2018 No recent reports of development identified for preclinical development in Otitis-media in USA
  • 24 Jun 2018 Biomarkers information updated
  • 29 May 2018 Cempra terminates a phase II/III trial due to development not proceeding in Community-acquired pneumonia (In adolescents, In children, In infants) in USA, United Kingdom, Philippines, Bulgaria, Spain, Hungary (IV) (NCT02605122)
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