A phase II study was conducted comparing the safety and efficacy of<unk>  to linezolid for the treatment of complicated skin and skin structure infections. Patients were randomized at 11 sites in the US to receive either<unk>  100 mg intravenously once daily with an option to transition to 200 mg orally once daily or linezolid 600 mg intravenously twice daily with an option to transition to 600 mg orally twice daily. The results indicated that<unk>  is well tolerated and has the potential to be an effective treatment in patients with complicated skin and skin structure infections. In June 2013, the US Food and Drug Administration (FDA) designated the intravenous and oral formulations of<unk>  as a qualified infectious disease product in the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. A 650-patient phase III registration study comparing<unk>  to linezolid for the treatment of acute bacterial skin and skin structure infections began in June 2015.<unk>  met the primary efficacy endpoint of early clinical response with statistical non-inferiority (10% margin) compared to linezolid, and was generally safe and well tolerated. The most common treatment-emergent adverse events were gastrointestinal side effects (18.0% for<unk>  vs. 15.8% for linezolid). A 750-patient phase III study comparing<unk>  to moxifloxacin for the treatment of community-acquired bacterial pneumonia began in November 2015.<unk>  was statistically non-inferior to moxifloxacin at the early clinical response, 72 to 120 hours after therapy was initiated. In May 2016, a phase Ib study of<unk>  in urinary tract infection was initiated. In August 2016, a second phase III study of<unk>  was initiated in patients with acute bacterial skin and skin structure infections, comparing the efficacy and safety of once-daily, oral<unk>  to that of twice-daily, oral linezolid. In July 2017, analysis of the data showed that all of the primary and secondary endpoints required for submission to the FDA and EMA were met. This was the third phase 3 registration study of<unk>  with favorable results.
Omadacycline
Sarecycline
Eravacycline
Oxytetracycline
Daptomycin
Doxycycline
Teicoplanin
Minocycline