As of July 2012[update], tedizolid had completed one phase III trial, with another one under way. Both trials compare a six-day regimen of tedizolid 200 mg once-daily against a ten-day regimen of linezolid 600 mg twice-daily. The results of the pivotal phase III trial ESTABLISH 1 were published in February 2013. It met the primary and both secondary endpoints.
Tedizolid has been approved by the FDA on June 20, 2014 for the treatment of methicillin-resistant S. aureus skin infections. It can be taken both orally and given via IV injection. Sivextro is the second treatment approved by the Food and Drug Administration under the new federal Generating Antibiotic Incentives Now law, known as the GAIN Act. That law gives drug makers priority review and an additional five years of market exclusivity in order to spur the development of new antibiotics to fight the rise of drug-resistant “superbugs.”