Telavancin: the long and winding road from discovery to food and drug administration approvals and future directions.

Telavancin (TD-6424) was discovered in 2000 and became the first marketed semisynthetic lipoglycopeptide in 2009. This parenteral antibacterial agent has a dual mechanism of action and potent in vitro activity against gram-positive pathogens, including methicillin-resistant Staphylococcus aureus and isolates with reduced vancomycin susceptibility. Pharmacokinetic and pharmacodynamic analyses support the concentration-dependent activity and once-daily dosing regimen of telavancin. A changing regulatory approval process, manufacturing obstacles, and the termination of a commercialization partnership have challenged the development and marketing of telavancin. The commercial operations for telavancin have been restored, a new manufacturer has been secured, and reliable product supplies are available for clinical use. In addition, telavancin continues to be supported by ongoing clinical research with the recent launch of the Telavancin Observational Use Registry (TOUR; NCT02288234) in the United States and an international phase 3, randomized trial comparing telavancin with standard therapy for the treatment of patients with complicated S. aureus bacteremia, including endocarditis (NCT02208063).