Overview
Omadacycline is a once-daily oral and intravenous broad-spectrum antibiotic in a new class of tetracycline derivatives known as aminomethylcyclines. In 2017, Zai obtained an exclusive license to develop, manufacture, and commercialize omadacycline in greater China from Paratek Pharmaceuticals. Omadacycline has been designed to address tetracycline resistance and has been developed for acute bacterial skin/skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Three pivotal Phase 3 studies of omadacycline in ABSSSI and CABP have achieved their respective primary endpoints. Omadacycline has been granted Qualified Infectious Disease Product (QIDP) status in the United States and Fast Track status by the FDA. On October 2, 2018, omadacycline was approved for the treatment of adults with CABP and ABSSSI by FDA. In December 2021, China NMPA approves NUZYRA® as a category 1 innovative drug for the treatment of adult patients with CABP and ABSSSI.
Mechanism of Action
Antibiotic resistance has become a significant public health challenge, and there is an increasing need for effective, well-tolerated antibiotics. Omadacycline has been designed to overcome the two major mechanisms of tetracycline resistance—pump efflux and ribosome protection. Omadacycline has demonstrated in vitro activity against all common pathogens found in ABSSSI, such as Staphylococcus aureus (including methicillin-resistant Staphylococcus aureus, or MRSA), Streptococci (including Group A Streptococci), anaerobic pathogens and many Gram-negative organisms. Omadacycline is also active in vitro against the key pathogens found in CABP, such as Streptococcus pneumoniae, including multi-drug-resistant Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae and atypical bacteria, including Legionella pneumophila.