NUZYRA

PeakSM

omadacycline

NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16

Mechanism of Action

12.1 Mechanism of Action NUZYRA is an antibacterial drug [see ]. 12.2 Pharmacodynamics Cardiac Electrophysiology Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically…

Pharmacologic Class:

Tetracycline-class Antibacterial

Clinical Trials (5)

NCT06462326Phase 1Completed

A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

Started Apr 2024
24 enrolled
Healthy Volunteer
NCT06162286Phase 3Recruiting

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

Started Nov 2023
100 enrolled
Community-acquired Bacterial Pneumonia
NCT05753215Phase 2Active Not Recruiting

Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection

Started May 2023
NCT05515562Phase 4Completed

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Started Mar 2023
NCT05217537Phase 1Completed

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

Started Apr 2022
23 enrolled
Bacterial Infections

Loss of Exclusivity

LOE Date
Oct 31, 2037
142 months away
Patent Expiry
Oct 31, 2037
Exclusivity Expiry
Oct 2, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
9724358
Mar 5, 2029
U-1569
10124014
Mar 5, 2029
U-2449
8383610
Sep 23, 2030
Substance
9265740
Oct 24, 2030
Product
U-1569
9314475
Mar 18, 2031
Product