Product
Omadacycline
Aliases
Nuzyra, NUZYRA, Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet
Name
NUZYRA
INN Name
omadacycline
FDA Approved
Yes
9 clinical trials
1 organization
14 indications
1 document
Indication
Bacterial InfectionsIndication
Community-acquired PneumoniaIndication
PneumoniaIndication
Mycobacterial InfectionsIndication
NontuberculousIndication
Mycobacterium abscessus infectionIndication
Community-acquired Bacterial PneumoniaIndication
Cystic FibrosisIndication
Healthy Control ParticipantsIndication
Diabetic Foot InfectionIndication
Microbial ColonizationIndication
Healthy VolunteerClinical trial
A Ph. 2, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, & Tolerability of Oral Omadacycline in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus ComplexStatus: Active (not recruiting), Estimated PCD: 2024-06-01
Clinical trial
A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial InfectionsStatus: Recruiting, Estimated PCD: 2024-09-01
Clinical trial
A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)Status: Active (not recruiting), Estimated PCD: 2024-04-01
Clinical trial
A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-acquired Bacterial Pneumonia (CABP)Status: Recruiting, Estimated PCD: 2025-01-01
Clinical trial
Pharmacokinetics of Omadacycline in Patients With Cystic FibrosisStatus: Completed, Estimated PCD: 2023-12-01
Clinical trial
Microbiome Effect of Omadacycline on Healthy VolunteersStatus: Completed, Estimated PCD: 2023-09-01
Clinical trial
Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute OsteomyelitisStatus: Recruiting, Estimated PCD: 2023-08-18
Clinical trial
Effects of IV Omadacycline on Gut MicrobiomeStatus: Recruiting, Estimated PCD: 2024-10-01
Clinical trial
A Phase 1, Randomized, Double-Blind Study to Compare the Effect of Omadacycline PO Versus Moxifloxacin PO on the Gut Microbiota in Healthy Adult VolunteersStatus: Recruiting, Estimated PCD: 2024-07-30
Document
DailyMed Label: NUZYRAOrganization
Paratek Pharmaceuticals, Inc.