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Omadacycline Oral Tablet

DRUG4 trials

Sponsors

Paratek Pharmaceuticals Inc, Zai Lab (Hong Kong), Ltd., Vancouver Coastal Health

Conditions

Bacterial InfectionsHealthy VolunteerMycobacterium Abscessus InfectionMycobacterium Infections, NontuberculousNon-Tuberculous Mycobacterial (NTM) PneumoniaNontuberculous Mycobacterial Lung DiseaseNontuberculous Mycobacterial Pulmonary Infection

Phase 1

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
CompletedNCT05217537
Paratek Pharmaceuticals IncBacterial Infections
Start: 2022-04-06End: 2025-02-27Updated: 2026-03-09
A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
CompletedNCT06462326
Zai Lab (Hong Kong), Ltd.Healthy Volunteer
Start: 2024-04-16End: 2024-09-29Updated: 2024-11-01
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
Enrolling by invitationNCT07228702
Vancouver Coastal HealthMycobacterium Abscessus Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
Start: 2026-01-11End: 2027-10-01Target: 1Updated: 2026-06-03

Phase 2

Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
CompletedNCT04922554
Paratek Pharmaceuticals IncMycobacterium Abscessus Infection, Mycobacterium Infections, Nontuberculous, Nontuberculous Mycobacterial Lung Disease +1
Start: 2021-10-15End: 2024-07-17Updated: 2025-07-30

Related Papers

336. Microbiological Outcomes of Oral Omadacycline Treatment in Adults with Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) Caused by Mycobacterium abscessus complex (MABc): Results from a Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Trial
Open Forum Infectious Diseases2026-01-01
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Omadacycline in Adults With Nontuberculous Mycobacterial Pulmonary Disease (NTM PD) Caused by Mycobacterium Abscessus Complex (MABc)
American Journal of Respiratory and Critical Care Medicine2025-05-012 citations
Evaluation of omadacycline against intracellular <i>Mycobacterium abscessus</i> in an infection model in human macrophages
JAC-Antimicrobial Resistance2023-09-045 citations