Omadacycline

Generic Name: Omadacycline

Brand Names: Nuzyra

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₄₀N_₄O_₇

CAS Number: 389139-89-3

Unique Ingredient Identifier: 090IP5RV8F

Background: Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and Soft Tissue Infections. Omadacycline represents a significant advance over the well-known tetracycline family, and has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), and by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in both the hospital and community settings.

Indication: Omadacycline is indicated for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections caused by omadacycline-susceptible organisms in adults.

Associated Conditions: Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP)

Clinical Trials

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

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Moxifloxacin Oral Tablet
Drug: Omadacycline Oral Tablet

First Posted Date: 2024-06-17

Last Posted Date: 2024-11-01

Lead Sponsor: Zai Lab (Hong Kong), Ltd.

Target Recruit Count: 24

Registration Number: NCT06462326

Locations: 🇨🇳
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China

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

Phase 3

Recruiting

Conditions: Community-acquired Bacterial Pneumonia

Interventions: Drug: Moxifloxacin
Drug: Omadacycline

First Posted Date: 2023-12-08

Last Posted Date: 2024-06-14

Lead Sponsor: Zai Lab (Hong Kong), Ltd.

Target Recruit Count: 100

Registration Number: NCT06162286

Locations: 🇨🇳
The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department, Changsha, China
🇨🇳
Kunming First People's Hospital/Respiratory Medicine, Kunming, China
🇨🇳
Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department, Shanghai, China

and more 37 locations

Microbiome Effect of Omadacycline on Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Vancomycin Pill
Drug: Omadacycline
Drug: Moxifloxacin

First Posted Date: 2023-09-08

Last Posted Date: 2025-03-25

Lead Sponsor: University of Houston

Target Recruit Count: 32

Registration Number: NCT06030219

Locations: 🇺🇸
University of Houston, Houston, Texas, United States

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

Phase 2

Recruiting

Conditions: Bone Infection
Joint Infection
Bone and Joint Infection

Interventions: Drug: Omadacycline Pill
Drug: Standard of Care

First Posted Date: 2023-03-03

Last Posted Date: 2025-03-10

Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Target Recruit Count: 180

Registration Number: NCT05753215

Locations: 🇺🇸
The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States

Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Phase 4

Completed

Conditions: Microbial Colonization

Interventions: Drug: Omadacycline Injection

First Posted Date: 2022-08-25

Last Posted Date: 2025-03-17

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 8

Registration Number: NCT05515562

Locations: 🇺🇸
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

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

Phase 1

Recruiting

Conditions: Bacterial Infections

Interventions: Drug: Omadacycline Injection [Nuzyra]
Drug: Omadacycline Oral Tablet

First Posted Date: 2022-02-01

Last Posted Date: 2024-08-22

Lead Sponsor: Paratek Pharmaceuticals Inc

Target Recruit Count: 40

Registration Number: NCT05217537

Locations: 🇺🇸
Site 109, Little Rock, Arkansas, United States
🇺🇸
Site 108, Houston, Texas, United States
🇺🇸
Site 107, Orange, California, United States

and more 6 locations

Oral Omadacycline Vs. Placebo in Adults with NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

Phase 2

Completed

Conditions: Mycobacterium Infections, Nontuberculous
Nontuberculous Mycobacterial Pulmonary Infection
Mycobacterium Abscessus Infection
Nontuberculous Mycobacterial Lung Disease

Interventions: Drug: Placebo
Drug: Omadacycline Oral Tablet

First Posted Date: 2021-06-10

Last Posted Date: 2024-10-03

Lead Sponsor: Paratek Pharmaceuticals Inc

Target Recruit Count: 66

Registration Number: NCT04922554

Locations: 🇺🇸
Stanford University, Stanford, California, United States
🇺🇸
Georgetown University Hospital, Washington, District of Columbia, United States
🇺🇸
St. Francis Medical Institute, Clearwater, Florida, United States

and more 14 locations