Omadacycline

Generic Name
Omadacycline
Brand Names
Nuzyra
Drug Type
Small Molecule
Chemical Formula
C29H40N4O7
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 prob...

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)
Associated Therapies
-

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

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

First Posted Date
2023-09-08
Last Posted Date
2023-09-08
Lead Sponsor
University of Houston
Target Recruit Count
32
Registration Number
NCT06030219
Locations
🇺🇸

University of Houston, Houston, Texas, United States

Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

First Posted Date
2021-03-03
Last Posted Date
2024-08-22
Lead Sponsor
Paratek Pharmaceuticals Inc
Target Recruit Count
670
Registration Number
NCT04779242
Locations
🇭🇺

Site 803, Debrecen, Hungary

🇧🇬

Site 212, Vidin, Bulgaria

🇧🇬

Site 206, Ruse, Bulgaria

and more 52 locations

Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

Recruiting
Conditions
Interventions
First Posted Date
2021-01-19
Last Posted Date
2024-11-20
Lead Sponsor
Methodist Health System
Target Recruit Count
600
Registration Number
NCT04714411
Locations
🇺🇸

Methodist Dallas Medical Center, Dallas, Texas, United States

🇺🇸

Methodist Charlton Medical Center, Dallas, Texas, United States

Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-11-12
Last Posted Date
2021-11-03
Lead Sponsor
Paratek Pharmaceuticals Inc
Target Recruit Count
18
Registration Number
NCT04160260
Locations
🇺🇸

Site 106, Doral, Florida, United States

🇺🇸

Site 102, San Diego, California, United States

🇺🇸

Site 104, San Diego, California, United States

and more 10 locations

Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

First Posted Date
2019-10-30
Last Posted Date
2021-08-25
Lead Sponsor
Hartford Hospital
Target Recruit Count
14
Registration Number
NCT04144374
Locations
🇺🇸

Hartford Hospital, Hartford, Connecticut, United States

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-11-28
Last Posted Date
2020-07-07
Lead Sponsor
Paratek Pharmaceuticals Inc
Target Recruit Count
201
Registration Number
NCT03757234
Locations
🇬🇪

Site 204, Tbilisi, Georgia

🇱🇻

Site 305, Rēzekne, Latvia

🇱🇻

Site 304, Liepāja, Latvia

and more 28 locations

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

First Posted Date
2016-08-24
Last Posted Date
2018-11-30
Lead Sponsor
Paratek Pharmaceuticals Inc
Target Recruit Count
735
Registration Number
NCT02877927
Locations
🇺🇸

Site 620, Birmingham, Alabama, United States

🇺🇸

Site 606, Buena Park, California, United States

🇺🇸

Site 604, Chula Vista, California, United States

and more 47 locations

Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

First Posted Date
2015-08-24
Last Posted Date
2019-01-16
Lead Sponsor
Paratek Pharmaceuticals Inc
Target Recruit Count
774
Registration Number
NCT02531438
Locations
🇵🇪

Site 481, Lima, Peru

🇨🇿

Site 411, Praha 10, Czechia

🇧🇬

Site 303, Pernik, Bulgaria

and more 137 locations

Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

First Posted Date
2015-03-04
Last Posted Date
2019-03-21
Lead Sponsor
Paratek Pharmaceuticals Inc
Target Recruit Count
655
Registration Number
NCT02378480
Locations
🇺🇸

Site 256, Augusta, Georgia, United States

🇺🇸

Site 252, Santa Ana, California, United States

🇺🇸

Site 259, Miami, Florida, United States

and more 75 locations
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