Overview
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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/17 | Phase 1 | Completed | |||
2023/12/08 | Phase 3 | Recruiting | |||
2023/09/08 | Phase 1 | Completed | |||
2023/03/03 | Phase 2 | Recruiting | |||
2022/08/25 | Phase 4 | Completed | |||
2022/02/01 | Phase 1 | Recruiting | |||
2021/06/10 | Phase 2 | Completed | |||
2021/03/03 | Phase 3 | Completed | |||
2021/01/19 | N/A | Recruiting | |||
2020/07/07 | Phase 4 | Completed | Paul Beringer |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Paratek Pharmaceuticals, Inc. | 71715-001 | INTRAVENOUS | 100 mg in 5 mL | 5/31/2021 | |
| Paratek Pharmaceuticals, Inc. | 71715-002 | ORAL | 150 mg in 1 1 | 5/31/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Omadacycline Tosilate for Injection | 国药准字H20210050 | 化学药品 | 注射剂 | 12/14/2021 | |
| Omadacycline Tosilate Tablets | 国药准字H20210049 | 化学药品 | 片剂 | 12/14/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||