Overview
Eravacycline, known as Xerava by Tetraphase Pharmaceuticals, is a fully synthetic fluorocycline antibiotic of the tetracycline class with activity against clinically significant gram-negative, gram-positive aerobic, and facultative bacteria. This includes most of those bacteria resistant to cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, multidrug-resistant strains, and carbapenem-resistant Enterobacteriaceae, and the majority of anaerobic pathogens . It was first approved by the FDA on August 27, 2018 . Eravacycline has demonstrated superior potency to that of antibiotics that are currently being marketed for intraabdominal infections .
Background
Eravacycline, known as Xerava by Tetraphase Pharmaceuticals, is a fully synthetic fluorocycline antibiotic of the tetracycline class with activity against clinically significant gram-negative, gram-positive aerobic, and facultative bacteria. This includes most of those bacteria resistant to cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, multidrug-resistant strains, and carbapenem-resistant Enterobacteriaceae, and the majority of anaerobic pathogens . It was first approved by the FDA on August 27, 2018 . Eravacycline has demonstrated superior potency to that of antibiotics that are currently being marketed for intraabdominal infections .
Indication
Eravacycline is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older .
Associated Conditions
- Intraabdominal Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/01 | N/A | Not yet recruiting | |||
2024/06/03 | Phase 4 | Recruiting | Clinical Hospital Centre Zagreb | ||
2024/02/28 | N/A | Recruiting | |||
2024/01/25 | N/A | Not yet recruiting | Sichuan Provincial People's Hospital | ||
2022/09/13 | Phase 2 | Recruiting | |||
2018/10/04 | Phase 1 | Completed | |||
2017/01/26 | Phase 3 | Completed | |||
2016/05/27 | Phase 3 | Completed | |||
2014/05/09 | Phase 1 | Completed | |||
2014/05/09 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/20/2018 | ||
Authorised | 9/20/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| XERAVA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG PER VIAL | SIN15930P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50mg/vial | 4/15/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Eravacycline Hydrochloride for Injection | 国药准字HJ20233135 | 化学药品 | 注射剂 | 3/15/2023 |
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. | |||||