Overview
Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid. Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO®). This product is currently available as both an oral tablet and as a powder for intravenous injection.
Indication
用于特定的敏感细菌引起的成人急性细菌性皮肤和皮肤结构感染（ABSSSI）。抗菌谱为金黄色葡萄球菌(包括耐甲氧西林和甲氧西林敏感菌株)，化脓性链球菌，无乳链球菌，咽峡炎链球菌群(包括咽峡炎链球菌、中间型链球菌、星群链球菌)，粪肠球菌。
Associated Conditions
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/13 | Phase 1 | Completed | |||
2024/09/24 | Phase 1 | Completed | |||
2022/09/09 | Phase 2 | Recruiting | |||
2022/06/01 | Phase 4 | Recruiting | Fundacion Clinic per a la Recerca Biomédica | ||
2018/11/19 | Phase 4 | Completed | Fundacion Clinic per a la Recerca Biomédica | ||
2017/12/19 | Not Applicable | Completed | Tourcoing Hospital | ||
2017/07/14 | Phase 1 | Completed | |||
2017/06/05 | Phase 3 | Completed | |||
2017/01/04 | Phase 2 | Completed | |||
2016/12/13 | N/A | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Merck Sharp & Dohme LLC | 67919-041 | ORAL | 200 mg in 1 1 | 3/10/2023 | |
| Merck Sharp & Dohme LLC | 67919-040 | INTRAVENOUS | 200 mg in 4 mL | 3/10/2023 | |
| Nabriva Therapeutics US, Inc. | 72000-310 | ORAL | 200 mg in 1 1 | 7/25/2022 | |
| Nabriva Therapeutics US, Inc. | 72000-320 | INTRAVENOUS | 200 mg in 4 mL | 7/25/2022 |
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 |
|---|---|---|---|---|---|
| SIVEXTRO LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION 200MG PER VIAL | SIN14851P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200mg | 9/16/2015 | |
| SIVEXTRO FILM-COATED TABLET 200MG | SIN14850P | TABLET, FILM COATED | 200mg | 9/16/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
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