Tedizolid

Generic Name: Tedizolid

Brand Names: Sivextro

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₅FN_₆O_₃

CAS Number: 856866-72-3

Unique Ingredient Identifier: 97HLQ82NGL

Background: 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

A Phase 1, Open-Label, 10 Day Safety Study

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: TR-701 FA

First Posted Date: 2012-06-20

Last Posted Date: 2017-10-06

Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 72

Registration Number: NCT01623401

Locations: 🇺🇸
Trius Investigator Site 001, Dallas, Texas, United States

A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: TR-701 FA single infusion
Drug: TR-701 FA

First Posted Date: 2011-10-17

Last Posted Date: 2016-05-03

Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 24

Registration Number: NCT01452828

Locations: 🇺🇸
Trius Investigator Site 001, Orlando, Florida, United States
🇺🇸
Trius Investigator Site 002, Minneapolis, Minnesota, United States

A PK and Safety Study in Subjects With Hepatic Impairment

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: TR-701 FA

First Posted Date: 2011-09-12

Last Posted Date: 2016-05-20

Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 32

Registration Number: NCT01431833

Locations: 🇺🇸
Trius Investigator Site 001, Orlando, Florida, United States
🇺🇸
Trius Investigator Site 002, Minneapolis, Minnesota, United States

TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Phase 3

Completed

Conditions: Skin and Subcutaneous Tissue Bacterial Infections

Interventions: Drug: Linezolid
Drug: TR-701 FA

First Posted Date: 2011-08-22

Last Posted Date: 2018-08-29

Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 666

Registration Number: NCT01421511

Locations: 🇷🇺
Trius investigator site 287, Barmaul, Russian Federation
🇿🇦
Trius investigator 451, Centurion, Gauteng, South Africa
🇿🇦
Trius investigator 449, Pretoria, Gauteng, South Africa

and more 108 locations

Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

Phase 1

Completed

Conditions: Bacterial Infection

Interventions: Drug: TR-701 FA

First Posted Date: 2011-01-07

Last Posted Date: 2019-11-15

Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 20

Registration Number: NCT01271998

Locations: 🇺🇸
Trius Investigator Site 001, Hartford, Connecticut, United States

TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

Phase 3

Completed

Conditions: Skin and Subcutaneous Tissue Bacterial Infections

Interventions: Drug: TR-701 FA
Drug: Linezolid

First Posted Date: 2010-07-27

Last Posted Date: 2018-08-29

Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 667

Registration Number: NCT01170221

Locations: 🇺🇸
Trius investigator site 135, Hialeah, Florida, United States
🇺🇸
Trius investigator site 133, Butte, Montana, United States
🇺🇸
Trius investigator site 120, Houston, Texas, United States

and more 81 locations