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Drug

Tedizolid

Approved · EMA
Late-stage development

Also known as Sivextro, Torezolid.

RxNorm1540825ChEMBLCHEMBL1257051UNII97HLQ82NGL
2
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Clinical trial2026-07-07Results expected Q4 2026 · ClinicalTrials.gov

Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections

Clinical trial2023-12-13Results posted · ClinicalTrials.gov

Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis

Clinical trial2020-06-02Results posted · ClinicalTrials.gov

Comparative Assessment of Tedizolid Tissue Penetration and Pharmacokinetic Profile Between Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Clinical trial2019-01-15Results posted · ClinicalTrials.gov

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Clinical trial2017-06-07Results posted · ClinicalTrials.gov

Approval: Sivextro (EMA)

Regulatory2015-03-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tedizolid
Aliases & brands
SivextroTorezolid
RxNorm CUI
1540825
ChEMBL ID
CHEMBL1257051
UNII
97HLQ82NGL
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-03-23
Latest approval
2015-03-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2015-03-23Approval
Approval: Sivextro (EMA)
Indication: Sivextro tablets are indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, adolescents and children weighing at least 35… Show full indication

Sivextro tablets are indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, adolescents and children weighing at least 35 kg.Consideration should be given to official guidance on the appropriate use of antibacterial agents. Sivextro powder for concentrate for solution for infusion is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) from birth. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

6 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
6
registered trials across all phases
LATEST COMPLETION 2021
2
Active studies
2
Recruiting
3
Late-stage (III+)
4
Completed
PHASE DISTRIBUTIONn = 6
Phase 11Phase 22Phase 31Phase 42

Recent completions

Trials that read out recently, adding to the completed evidence base.

Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections

CompletedPH IILundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centern=442021

Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis

CompletedPH IVUniversity of Southern Californian=112017

Comparative Assessment of Tedizolid Tissue Penetration and Pharmacokinetic Profile Between Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

CompletedPH IHartford Hospitaln=182017

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

CompletedPH IIIBayern=5982016
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.