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Drug

Tedizolid phosphate

Approved · FDA
Emerging researchLate-stage development

Also known as Sivextro, Torezolid phosphate.

RxNorm1540824ChEMBLCHEMBL2105669UNIIO7DRJ6R4DW
1
Research papers
28
Regulatory events
Latest activity
beta

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

Label change: TEDIZOLID PHOSPHATE (NDA205435)

Regulatory2026-02-27FDA

Label change: TEDIZOLID PHOSPHATE (NDA205436)

Regulatory2026-02-27FDA

A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Clinical trial2025-07-31Results posted · ClinicalTrials.gov

A Phase 3 Study of the Safety and Efficacy of Tedizolid Phosphate in Patients <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections.

Research2025-04-14The Pediatric infectious disease journal

Indication expansion: TEDIZOLID PHOSPHATE (NDA205435)

Regulatory2025-04-04FDA

Indication expansion: TEDIZOLID PHOSPHATE (NDA205436)

Regulatory2025-04-04FDA

A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old

Clinical trial2025-02-11Results posted · ClinicalTrials.gov

Label change: TEDIZOLID PHOSPHATE (NDA205435)

Regulatory2021-11-17FDA

Label change: TEDIZOLID PHOSPHATE (NDA205436)

Regulatory2021-11-17FDA

Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections

Clinical trial2021-08-22Completed · ClinicalTrials.gov

Label change: TEDIZOLID PHOSPHATE (NDA205435)

Regulatory2020-10-22FDA

A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old

Clinical trial2019-12-20Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Tedizolid phosphate
Aliases & brands
SivextroTorezolid phosphate
RxNorm CUI
1540824
ChEMBL ID
CHEMBL2105669
UNII
O7DRJ6R4DW
Regulatory jurisdictions
fda

Regulatory timeline

28 events

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
2014-06-20
Latest approval
2025-04-04
Authorities
FDA
Total events
28
fdaU.S. Food and Drug Administration· 28 events
2026-02-27Label change
Label change: TEDIZOLID PHOSPHATE (NDA205436)
Evidence ↗
2026-02-27Label change
Label change: TEDIZOLID PHOSPHATE (NDA205435)
Evidence ↗
2025-04-04Indication expansion
Indication expansion: TEDIZOLID PHOSPHATE (NDA205436)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

8 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
8
registered trials across all phases
LATEST COMPLETION 2023
5
Late-stage (III+)
8
Completed
PHASE DISTRIBUTIONn = 8
Phase 13Phase 33Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Single Dose Pharmacokinetics of Intravenous Tedizolid Phosphate in Morbidly Obese and Age-, Sex-, and Ideal Body Weight-Matched Non-Obese Adults

CompletedPH IVAmit.Pain=192015

A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

CompletedPH IIIMerck Sharp & Dohme LLCn=1002023

A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia

CompletedPH IIICubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)n=7262018

A Prospective, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (Skin and Soft Tissue Infection [SSTI] and SSTI-related Bacteremia)

CompletedPH IIIBayern=1252016

Recent completions

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

A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

CompletedPH IIIMerck Sharp & Dohme LLCn=1002023

A Phase 1, Single- and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old

CompletedPH IMerck Sharp & Dohme LLCn=472023

Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections

CompletedN/ATourcoing Hospitaln=352021

A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old

CompletedPH IMerck Sharp & Dohme LLCn=322018

A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia

CompletedPH IIICubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)n=7262018

A Prospective, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of BAY 1192631 in Japanese Patients With MRSA Infections (Skin and Soft Tissue Infection [SSTI] and SSTI-related Bacteremia)

CompletedPH IIIBayern=1252016

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes4
Anti-Bacterial Agents1Organophosphates1Oxazoles1Skin Diseases, Bacterial1
Journals, researchers & institutions
Top journals
  • The Pediatric infectious disease journal1
Leading researchers
  • Boddicker M1
  • Broyde N1
  • Fofanov O1
  • Grazioso CF1
  • Koseoglu S1
  • Melgar Toledo M1
  • Mngqibisa R1
  • Romero L1
Leading institutions
free-text, unnormalised
  • Center for Pediatric Research1
  • From the Enhancing Care Foundation1
  • Ivano-Frankivsk Regional Children Clinical Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.