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Drug

Tedizolid phosphate

Established medicine
ClassBacterial 70S ribosome inhibitorResearchActive indication expansion

Also known as Sivextro, Torezolid phosphate.

RxNorm1540824ChEMBLCHEMBL2105669UNIIO7DRJ6R4DW
1
Research papers
55
Protein targets
28
Regulatory events
Latest activity
beta

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

Green stability-indicating RP-HPLC method for simultaneous bioanalysis of tedizolid phosphate and ciprofloxacin in human plasma

Industry2026-08-13Nature — Environmental Sciences

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

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
Primary mechanism
Bacterial 70S ribosome inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

55 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Small ribosomal subunit protein uS2
rpsB · P0A7V0
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL4
rplD · P60723
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein bS1
rpsA · P0AG67
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS10
rpsJ · P0A7R5
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS11
rpsK · P0A7R9
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS12
rpsL · P0A7S3
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS13
rpsM · P0A7S9
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS14
rpsN · P0AG59
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS15
rpsO · P0ADZ4
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein bS16
rpsP · P0A7T3
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS17
rpsQ · P0AG63
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein bS18
rpsR · P0A7T7
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS19
rpsS · P0A7U3
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein bS20
rpsT · P0A7U7
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein bS21
rpsU · P68679
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS3
rpsC · P0A7V3
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS4
rpsD · P0A7V8
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS5
rpsE · P0A7W1
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein bS6
rpsF · P02358
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS7
rpsG · P02359
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS8
rpsH · P0A7W7
INHIBITORBacterial 70S ribosome inhibitor
Small ribosomal subunit protein uS9
rpsI · P0A7X3
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL10
rplJ · P0A7J3
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL11
rplK · P0A7J7
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL13
rplM · P0AA10
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL14
rplN · P0ADY3
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL15
rplO · P02413
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL16
rplP · P0ADY7
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL17
rplQ · P0AG44
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL18
rplR · P0C018
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL19
rplS · P0A7K6
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL1
rplA · P0A7L0
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL20
rplT · P0A7L3
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL21
rplU · P0AG48
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL22
rplV · P61175
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL23
rplW · P0ADZ0
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL24
rplX · P60624
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL25
rplY · P68919
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL27
rpmA · P0A7L8
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL28
rpmB · P0A7M2
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL29
rpmC · P0A7M6
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL2
rplB · P60422
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL30
rpmD · P0AG51
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL31B
ykgM · P0A7N1
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL31
rpmE · P0A7M9
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL32
rpmF · P0A7N4
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL33
rpmG · P0A7N9
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL34
rpmH · P0A7P5
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL35
rpmI · P0A7Q1
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL36B
rpmJ2 · Q2EEQ2
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL36A
rpmJ1 · P0A7Q6
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL3
rplC · P60438
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL5
rplE · P62399
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein uL6
rplF · P0AG55
INHIBITORBacterial 70S ribosome inhibitor
Large ribosomal subunit protein bL12
rplL · P0A7K2
INHIBITORBacterial 70S ribosome inhibitor

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.