Product Description
Tedizolid phosphate is a novel oxazolidinone prodrug (converted to the active form tedizolid by phosphatases in vivo) that has been developed and recently approved (June 2014) by the United States FDA for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). Tedizolid is an oxazolidinone, but differs from other oxazolidinones by possessing a modified side chain at the C-5 position of the oxazolidinone nucleus which confers activity against certain linezolid-resistant pathogens and has an optimized C- and D-ring system that improves potency through additional binding site interactions. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/25673021/)
Mechanisms of Action: 50S Ribosomal Subunit Antagonist, Protein Synthesis Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Czech | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Italy | Japan | Korea | Latvia | Lithuania | Malaysia | Mexico | Netherlands | Norway | Philippines | Poland | Portugal | Russia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Taiwan | Turkey | United Kingdom | United States | Vietnam
Approved Indications: None
Company: Cubist
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Communicable Diseases|Cystic Fibrosis
Phase 3: Soft Tissue Infections|Communicable Diseases
Phase 2: Communicable Diseases|Skin Diseases, Bacterial|Skin Diseases, Infectious|Erysipelas|Cellulitis|Abscess|Tuberculosis, Multidrug-Resistant
Phase 1: Communicable Diseases|Wound Infection|Healthy Volunteers|Kidney Diseases|Other
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05534750 |
TEDITUB | P2 |
Recruiting |
Tuberculosis, Multidrug-Resistant |
2026-04-01 |
2025-02-04 |
Primary Completion Date|Primary Endpoints |
|
NCT03746327 |
PROTEDI | P4 |
Completed |
Communicable Diseases |
2024-01-31 |
2025-03-13 |
Primary Endpoints |
|
NCT04662736 |
TediSAT | N/A |
Completed |
Other |
2021-02-01 |
2021-06-22 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT02991131 |
DART | N/A |
Terminated |
Skin Diseases, Bacterial|Communicable Diseases|Skin Diseases, Infectious |
2018-11-21 |
2019-10-03 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
NCT02444234 |
HS-15-00182 | P4 |
Completed |
Cystic Fibrosis |
2017-12-31 |
2022-05-04 |
Primary Endpoints|Treatments |
|
NCT02620787 |
Nicolau-53466 | P1 |
Completed |
Communicable Diseases|Wound Infection |
2017-03-01 |
2022-05-04 |
Primary Endpoints|Treatments |
|
2015-002780-42 |
Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients | P1 |
Active, not recruiting |
Unknown |
2016-12-29 |
2025-07-04 |
||
CTR20140216 |
CTR20140216 | P3 |
Completed |
Soft Tissue Infections |
2016-04-18 |
2025-04-29 |
Patient Enrollment|Treatments |
|
NCT02066402 |
NCT02066402 | P3 |
Completed |
Communicable Diseases |
2016-03-06 |
2022-05-04 |
Primary Endpoints|Treatments |
|
NCT01421511 |
TR701-113 | P3 |
Completed |
Unknown |
2013-01-10 |
2023-12-08 |
||
NCT01519778 |
TR701-126 | P2 |
Completed |
Erysipelas|Abscess|Cellulitis |
2012-08-27 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT01431833 |
TR701-124 | P1 |
Completed |
Unknown |
2012-05-01 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT01452828 |
TR701-123 | P1 |
Completed |
Kidney Diseases |
2012-03-01 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT01496677 |
TR701-109 | P1 |
Completed |
Healthy Volunteers |
2012-02-28 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT01461460 |
TR701-115 | P1 |
Completed |
Healthy Volunteers |
2011-12-23 |
2024-11-27 |
Primary Endpoints |
|
2010-022168-11 |
2010-022168-11 | N/A |
Completed |
Unknown |
2011-09-30 |
2022-03-13 |
Treatments |
|
NCT01156077 |
TR701-111 | P1 |
Completed |
Other |
2011-09-24 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT01271998 |
TR701-119 | P1 |
Completed |
Healthy Volunteers |
2011-01-03 |
2023-12-08 |
Primary Endpoints |
|
NCT00983255 |
IV/SAD/MAD | P1 |
Completed |
Healthy Volunteers |
2010-01-01 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT00876655 |
TR701-108 | P1 |
Completed |
Healthy Volunteers |
2009-03-01 |
2023-12-08 |
Primary Endpoints |
|
NCT00761215 |
TR701-104 | P2 |
Completed |
Skin Diseases, Infectious|Skin Diseases, Bacterial|Communicable Diseases |
2009-02-24 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT00666601 |
TR701-102 | P1 |
Completed |
Healthy Volunteers |
2008-08-12 |
2023-12-08 |
Primary Endpoints|Treatments |
|
NCT00671814 |
SAD/MAD | P1 |
Completed |
Healthy Volunteers |
2008-06-06 |
2023-12-08 |
||
NCT00671359 |
TR701-103 | P1 |
Completed |
Healthy Volunteers |
2008-05-15 |
2025-08-27 |
Primary Endpoints |
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