Clinical Trials

Numerous clinical trials evaluate tedizolid across Phase 1 through Phase 4, predominantly targeting acute bacterial skin and skin structure infections, hospital-acquired pneumonia, prosthetic joint and bone infections, and other Gram-positive infections. Sponsored by both pharmaceutical companies and academic medical centers, these investigations range from early pharmacokinetic and safety assessments to post-marketing studies. While most trials are completed, several exhibit recruiting, terminated, or unknown recruitment statuses across diverse patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05398679 RECRUITING
Endocarditis Infective
Fundacion Clinic per a la Recerca Biomédica
 2022-08-17 PHASE4
NCT05534750 RECRUITING
Tuberculosis; Multidrug Resistant Tuberculosis
Assistance Publique - Hôpitaux de Paris
 2023-04-20 PHASE2
NCT06609161 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2024-07-16 PHASE1
NCT03746327 COMPLETED
Prostheses Infection
Fundacion Clinic per a la Recerca Biomédica
 2020-02-13 PHASE4
NCT03176134 COMPLETED
Acute Bacterial Skin and Skin Structure Infections
Merck Sharp & Dohme LLC
 2019-01-20 PHASE3
NCT03217565 COMPLETED
Gram-Positive Infections
Merck Sharp & Dohme LLC
 2019-02-06 PHASE1
NCT06733688 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2022-03-23 PHASE1
NCT03009045 COMPLETED
Bone and Joint Infection
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2017-02-06 PHASE2
NCT03378427 COMPLETED
Prosthetic Joint Infection
Tourcoing Hospital
 2018-08-28
NCT03746327 Unknown status
Prostheses Infection
Fundacion Clinic per a la Recerca Biomédica
 2020-03-01 Phase 4
NCT02750761 COMPLETED
Gram-Positive Bacterial Infections
Merck Sharp & Dohme LLC
 2016-05-02 PHASE1
NCT02276482 COMPLETED
Skin Diseases, Infectious; Skin Diseases, Bacterial
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2015-03-25 PHASE3
NCT02019420 COMPLETED
Pneumonia
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2014-01-06 PHASE3
NCT02444234 COMPLETED
Cystic Fibrosis
University of Southern California
 2015-07 PHASE4
NCT02620787 COMPLETED
Diabetes; Wound Infection; Healthy Volunteers
Hartford Hospital
 2016-02-23 PHASE1
NCT03009045 Completed
Bone and Joint Infection
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2017-02-06 Phase 2
NCT01967225 COMPLETED
Skin Diseases, Infectious
Bayer
 2013-11-23 PHASE3
NCT02066402 COMPLETED
Bacterial Infections
Bayer
 2014-03-04 PHASE3
NCT02342418 COMPLETED
Obesity
Amit.Pai
 2015-03 PHASE4
NCT02477514 COMPLETED
Skin Diseases, Bacterial
Merck Sharp & Dohme LLC
 2015-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-07)

Check the Tedizolid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an oxazolidinone-class antibacterial agent, tedizolid binds to the 50S ribosomal subunit of susceptible Gram-positive bacteria, preventing the formation of the functional 70S initiation complex and disrupting bacterial protein synthesis. This inhibition of translation halts bacterial growth and leads to pathogen eradication, providing strong therapeutic efficacy in clinical conditions such as acute bacterial skin and skin structure infections, pneumonia, and bone infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.