Tedizolid Phosphate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 377

Clinical Trials

Tedizolid phosphate has been evaluated in numerous Phase 1 through Phase 4 clinical trials to assess its safety, pharmacokinetic profile, and therapeutic efficacy against various bacterial infections. Sponsored by pharmaceutical companies and clinical research institutions, these studies target conditions such as acute bacterial skin and skin structure infections, pneumonia, infective endocarditis, prosthetic joint infections, and diabetic wound infections. The overall trial portfolio includes completed, actively recruiting, and terminated studies.

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
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
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 Phosphate 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 prodrug, tedizolid phosphate is converted to active tedizolid, which selectively binds to the 50S subunit of the bacterial ribosome to prevent 70S initiation complex formation, thereby inhibiting bacterial protein synthesis and halting bacterial proliferation. This targeted inhibition of translation underlies its therapeutic efficacy against susceptible Gram-positive pathogens in clinical conditions such as acute bacterial skin structure infections, pneumonia, and prosthetic joint 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>).