Linezolid clinical trials
Linezolid is named as an intervention in 18 current clinical trials in our China, Japan, India, Denmark, USA, Italy, Poland, Brazil, Mexico, South Korea, France, Spain, Netherlands, Taiwan, Singapore, Australia, Israel, Switzerland, Canada and Egypt registers. 11 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Beijing Chest Hospital (4). The most-studied condition is Pulmonary Tuberculosis. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Linezolid is approved
All regulators →Of the three regulators tracked here, the first to approve Linezolid was the US, on 18 Apr 2000. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Linezolid
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Linezolid works
All drug targets →- Bacterial 70S ribosome inhibitor InhibitorChEMBL only
- FeverPhase 3
- HIV infectious diseasePhase 3
- SepsisPhase 3
- Drug-resistant tuberculosisPhase 3
- Gram-positive bacterial infectionsPhase 3
- ImpetigoPhase 3
- MeningitisPhase 3
- Methicillin-resistant staphylococcus aureus infectious diseasePhase 3
- Multidrug-resistant tuberculosisPhase 3
- NeurosyphilisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL126, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10827, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Linezolid
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 9 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Linezolid
- ATC code
- J01XX08
- ChEMBL
- CHEMBL126
- DrugBank
- DB00601
- PubChem CID
- 441401
- CAS number
- 165800-03-3
- FDA UNII
- ISQ9I6J12J
- Wikidata
- Q411377
- Wikipedia
- Linezolid
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Linezolid
18 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Linezolid in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Linezolid. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Model-informed precision dosing for linezolid: a randomized clinical trial
2024-517888-23-00 · Bacterial Infections and Mycoses
|
Phase 3 | Authorised | University Medical Center Hamburg-Eppendorf | Germany |
|
Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci
2026-526149-91-00 · Bacterial Infections and Mycoses
|
Phase 3 | Authorised | Friedrich-Schiller-Universitaet Jena | Germany |
|
EPISSOC : Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standard of Care for the management of complicated pleural infections
2025-524697-42-00 · CTIS ↗ · Respiratory Tract Diseases
|
Phase 3 | Authorised | Centre Hospitalier Universitaire Amiens Picardie | France |
Linezolid across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
9 single-substance products containing Linezolid on the HPRA medicines list.
- Linezolid 2 mg/ml solution for infusionKRKA, d.d., Novo mesto · PA1347/057/002 · Marketed
- Linezolid 2 mg/ml solution for infusionFresenius Kabi Deutschland GmbH · PA2059/011/001 · Marketed
- Linezolid 600 mg film-coated tabletsRowex Limited, · PA0711/230/001 · Marketed
- Linezolid Clonmel 600 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/238/001 · Marketed
- Linezolid Krka 600 mg film-coated tabletsKRKA, d.d., Novo mesto · PA1347/057/001 · Marketed
Supply shortages
No entry for Linezolid in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Linezolid
25 conditionsAll 25 conditions
| Condition (as registered) | Trials |
|---|---|
| Pulmonary Tuberculosis | 3 |
| Tuberculosis | 2 |
| Mycobacterium Abscessus Infection | 2 |
| Antibiotic Prophylaxis | 2 |
| Mycobacterium Avium Complex Pulmonary Disease | 2 |
| Diabetic Foot Infection | 1 |
| Tuberculous Meningitis | 1 |
| Rifampicin-Resistant Pulmonary Tuberculosis | 1 |
| Multidrug-Resistant Pulmonary Tuberculosis | 1 |
| Meningitis | 1 |
| Bone | 1 |
| Joint | 1 |
| Drug-resistant Tuberculosis | 1 |
| Rifampin-resistant Tuberculosis | 1 |
| Monotherapy | 1 |
| Rifampicin-resistant Tuberculosis | 1 |
| General Surgery | 1 |
| Endocarditis Infective | 1 |
| Pulmonary Disease Due to Mycobacteria (Diagnosis) | 1 |
| Cystectomy | 1 |
| Bladder Cancer Requiring Cystectomy | 1 |
| Postoperative Infections | 1 |
| Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia) | 1 |
| Non-Tuberculous Mycobacterial (NTM) Pneumonia | 1 |
| Double J Stent | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Linezolid trials
How many clinical trials are testing Linezolid?
18 current trials in our China, Japan, India, Denmark, USA, Italy, Poland, Brazil, Mexico, South Korea, France, Spain, Netherlands, Taiwan, Singapore, Australia, Israel, Switzerland, Canada and Egypt registers name Linezolid as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Linezolid trials recruiting patients?
Yes. 11 of the 18 trials are recruiting: 4 with sites in China, 3 with sites in Japan, 2 with sites in India, 2 with sites in Denmark, 1 with sites in USA, 1 with sites in Italy, 1 with sites in Poland, 1 with sites in Brazil, 1 with sites in Mexico, 1 with sites in South Korea, 1 with sites in France, 1 with sites in Spain, 1 with sites in Netherlands, 1 with sites in Taiwan, 1 with sites in Singapore, 1 with sites in Australia, 1 with sites in Israel and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Linezolid clinical trials?
Beijing Chest Hospital (4), Bin Cao (2), MicuRx (1) and National Institute of Allergy and Infectious Diseases (NIAID) (1), among 14 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Linezolid licensed in Ireland?
Yes. The HPRA medicines list includes 9 single-substance products containing Linezolid, for example Linezolid 2 mg/ml solution for infusion (KRKA, d.d., Novo mesto). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Linezolid shortage?
Not in the lists we track: Linezolid has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Linezolid works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Linezolid works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Linezolid (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.