In short
Cineole (1,8-cineole) is a chemically synthesised substance being studied as an oral treatment for chronic Staphylococcus aureus carriage in the nasal cavity. The EU Clinical Trials Information System (CTIS) lists one trial: a withdrawn Phase 3 study that had planned to enrol 300 participants. The trial was designed to compare cineole alone and in combination with mupirocin against the infection.
Key points
- Cineole was studied in one Phase 3 trial for chronic nasal Staphylococcus aureus carriage.
- The trial was withdrawn before enrolling participants.
- Planned enrolment was 300 participants.
- The study compared oral cineole 600 mg against intranasal mupirocin.
- The primary outcome was microbiological clearance after 7 days of therapy.
- No results are available because the trial did not proceed.
What is cineole?
Cineole, also known as 1,8-cineole, is a chemically synthesised substance. It is registered in the EU Clinical Trials Information System (CTIS) under the name CINEOLE and is classified as a chemical substance rather than a protein-based one. In the trial record, cineole appears as the test substance, meaning it was the active treatment being investigated. The substance data indicate that cineole is authorised as a medicine, although the specific authorisation record is not detailed in the CTIS entry.
How does cineole work?
The CTIS record does not describe a molecular target or mechanism of action for cineole. The trial was designed to evaluate its effectiveness against methicillin-resistant Staphylococcus aureus (MRSA) in the nasal cavity, but the registry does not explain how cineole might act against the bacteria. Without supplementary sources, no mechanism of action can be stated.
Which conditions is cineole studied for?
The therapeutic area recorded in CTIS places cineole in otorhinolaryngologic diseases, which affect the ear, nose and throat. The single trial listed one condition:
- Chronic active Staphylococcus aureus mono-infection and asymptomatic carriage in the nasal cavity — a long-lasting presence of S. aureus bacteria in the nose, including MRSA strains, without necessarily causing symptoms.
How is cineole given?
In the planned trial, cineole was to be given by oral use at a dose of 600 mg. The comparison treatment, mupirocin, was to be given intranasally. No other pharmaceutical forms or routes of administration are recorded for cineole in this dataset.
What do the clinical trials show?
Only one trial of cineole is listed in the CTIS data. It was a Phase 3 interventional study with a planned enrolment of 300 participants. The trial status is withdrawn, meaning it was stopped before it started recruiting patients. Because the trial was withdrawn, no efficacy or safety results are available.
The primary outcome was the efficacy of cineole in monotherapy and combination therapy in patients with chronic active monoinfection or carriage of Staphylococcus aureus in the nasal cavity, as determined by microbiological analysis — both qualitative and quantitative — immediately after 7 days of therapy. The trial aimed to confirm whether cineole could clear the bacteria from the nasal cavity.
What side effects are known?
The CTIS record does not report any side effects for cineole, and no supplementary sources are provided. Therefore, no side effect information can be stated for this substance based on the available data.