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PKN605 is an investigational substance, meaning it has not been granted marketing authorisation as a medicine in the product records of the trial.[1] It is a chemical substance, developed by Novartis Pharma AG.[1] In the trial registry, it appears under the product name PKN605.[1]
The available registry data do not describe the mechanism of action of PKN605. The trial is designed to evaluate its effect on atrial fibrillation burden, which is the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time.[1]
PKN605 is given as a film-coated tablet by mouth (oral use).[1] The trial also includes a placebo to PKN605 50 mg film-coated tablets as a comparison arm.[1] The dose of PKN605 itself is reported as 00 mg in the registry, which means the exact dose was not reported in the register.[1]
One clinical trial of PKN605 is registered in the EU Clinical Trials Information System (CTIS).[1] It is a Phase 2 interventional study with the identifier 2025-520518-79-00 and the status “Authorised”.[1] The trial plans to enroll 165 participants with atrial fibrillation.[1]
The main measure in this trial is atrial fibrillation burden (AFB) from ECG patch monitors, defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time.[1] The study also investigates efficacy, safety, tolerability and pharmacokinetics, which means how the body absorbs, distributes, breaks down and removes the medicine.[1]
The registry data do not list side effects of PKN605. The trial is designed to evaluate safety and tolerability, so this information may become available when the study reports results.[1]
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