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Ethacizine is a chemically synthesised substance that has been authorised as a medicine in Latvia under the name Etacizīns 50 mg apvalkotās tabletes.[1] It belongs to the cardiovascular disease area and is classified under the ATC code C01BC09.[1] The substance is also known by other names, including etmozine, etacizin, and the development code NIK-244.[2]
In the clinical trial listed in the EU Clinical Trials Information System, ethacizine is the substance being tested, not a comparison.[1]
Ethacizine is a chemical substance with the molecular formula C 22 H 27 N 3 O 3 S.[2] It is listed as an ingredient substance in the FDA's Unique Ingredient Identifier system, where it is recorded under the UNII code FE5SPV1Z6G.[2] The substance is authorised as a medicine in Latvia, with the authorisation record LV 98-0371 held by OLPHA AS.[1] In the trial data, ethacizine appears as a film-coated tablet given by mouth.[1]
Ethacizine is known by several other names. These include etmozine, etacizin, ethacyzin, and the development code NIK-244.[2] The name Etacizīns 50 mg apvalkotās tabletes is the product name used in the trial record.[1]
The available sources do not describe the molecular mechanism of action of ethacizine in detail. The trial record places ethacizine in the cardiovascular disease area, and the study is designed to evaluate whether it can help maintain a normal heart rhythm in people with atrial fibrillation.[1] The ATC code C01BC09 places ethacizine among medicines used for heart conditions.[1]
Ethacizine is given as a film-coated tablet by mouth.[1] In the clinical trial, the ethacizine arm uses Etacizīns 50 mg apvalkotās tabletes, with a total daily dose of 200 milligrams.[1] The comparison medicine, propafenone, is given at a total daily dose of 900 milligrams by mouth.[1]
The clinical trial data contains one trial for ethacizine, registered in the EU Clinical Trials Information System with the number 2025-521267-13-01.[1] The trial is a phase 3, open-label, randomised study in atrial fibrillation.[1] It has 104 participants and is currently authorised.[1]
The trial compares ethacizine with propafenone over a 6-month treatment period. The main outcome measured is the recurrence of atrial fibrillation after sinus rhythm has been restored.[1] The study is designed to evaluate whether ethacizine is effective for maintaining sinus rhythm in people with atrial fibrillation.[1]
The trial is interventional, meaning participants receive one of the two medicines and are followed over time.[1] The trial record does not provide detailed information about who can take part beyond the condition studied.[1]
The available sources do not provide information about side effects of ethacizine. The FDA UNII record notes that the presence of a UNII code does not imply any regulatory review or approval of the substance.[2]
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