Boryeong Launches Korea's First Non-Alcoholic Docetaxel Anticancer Drug 'Ditaxel'

Ethanol Component Removed... Preventing Risks of Alcohol Side Effects

Boryung announced on the 29th that it has launched 'Ditaxel,' the first non-alcoholic docetaxel liquid formulation anticancer drug in Korea.

Non-alcoholic docetaxel liquid formulation anticancer drug 'Ditaxel'.
[Image provided by Boryung]

Ditaxel (active ingredient docetaxel), first launched in 2012, is a taxane-based anticancer drug mainly used for breast cancer treatment. It has various indications including non-small cell lung cancer, prostate cancer, ovarian cancer, head and neck cancer, stomach cancer, and esophageal cancer. The newly released product replaces the additive ethanol in the existing docetaxel product with another additive, reducing symptoms caused by alcohol content.

The main ingredient of Ditaxel, docetaxel, is poorly soluble in water, so ethanol is added during the manufacturing process to compensate for this. Because of this, there is a risk of ethanol-induced symptoms similar to those experienced after alcohol consumption when administering docetaxel. Approximately 0.5 ml of ethanol additive is contained per 1 ml of docetaxel, so patients receive a considerable amount of ethanol when using high-dose products.

In fact, the U.S. Food and Drug Administration (FDA) has warned that docetaxel contains ethanol, and patients may experience alcohol intoxication or feel intoxicated during and after treatment. Domestic studies also showed that 44.3% of patients administered docetaxel products reported ethanol-related symptoms such as facial flushing, nausea, and dizziness. Due to these side effect risks, non-alcoholic products have already been developed and prescribed in the U.S. and Japan.

Accordingly, Boryung has introduced the first non-alcoholic docetaxel liquid formulation product in Korea. The company began developing a product replacing the alcohol component in 2019 and obtained approval for changes from the Ministry of Food and Drug Safety on the 27th after four years of research and development. Ditaxel is a non-alcoholic product that uses high-purity solvents to enhance stability, and a patent for the related composition has also been registered.

With no non-alcoholic liquid formulation products currently available, Boryung expects Ditaxel to be recognized as a new treatment option. Additionally, having a high-dose product of 120 mg is considered an advantage as it can reduce drug costs and improve preparation convenience.

Kim Young-seok, head of Boryung's Onco division, said, "Ditaxel is the only non-alcoholic docetaxel liquid formulation in Korea that can reduce various symptoms caused by alcohol during docetaxel administration. We will continue to carefully consider the patient’s treatment process and do our best to develop differentiated products that can further improve treatment outcomes."

This content was produced with the assistance of AI translation services.