Zelnite® 2024-05-21T17:47:22+00:00

Project Description


Zelnite® is a selenium injection product for the treatment of selenium deficiency or for the prevention of selenium deficiency in patients receiving parenteral nutrition. It was approved by the Ministry of Health and Welfare for new drug listing in 2018, originally packaged as 100 mcg/2 mL ampoule. Following the development of a high-dose selenium injection (originally Rexis®, 500 mcg/10 mL vial), a phase III clinical trial (CARE-SEPS study) to evaluate its efficacy as add-on treatment in septic patients was simultaneously conducted at seven major medical centers in Taiwan. The trial has been completed, and clinical data indicate that the high-dose selenium injection demonstrates good safety and tolerability. Although the primary endpoint of reducing mortality did not achieve statistical significance, clinical data indicate that many septic patients were deficient of selenium, and the high-dose selenium injection can rapidly restore low selenium levels in septic patients, thereby reducing the hospital length of stay. The results of the phase III clinical trial was published in the international journal Medical Research Archives in February 2024, showing that severe selenium deficiency significantly affects the mortality rate of septic patients, and increasing serum selenium levels helps improve survival rates and reduce organ failure indices.

TaiRx’s marketed product Zelnite® was originally a low-dose selenium injection (2 mL ampoule). Based on the above phase III clinical data, new drug dosage and high-dose selenium injection (10 mL vial) of Zelnite® were approved by TFDA in May 2024 for market release to expand the product’s user population and to meet the medical needs.