MFDS Approves NewGen Therapeutics COVID-19 Treatment Phase 1 Clinical Trial

[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety (Commissioner Kim Gang-rip) announced on the 3rd that it has approved the phase 1 clinical trial plan for NewGen Therapeutics' novel coronavirus disease (COVID-19) treatment, 'NewGen Nafamostat Tablets.'

NewGen Nafamostat Tablets are developed by changing the administration route to tablets to improve convenience compared to injections, using the ingredient (Nafamostat Mesylate) currently used as an anticoagulant.

The treatment mechanism works by inhibiting the virus's entry into cells, exhibiting antiviral efficacy.

This clinical trial will evaluate tolerability and safety in healthy adults.

In Korea, an injection with the same ingredient has been approved for clinical trials and is ongoing. Chong Kun Dang is at phase 2 clinical trials, and Gyeongsang National University Hospital is conducting investigator-initiated clinical trials. In the United States, clinical trials are being conducted on healthy individuals, and in Senegal, clinical trials are underway on COVID-19 patients.

Currently, there are a total of 21 clinical trials related to COVID-19 treatments and vaccines ongoing in Korea (19 treatments, 2 vaccines).

The Ministry of Food and Drug Safety stated, "As public interest in the development of COVID-19 treatments and vaccines remains high, we will continue to promptly provide information on the status of clinical trials for developed products."

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