Ildong Pharmaceutical Receives Approval to Change Clinical Trial Plan for Oral COVID-19 Treatment

[Asia Economy Reporter Lee Gwan-joo] Ildong Pharmaceutical announced on the 24th that it has received approval from the Ministry of Food and Drug Safety for changes to the Phase 2/3 clinical trial plan of the oral COVID-19 treatment 'Zokova (S-217622)', which is being jointly developed with Japan's Shionogi Pharmaceutical.

On the 11th of this month, Ildong Pharmaceutical applied to the Ministry of Food and Drug Safety to reduce the number of mild to moderate patients participating in Phase 3 clinical trials from 1,785 to 1,590 and to extend the trial period from July to September this year.

This change reflects the global clinical plan modification made by Shionogi Pharmaceutical in consultation with Japanese regulatory authorities in July, which has been incorporated into the domestic Phase 3 clinical trial design. This was done to revise parts that differed from the initial plan during the clinical trial process.

Zokova is an oral COVID-19 treatment being developed by Ildong Pharmaceutical and Shionogi Pharmaceutical, and the Phase 3 administration has currently been completed.

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