[Asia Economy Reporter Choi Dae-yeol] Daewoong Pharmaceutical announced on the 7th that it has received approval from the Philippine Food and Drug Administration (PFDA) for a Phase 1 clinical trial plan to verify the effectiveness of 'DWRX2003' (active ingredient Niclosamide) as a treatment for COVID-19.


This is the second overseas clinical approval following the approval of the Phase 1 clinical trial plan in India. The company will begin the first administration this month on 40 COVID-19 patients in the Philippines. They plan to confirm the safety, tolerability, and efficacy of DWRX2003. The company intends to proceed to Phase 2 clinical trials after completing this Phase 1 trial. After securing Phase 2 results, they plan to pursue local emergency approval and apply for Phase 3 clinical trial plans and product usage authorization.


Niclosamide, the active ingredient in DWRX2003, is one of the anthelmintic agents that activates autophagy in cells to inhibit viral replication. In previous animal experiments conducted by Daewoong Pharmaceutical, it showed a reduction effect on the COVID-19 virus.





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