Bukwang Pharmaceutical's 'Rebovir' Receives FDA Approval for Phase 2 Clinical Trial as COVID-19 Treatment

40 Confirmed COVID-19 Cases Excluding Severe Cases

[Asia Economy Reporter Kim Ji-hee] Bukwang Pharmaceutical announced on the 5th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical trial plan of Levovir (active ingredient: Clevudine) as a COVID-19 treatment.

This clinical trial will be conducted on outpatients using a placebo-controlled, randomized, double-blind design. Levovir and placebo will be administered to 40 COVID-19 patients excluding severe cases, to evaluate the efficacy and safety by measuring how much Levovir can reduce the amount of COVID-19 virus in patients' bodies compared to placebo.

Levovir has already completed patient enrollment for a Phase 2 clinical trial conducted domestically on moderate patients. The results analysis is forthcoming. Since January, an additional clinical trial has been underway to confirm the reduction of live infectious virus through COVID-19 virus cell culture tests of Levovir.

A Bukwang Pharmaceutical official stated, "We have accumulated extensive clinical experience through global trials of antiviral agents, central nervous system drugs, and diabetes treatments," adding, "Through this clinical trial, we expect to prove the reduction of the COVID-19 virus and secure clinical data not only from domestic trials but also from U.S. trials, thereby demonstrating international competitiveness as an antiviral agent."

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