PNB Vesper has received permission from the Drugs Controller General of India (DCGI) to enter into the phase-III clinical trials of PNB 001/GPP-BALACOVIN, the company said in a statement.
After a detailed deliberation by the Subject Expert Committee (SEC) on the phase-II clinical trial results of PNB – 001 (GPP-BALACOVIN), the company has now been given a green signal to conduct a nation-wide multi-centered phase-III clinical trial on hospitalised COVID-19 patients with oxygen support. The phase-III trial will be conducted on a large patient population in 12 hospitals all over India. GPP-BALACOVIN is a novel and safe drug that possesses significant efficacy to save the hospitalised patients with oxygen support from coronavirus, it added.