PNB Vesper, a leading Kerala-based life sciences company, announced on Tuesday that it has approached the Drugs Controller General of India (DCGI) and the government of India for an emergency use authorisation of its new drug to treat hospitalised Covid patients.
The company announced that it has successfully completed the Phase 2 clinical trials of its drug and submitted the final report of its proprietary drug PNB-001 (GPP-Baladol) to the DCGI.
GPP-Baladol is a novel and safe medicine that possesses significant efficacy to save hospitalised Covid patients with oxygen support from the deadly coronavirus, the company said.
PNB Vesper had initiated the clinical trials in October 2020 at the BJ Government Medical College in Pune and the Victoria Medical College and Research Institute in Bengaluru.
The clinical trial protocol was designed in line with the solidarity trial conducted by the WHO and other international bodies.
P.N. Balaram, CEO, PNB Vesper Life Sciences, said that GPP-Baladol is a promising drug for Covid-19 patients around the world, who are hospitalised with oxygen support.