NovaLead Pharma announced that the drug regulator in India, CDSCO has approved their patented repurposed drug for the treatment of Diabetic Foot Ulcer (DFU).
DFU is one of the most prevalent complications caused by chronic diabetes. The approval of NovaLead’s patented repurposed drug is significant because DFU is the leading cause of lower limb amputations globally, with about 100,000 annual incidences in India alone.
This drug is a novel topical gel formulation of Esmolol hydrochloride, which is already approved in several countries for cardiac conditions via intravenous injection. Thus, this novel topical gel discovered and developed by NovaLead is a new indication as well as a new formulation to be first launched in India. NovaLead has been granted patents for this drug in several countries including regulated markets of USA, EU and Japan.
Supreet Deshpande, CEO, NovaLead Pharma said that the development of this drug was partly funded by BIRAC, a Government of India initiative. Deshpande also mentioned that the drug will be made available to DFU patients in India through an exclusive IP licensing arrangement with NovaLead.