Ipca Laboratories Launches Diulcus for Diabetic Foot Ulcer Treatment

Ipca Laboratories has introduced a pioneering topical gel, Diulcus, to address diabetic foot ulcers (DFUs) in India. This innovative product, priced at ₹1,365 per 15 mg pack, will become available through Ipca’s extensive network of 4,000 distributors across the country. With a target of capturing a ₹100 crore market within the next 3 years, Diulcus marks a significant advancement in the treatment of DFUs.

Developed by Pune-based NovaLead, Diulcus represents a novel application of the beta blocker Esmolol, originally approved for treating rapid heart rates. By repurposing Esmolol into a topical gel, NovaLead has created a formulation that has demonstrated efficacy in wound healing. The licensing agreement between Ipca and NovaLead includes a ₹13 crore upfront payment, along with royalties and milestone-linked payments.

Diulcus has undergone rigorous testing, with phase-3 clinical trials showcasing impressive results. The gel achieved a 60.3% ulcer closure rate within three months of treatment, with a continued closure rate of 77.20% over six months, even after discontinuation of treatment. This makes Diulcus a potentially transformative option for DFU patients, who traditionally face challenging and often inadequate treatment options.

Diabetic foot ulcers, which affect around 15% of diabetic patients, are a leading cause of lower limb amputations. The condition is prevalent among India’s large diabetic population, which includes 10 crore people with diabetes and 13.6 crore with pre-diabetes, according to the ICMR-INDIAB 2023 study. The high mortality rate associated with DFUs, at 46% over five years, underscores the critical need for effective treatments.

The Executive Chairman of Ipca, Premchand Godha, highlighted the significance of Diulcus’ approval, noting its potential to address a pressing medical need and its alignment with Ipca’s commitment to advancing diabetes therapy. The launch of Diulcus reflects Ipca’s dedication to improving patient outcomes and tackling one of the most challenging complications of diabetes.

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