Ipca Laboratories Launches Diulcus for Diabetic Foot Ulcer Treatment

India, on the brink of becoming the diabetes capital of the world by 2030, with a number predicted to rise to 64.30 crores, faces an alarming rise in diabetes cases, with 10 crore individuals currently diagnosed and another 13.6 crore affected by pre-diabetes, according to the ICMR-INDIAB 2023 study.

About Diabetic Foot Ulcer (DFU)

Diabetic foot ulcers (DFU), a prevalent complication, impact around 15 percent of diabetic patients, leading to an estimated 100,000 lower limb foot amputations annually in India.

The high mortality rate associated with DFUs, at 46% over five years, underscores the critical need for effective treatments.

About Ipca Laboratories

Ipca is a fully integrated pharmaceutical company with a strong focus on exports. It operates with vertical integration, producing both finished dosage forms (PDFs) and active pharmaceutical ingredients (APIs). It is one of India’s top 20 pharmaceutical companies and stands out for its comprehensive approach.

IPCA Laboratories has launched the pioneering topical gel Diulcus, a treatment specifically designed to address diabetic foot ulcers (DFU).

Diulcus, a topical treatment developed through drug repurposing, has received approval from the Central Drugs Standard Control Organization (CDSCO) and was partially funded by the Biotechnology Industry Research Assistance Council (BIRAC), a Government of India enterprise.

Developed by Pune-based NovaLead Pharma, 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.

The gel ointment, priced at Rs 1,365 for a 15-gram tube, is expected to require 6-7 tubes for a complete treatment course, which can last anywhere between 12 and 24 weeks. Notably, 20 percent of the cost is subsidized by the government, making it more accessible to patients in need.

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, offering hope for a condition that often leads to severe outcomes like lower limb amputations. This makes diulcus a potentially transformative option for DFU patients, who traditionally face challenging and often inadequate treatment options.

Currently, only a limited number of physicians specialize in diabetes foot ulcers since there is no product available on the market. The launch of Diulcus reflects Ipca’s dedication to improving patient outcomes and tackling one of the most challenging complications of diabetes.

The product will be distributed through IPCA’s extensive network, focusing on the 2,000 doctors who specialize in diabetes treatment across India.

Ipca has priced Diulcus 15 mg gel at Rs 1365 per pack and will soon make it available across its pan-India network of 4000 distributors.

With this new drug, the company is targeting a Rs 100 crore market within the next three years. Diulcus marks a significant advancement in the treatment of DFUs.

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