IPCA Laboratories Ltd launches Diulcus® to address Diabetic Foot Ulcer (DFU) in India

New Delhi: As per the ICMR-INDIAB (2023) study, 10 crore people in India suffer from diabetes, with an additional 13.6 crore people affected by pre-diabetes. This significant health concern positions India to become the diabetes capital of the world by 2030.

In response to this serious healthcare challenge, IPCA Laboratories Ltd proudly announces the launch of Diulcus®, a novel product aimed at addressing the challenges of Diabetic Foot Ulcer (DFU) in the Indian market. Diulcus®, developed by NovaLead Pharma Pvt Ltd, a pioneer in drug repurposing, represents a significant advancement in the management of DFU. The product 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.

The launch event was graced by esteemed personalities, including Sri. Ajit Jain, Dr A.P.S. Suri, Dr Achintya Sharma, Dr Anil Pareek, Sri Sunil Ghai, Sri. Supreet Deshpande.

During phase 3 trials in India, Diulcus® demonstrated remarkable efficacy, with a 60.3% ulcer closure rate within three months of treatment. Remarkably, patients continued to show an ulcer closure rate of 77.20% over six months, even after stopping treatment at three months. These results are among the best observed for any pharmaceutical preparation used in DFU treatment.

Sri. Ajit Jain, Managing Director of IPCA Laboratories Ltd, expressed his enthusiasm about the launch, stating, "With over 15% of diabetic patients suffering from DFU at least once in their lifetime, DFU is the most prevalent complication caused by chronic diabetes. The approval of this patented repurposed drug is significant because DFU is the leading cause of lower limb amputations globally. We are delighted to partner with NovaLead Pharma Pvt Ltd through an IP licensing arrangement to bring Diulcus® to DFU patients in India. It demonstrates IPCA’s commitment towards the patients suffering from unmet medical needs and its focus on diabetes therapy."

Dr. A.P.S. Suri, Foot Care Specialist (Podiatrist), said, “With the launch of Diulcus®, we are writing a new chapter in the treatment of diabetic foot ulcers. This product can not only revolutionize the treatment of DFU but also help reduce the complications associated with it, such as amputation, infection, and long-term pain. Given the rising incidence of diabetic foot ulcers in India, this product will not only be an important tool for physicians but can also significantly improve the quality of life of patients. This product is effective in helping in healing diabetic ulcers, helping them heal faster and preventing amputation of the feet. I congratulate IPCA Laboratories Limited and NovaLead Pharma Private Limited for bringing this important innovation to the Indian market and hope that this product will become a ray of hope for millions of patients in our country.”

Diulcus® will be made available to DFU patients by IPCA Laboratories Ltd. (IPCA) through an exclusive IP licensing arrangement with NovaLead Pharma PVT LTD for the Indian Market beginning in August 2024.

About Diabetic Foot Ulcer (DFU)

Over 537 million adults are living with diabetes globally, and the number is predicted to rise to 643 million by 2030. About 15% of diabetics suffer from DFU at least once in their lifetime, with 25% of DFUs eventually requiring amputation. DFU is a leading cause of lower extremity amputation. The five-year mortality post-amputation is 46%. DFU is a serious disease with very limited drug options and a very high cost of treatment.

About Diulcus® (Esmolol Ilydrochloride)

Diulcus® is a prescription medicine used to treat people with diabetic foot ulcer with no clinical infection. Infected DFUs need to be first treated for infection if existing and then put on Diulcus® treatment for wound closure. A doctor will perform independent assessment of DFU extent to determine the dose to be applied topically on the patient's DFU. Treating clinicians are advised to refer to the full prescribing information of Diulcus®.

About IPCA Laboratories Ltd (IPCA)

IPCA is a fully integrated pharmaceutical company with a strong thrust on exports. IPCA is vertically integrated and produces Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs).