ISSAR’s journey of peptide R&D to address unmet medical needs
Formed as a company driven by pharmaceutical innovation to address the unmet healthcare needs, ISSAR pharmaceuticals Pvt. Ltd. was founded in 1995 by Mr Ramakrishna Isanaka. Mr. Isanaka solely established ISSAR at a period during which India was majorly into manufacturing generic drugs. He was keen on research and indigenous development of peptide-based drug molecules in India. ISSAR’s purpose lies in the development of new technologies at an affordable price to improve quality of life for Indian population.
With over 25 years of experience and prime focus in Research and Development, ISSAR’s dedicated team of experts are proud to have developed India’s first ever peptide molecule, MELGAIN for the treatment of Vitiligo in 2004. In the year 2002, ISSAR conducted the first human clinical trials (phase-I) for Melgain and emerged as the first and only company to have conducted phase-I clinical trials in India since independence. Later in 2003, after successful completion of clinical trials, ISSAR commercialised their first ever peptide solution for Vitiligo. In the succeeding year, Dr Reddy’s Laboratories (DRL), successfully launched Melgain into the market in India in 2004. Melgain was established as a safe and efficacious solution for treating Vitiligo, with positive results in 80-90% of patients. Over the years, with improved properties and effectiveness, Melgain has now been introduced as Novoskin, an advanced version of the same.
ISSAR’s commitment has also led to the development of their second New Chemical Entity called Xylentra, which is the first ever peptide drug in the world for the treatment of burn wounds and microbial infections. In 2006 ISSAR bagged the DCGI approval for phase-I and II clinical trials for Xylentra, a peptide based topical drug developed for second degree burn wounds and infections. Recently ISSAR has also developed molecules for prevalent conditions in the Western world such as Inflammatory Bowel Diseases (IBD), Psoriasis and Sepsis.
With an undisputed vision and continuous advancement in developing innovative peptide therapeutics, in 2012, ISSAR established their FDA-compliant state-of-the-art manufacturing facility of 62000 sq.ft in Genome Valley, Hyderabad, India, as the only pharmaceutical company working as a purely peptide manufacturing technology based company. As ISSAR continued to develop molecules for different disease areas, they had also completed phase-I clinical trials for cancer (solid tumours) in the following year. In 2014, progressing further, ISSAR successfully completed phase-III clinical trials for Xylentra and got the DCGI approval for manufacturing the same in 2019.
In addition to its experience in R&D, ISSAR is equipped with the most advanced and automated technology for synthesis and purification of peptides, producing highest standards of purity of up to 99.5% by continued process optimization. As the future holds an extensive place for peptides as safe and efficient therapeutics with excellent diagnostic, preventive and curative properties, ISSAR constantly emphasizes on quality, safety and innovation through peptide drug discovery. Through their journey of 25 years, today, ISSAR has successfully commercialized 2 peptide drugs, acquired several patents for potential life changing peptide molecules lined up in their developmental pipeline, targeting therapeutic areas such as oncology, dermatology, gastroenterology (IBD), and diseases of bones and joints (Rheumatoid Arthritis), touching over 1,00,000 lives.