Mumbai : Pharmaceuticals major Glenmark has launched its patent protected and globally‐researched sodium glucose co‐transporter‐2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) in India. The drug is indicated in the treatment of type‐2 diabetes mellitus in adults.
SGLT2 inhibitors are novel anti‐diabetic drugs that help achieve glycemic control by acting on the SGLT2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. SGLT2 drugs provide glycemic control, induce weight loss and reduce cardiovascular risks.
Glenmark is the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin and India is the first country to get access to this innovative drug. Glenmark will commercialize Remogliflozin in India under the brand names “Remo” and “Remozen”.
Glenmark received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase‐3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head‐to‐head comparison against Dapagliflozin.
“Globally, SGLT2 inhibitors are emerging as a preferred treatment for management of type‐2 diabetes and Glenmark is proud to introduce a novel molecule in this class, which is cutting‐edge and
researched extensively. Diabetes is a key area of focus for Glenmark and with the launch of Remogliflozin, the company aims to improve access to SGLT2 inhibitors by providing an effective, high quality and world‐class treatment option to patients in India,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals.
Remogliflozin, the latest drug in SGLT2 inhibitors’ class to get regulatory approval in the world, has been studied in 26 clinical trials globally, covering around 2,500 people from various ethnicities.
Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical Co. Ltd. and later developed by GlaxoSmithKline plc and Glenmark collaborator BHV Pharma, a wholly owned subsidiary of Avolynt, Inc. which is based in North Carolina, USA. Glenmark secured certain rights to Remogliflozin through a licensing collaboration agreement with BHV Pharma, and conducted the Phase‐3 clinical trial.