Sevelamer Hydrochloride Set to Become a Generic Blockbuster

Sevelamer Hydrochloride Set to Become a Generic Blockbuster

FGF23Sevelamer Hydrochloride, CAS number 152751-57-0 is efficacious when used to treat patients with kidney disease who are on dialysis. As patients with kidney disease have low blood levels of phosphorus, sevelamer binds with phosphorus in patients’ everyday diet, and prevents it from being absorbed into the blood stream. In capsule form, sevelamer is typically taken three times daily, with meals. Side effects may include constipation, vomiting, stomach pain, diarrhea, headache and cough. Known as the brand Renagel, marketed by Genzyme Corporation, doses are available in both 400 and 800 milligram strengths. With the patent of Renagel due to expire in September of 2014, researchers are currently seeking to develop a generic formulation of this successful product. Genzyme has stated that Renagel is the most-prescribed phosphate binder in the United States. LGM Pharma is a provider of the API sevelamer hydrochloride, and offers client support throughout the entire R&D process.

Sevelamer-HCLIn March 2012 the Clinical Journal of the American Society of Nephrology reported exciting information regarding the use of sevelamer to treat patients with diabetes and early kidney disease. As inflammation is apparent in these patients, researchers aimed to determine the efficacy of sevelamer on the HbA1c, general inflammation and advanced glycation end products. This randomized trial was completed in two months, 2-month, in an intention-to-treat, crossover study.  Patients were dosed sevelamer carbonate or calcium carbonate treatment, specifically those in stages two to four chronic kidney disease. Participants received  two months of treatment with one of the drugs, either sevelamer carbonate or calcium carbonate, then had a one week washout. After that week break patients recieved the opposite drug (whichever they did not previously receive) for two more months. Conclusions of researchers were extremely positive, who found sevelamer carbonate to significantly reduces HbA1c, as well as fibroblast growth factor 23, lipids. Patient markers of inflammation and oxidative stress were significantly decreased, while antioxidant markers in patients showed formidable increases.  Patients with type 2 diabetes mellitus who are dosed with sevelamer may very well  be able to help to control their progression of early diabetic chronic kidney disease, based on these encouraging results. Continued study of sevelamer is crucial to the future treatment of patients with chronic kidney disease, which continues to grow worldwide with the increase in patients with type 2 diabetes.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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