On December 5, 2017, the FDA approved the listing of Novo Nordisk's hypoglycemic drug Semaglutide, the first oral GLP-1 analogue.
Prior to the approval of the market launch of Semaglutide, all of the GLP-1 analogues of the hypoglycemic agents were administered by subcutaneous injection and no oral drugs were marketed.
The Novo Nordisk official website published the results of phase II clinical trial of oral GLP-1 analogue Semaglutide (drug code OG217SC) on February 20, 2015. Clinical data showed oral Somaru Semaglutide treatment of type 2 diabetes has reached the expected clinical treatment index.
This has led to a broad spectrum of diabetic patients seeing hope from oral GLP-1 analogue drugs.
Semaglutide (USAN; trade name Ozempic) is a pharmaceutical drug developed by Danish company Novo Nordisk for the treatment of type 2 diabetes. As a glucagon-like peptide-1 receptor agonist, it lowers the blood sugar level by increasing the production of insulin. It was discovered in 2012, by a team of researchers at Novo Nordisk as a longer-acting alternative to liraglutide.
In humans, Semaglutide is chemically similar to glucagon-like peptide-1 (GLP-1). The only differences are two amino acid substitutions at positions 8 and 34, where 2-aminoisobutyric acid and arginine are present, respectively. In addition, lysine at position 26 is in its derivative form (acylated with stearic diacid ).
On December 5, 2017, Semaglutide was approved by the US FDA. It can be used as both injection-type or oral-type drug. The marketing authorization in EU was granted on 8 February 2018.
Semaglutide is a GLP-1 analogue and functions as a GLP-1 agonist. Researchers at the University of Leeds and Novo Nordisk reported in 2017 that it can also be used for the treatment of obesity. It reduces hunger, food craving, and body fat.
Data from the SUSTAIN study show that Semaglutide controls HbA1 levels at all stages of the disease. The drug also significantly reduces patient weight compared to sitagliptin (SUSTAIN-2), compared to exenatide controlled release (SUSTAIN-3), and compared with insulin glargine (SUSTAIN-4), both have statistically significant advantages. The SUSTAIN-6 study showed that the drug also improved cardiovascular function, reducing the risk of stroke by 39% and reducing the risk of myocardial infarction by 26%.
Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in development for the treatment of type 2 diabetes (T2D). It has 94% homology to native GLP-1 but, due to three structural modifications, has a half-life of approximately 1 week following subcutaneous administration, allowing for once-weekly dosing. A comprehensive clinical development program, including six global phase IIIa trials, established the efficacy and safety of Semaglutide at multiple stages in the management of T2D and versus various existing medications, showing that Semaglutide consistently provided significantly, sustained improvements in glycemic control versus comparators, enabling the majority of subjects to achieve the glycated hemoglobin target of < 7% (< 53 mmol/mol).
Semaglutide also consistently provided clinically significant reductions in body weight that, with the 1.0 mg dose, were at least twofold as great as those with the respective comparator in each trial. These improvements in glycemic control and body weight were achieved along with a low risk of hypoglycemia. Furthermore, semaglutide demonstrated a significant, beneficial effect on cardiovascular outcomes and a safety profile similar to that of other GLP-1 receptor agonists. Additional trials indicate a potential for no dose adjustment of semaglutide in different patient populations or with common concomitant medications.
- Semaglutide.GLP-1 receptor agonist, Treatment of type 2 diabetes Chudleigh, R., Bain, S.C.
- "Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes"(Press release). Novo Nordisk. December 5, 2016.
- "Novo Nordisk A/S: Ozempic® (semaglutide) approved in the EU for the treatment of type 2 diabetes".globenewswire.com. 9 February 2018. Retrieved2018-08-19.
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