Rybelsus(Semaglutide)

Rybelsus (semaglutide) is an oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is administered once daily, starting at a recommended dose of 3 mg, increasing to 7 mg after one month, with a maximum dose of 14 mg. Semaglutide exhibits 94% sequence homology to human GLP-1. Its absolute bioavailability ranges from 0.4% to 1%, with an elimination half-life of 1 week.

Clinical trials demonstrated significant efficacy in glycemic control. Semaglutide reduced fasting glucose by 22% compared to placebo, and the overall 24-hour glucose profile by 22% compared to placebo. The reduction in AUC0-5 hr postprandial glucose ranged from 20-29% versus placebo. The HbA1c change from baseline ED50 was 6 mg.

Safety findings included a within-subject variability of single-dose oral semaglutide bioavailability of 137% in a controlled setting. The largest lower bound of the two-sided 90% CI for ΔΔQTcF for moxifloxacin was 5 ms. In clinical studies, 81.0% of patients on oral semaglutide completed treatment, compared to 87.6% on placebo. The regulatory review for NDA213051 involved 32 studies, including 9 Phase 3 studies, with a total of 8218 subjects.