How Long Has Rybelsus Been on the Market?
Rybelsus (oral semaglutide) was approved by the U.S. Food and Drug Administration in September 2019, making it approximately 5 years old as of 2024. 1, 2, 3
Regulatory Approval Timeline
- Rybelsus received FDA approval in September 2019 as the first oral formulation of a GLP-1 receptor agonist for the treatment of type 2 diabetes in adults 1, 2, 3
- This approval marked a significant milestone, as Rybelsus was the first in its drug class to be administered in a once-daily oral form, expanding treatment options beyond injectable GLP-1 receptor agonists 1
- In Japan, oral semaglutide (Rybelsus) was approved for manufacturing and marketing following the earlier approval of the injectable formulation (Ozempic) in March 2018 4
Context Within the Semaglutide Product Line
- Injectable semaglutide (Ozempic) preceded Rybelsus, having been approved and used worldwide for type 2 diabetes treatment before the oral formulation became available 4
- Wegovy (semaglutide 2.4 mg injection for obesity) was approved in 2021-2022 by regulatory agencies in the USA and Europe, making it the most recent semaglutide formulation to reach the market 5
Clinical Development Program
- The PIONEER phase 3a clinical trial program assessed oral semaglutide's efficacy and safety in more than 9,500 patients before its 2019 approval, evaluating doses of 3 mg, 7 mg, and 14 mg 3
- These trials demonstrated that oral semaglutide provided greater HbA1c reductions than placebo, empagliflozin, or sitagliptin at 26 weeks, with 55-77% of patients on the 14 mg dose achieving HbA1c <7% 3
Technological Innovation
- Rybelsus was co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl]amino) caprylate (SNAC), which enabled oral administration of a peptide drug that would otherwise be degraded in the gastrointestinal tract 4
- This formulation breakthrough addressed the unmet need for patients who benefit from GLP-1 receptor agonist therapy but are unwilling to use injectable medications 2