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The challenges involved in developing a peptide in tablet form
included overcoming the stomach’s enzymatic breakdown and increasing
absorption across the gastric epithelium. It took a suitable GLP-1 RA
molecule – semaglutide – and an absorption enhancer – SNAC – to make
the world’s first oral GLP-1 RA a reality.1
b vs a weekly injectable (76.5% vs 23.5%, respectively).9
c vs an injectable (84% vs 16%, respectively).10
d Data were collected via the medeConnect GP omnibus. Four questions relating to GP treatment of type 2 diabetes were included in the September 2021 omnibus. Fieldwork was conducted between 9 September and 2 October 2021, with 1,000 UK GPs geographically representative (by region).
2008 - We decided to go ahead with oral insulin and oral GLP-1 RA development.
2010 - Our first phase 1 trial was initiated and moved to phase 2.
2016 - We initiated the PIONEER clinical trial programme13–22 and began major upscaling of production.
2019 - Our vision became a reality and oral semaglutide was approved in the US in 2019 and in Europe the following year.2,13–26
Buckley ST, Bækdal TA, Vegge A, et al. Transcellular stomach absorption of a derivatized glucagon-like peptide-1 receptor agonist. Sci Transl Med. 2018 Nov 14;10(467):eaar7047.
RYBELSUS® [summary of product characteristics]. Bagsværd, Denmark: Novo Nordisk A/S; March 2024.
Hinnen D. Glucagon-like peptide 1 receptor agonists for type 2 diabetes. Diabetes Spectr. 2017;30(3):202-210.
Cornell S. J Clin Pharm Ther. 2020;45(Suppl 1):17–27.
Reed J, et al. F1000Res. 2020 Apr 6;9:F1000 Faculty Rev-239. doi:10.12688/f1000research.20602.1. eCollection 2020.
Muskiet MHA, et al. Nat Rev Nephrol. 2017;13(10):605–628.
Spain VC, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported barriers to adherence and persistence to treatment with injectable medications for type 2 diabetes. Clin Ther. 2016;38(7):1653-1664.
Sikirica MV, Martin AA, Wood R, Leith A, Piercy J, Higgins V. Reasons for discontinuation of GLP1 receptor agonists: data from a real-world cross-sectional survey of physicians and their patients with type 2 diabetes. Diabetes Metab Syndr Obes. 2017;10:403-412.
Boye K, Ross M, Mody R, Konig M, Gelhorn H. Patients' preferences for once-daily oral versus once-weekly injectable diabetes medications: The REVISE study. Diabetes Obes Metab. 2021;23(2):508-519.
Dibonaventura MD, Wagner JS, Girman CJ, et al. Multinational Internet-based survey of patient preference for newer oral or injectable type 2 diabetes medication. Patient Prefer Adherence. 2010;4:397-406.
Novo Nordisk. Data on file. Data were collected via the medeConnect GP omnibus. Four questions relating to GP treatment of type 2 diabetes were included in the September 2021 omnibus. Fieldwork was conducted between 9 September and 2 October 2021, with 1,000 UK GPs geographically representative (by region).
Connor A, Donsmark M, Hartoft-Nielsen M-L, Søndergaard F, Bækdal TA. A pharmacoscintigraphic study of the relationship between tablet erosion and pharmacokinetics of oral semaglutide. Poster presented at the European Association for the Study of Diabetes (EASD): 11-15 September 2017; Lisbon, Portugal.
Aroda VR, Rosenstock J, Terauchi Y, et al. PIONEER 1: Randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes. Diabetes Care. 2019; 42:1724-1732.
Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: The PIONEER 2 trial. Diabetes Care. 2019; 42:2272-2281.
Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: The PIONEER 3 randomized clinical trial. JAMA. 2019; 321:1466-1480.
Pratley R, Amod A, Hoff ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, Phase 3a trial. Lancet. 2019; 394:39-50.
Mosenzon O, Blicher TM, Rosenlund S, et al. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, Phase 3a trial. Lancet Diabetes Endocrinol. 2019; 7:515-527.
Husain M, Birkenfeld AL, Donsmark M, et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2019; 381:841-851.
Pieber TR, Bode B, Mertens A, et al. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, Phase 3a trial. Lancet Diabetes Endocrinol. 2019; 7:528-539.
Zinman B, Aroda VR, Buse JB, et al. Efficacy, safety, and tolerability of oral semaglutide versus placebo added to insulin with or without metformin in patients with type 2 diabetes: The PIONEER 8 trial. Diabetes Care. 2019; 42:2262-2271
Yamada Y, Katagiri H, Hamamoto Y, et al. Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, Phase 2/3a, randomised, controlled trial. The Lancet Diabetes & Endocrinology. 2020; 8:377-391.
Yabe D, Nakamura J, Kaneto H, et al. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, Phase 3a trial. The Lancet Diabetes & Endocrinology. 2020; 8:392-406.
Novo Nordisk. Novo Nordisk files for EU regulatory approval of oral semaglutide for the treatment of type 2 diabetes. Available at: https://www.globenewswire.com/news-release/2019/04/26/1810371/0/en/Novo-Nordisk-files-for-EU-regulatory-approval-of-oral-semaglutide-for-the-treatment-of-type-2-diabetes.html last accessed April 2022
Novo Nordisk. Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic®. Available at: https://www.globenewswire.com/news-release/2019/03/20/1757907/0/en/Novo-Nordisk-files-oral-semaglutide-for-US-regulatory-approval-of-glycaemic-control-as-well-as-for-CV-risk-reduction-for-oral-semaglutide-and-Ozempic.html last accessed April 2022
Novo Nordisk. FDA approves RYBELSUS® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes. Available at: https://www.prnewswire.com/news-releases/fda-approves-rybelsus-semaglutide-the-first-glp-1-analog-treatment-available-in-a-pill-for-adults-with-type-2-diabetes-300922438.html last accessed April 2022
Novo Nordisk US. RYBELSUS® (oral semaglutide) US Prescribing Information. Available at: https://www.novo-pi.com/rybelsus.pdf. Accessed June 2020.
The information contained in this site is intended for healthcare professionals only outside of the United States of America. This site is not intended to provide medical advice and/or treatment guidance. Only a physician can determine whether a specific product is correct for a particular patient. This site is not country-specific and therefore may contain information which is not applicable to your country. Novo Nordisk accepts no liability for the accuracy, completeness or use of this information, and disclaims any liability to update the information contained on this site. By accessing this site and materials you accept this legal notice and expressly confirm your status as a healthcare professional. Any images shown are models and not real patients.
The Summary of Product Characteristics (SmPC) is based on the EU SmPC as of March 2024. Registration conditions differ internationally. Always refer to the full local SmPC before prescribing.