Last month Novo Nordisk submitted two new drug applications (NDAs) to the FDA for its glucagon-like peptide-1 receptor agonist (GLP-1RA), oral semaglutide, a novel formulation of injectable semaglutide, Ozempic.

One NDA is with priority review towards controlling blood glucose levels in type 2 diabetes (T2D) patients, and the other towards reducing major adverse cardiovascular (CV) events in T2D patients with established CV disease. Growth in the GLP-1RA space continues to be heavily driven by agents that confer glycemic benefit, non-glycemic benefits (for example, weight loss, CV benefit), and increased patient compliance.

Results from the PIONEER trial, a study investigating oral semaglutide, indicates that the agent is already proving to fulfil most of the aforementioned criteria, potentially resulting in the drug becoming the new market leader within the GLP-1RA space.

Overall, the GLP-1RA class continues to undergo major diversification, primarily regarding mode of administration. Historically, the class was made up of agents that were delivered via once- or twice-daily injections, but in the past few years, novel marketed GLP-1RAs have begun to offer once-weekly administration.

Once-weekly GLP-1RA competitors, such as Eli Lilly’s Trulicity (dulaglutide), continue to steal market share from Novo Nordisk’s GLP-1RA blockbuster drug, Victoza. In anticipation of GLP-1RA market trends, Novo Nordisk developed a follow-up once-weekly GLP-1RA of its own, Ozempic (semaglutide), which is a variant of Victoza and was shown to significantly reduce CV risk in T2D patients in the SUSTAIN-6 trial.

Implications of Novo Nordisk oral GLP-1

GlobalData believes oral semaglutide can become the new market leader in the GLP-1RA space within the next decade, despite stiff competition with existing GLP-1RAs. This will most likely be due to the novel agent being given as a once-daily pill, in contrast to all marketed GLP-1RAs, which are administered via injection.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Despite the arrival of injectable GLP-1RAs that only require an injection once per week, it is expected that patients will still prefer, and be more compliant on, a once-daily non-injectable substitute. In about six months’ time, the fate of oral semaglutide in the US will be known, with Novo Nordisk in position to continue its dominance in the GLP-1RA space if and when the FDA grants approval.

Image credit: News Øresund – Johan Wessman – – CC BY 3.0.