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# Novo Nordisk Files 2 Semaglutide NDAs
- URL: https://www.fdaweb.com/novo-nordisk-files-2-semaglutide-ndas/
- Published: 2019-03-21T12:00:00.000Z
- Updated: 2026-09-15T01:14:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143671

Novo Nordisk has submitted two NDAs to FDA for oral semaglutide, the first once-daily glucagon-like peptide-1 receptor agonist in a pill. The company [says](https://www.novonordisk-us.com/media/news-releases.html?122958&ref=fdaweb.com) one NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with Type 2 diabetes. The company used a priority review voucher for this NDA and anticipates a six-month review time.

The second NDA seeks approval for an indication to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease. It has an anticipated 10-month review time.

At the same time, Novo Nordisk submitted an sNDA for once-weekly Ozempic (semaglutide) injection seeking an indication to reduce risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease. Ozempic was approved 12/5/17 for adults with Type 2 diabetes to improve blood sugar along with diet and exercise.

The company says the efficacy and safety of oral semaglutide were evaluated in 10 PIONEER clinical trials including 9,543 adults with Type 2 diabetes. In the trials, people treated with oral semaglutide were compared to those taking sitagliptin, empagliflozin, liraglutide, and placebo.