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# Novo Nordisk Plans NDA for Oral Obesity Drug
- URL: https://www.fdaweb.com/novo-nordisk-plans-nda-for-oral-obesity-drug/
- Published: 2023-05-22T12:00:00.000Z
- Updated: 2026-09-14T18:33:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154506

Novo Nordisk says it will seek FDA approval for obesity drug semaglutide 50 mg tablets after announcing that the Phase 3a OASIS 1 trial met its primary endpoint — demonstrating a statistically significant and superior weight loss at week 68 versus placebo. Injectabe semaglutide (Wegovy) was approved in 2021 for treating obesity ([see earlier story](https://www.fdaweb.com/novo-nordisk-drug-approved-for-weight-loss/)).

“The results show comparable weight loss as in the STEP 1 trial with injectable semaglutide 2.4 mg in obesity branded as Wegovy,” the company says. “The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and healthcare providers the opportunity to choose what best suits individual treatment preferences.”

It says that data from the OASIS 1 trial showed that if all people “adhered to treatment from a mean baseline body weight of 105.4 kg, people treated with oral semaglutide 50 mg achieved a statistically significant weight loss of 17.4% after 68 weeks compared to a 1.8% reduction with placebo. In addition, 89.2% of those who received oral semaglutide 50 mg, reached a weight loss of 5% or more after 68 weeks, compared to 24.5% with placebo.”