Novo Nordisk has received approval from the U.S. Food and Drug Administration (FDA) for its Wegovy pill, making it the first oral GLP-1 treatment available in the United States for people who are overweight or have obesity.
The new product contains 25 mg of semaglutide, the same active ingredient found in both the injectable version of Wegovy and Novo’s diabetes drug Ozempic. The FDA’s decision was based on clinical data, including a Phase III trial that showed patients taking the Wegovy pill lost an average of 16.6% of their body weight. Weight loss results were similar between those using the daily oral formulation and those using weekly injections.
BMO Capital Markets analysts commented on the development, stating, “a much-needed win in light of recent challenges maintaining incretin market share dominance.” They noted that while Novo initially led in the GLP-1 market, it has faced increased competition from Eli Lilly’s injectables and products from compounding pharmacies.
The company plans to launch the oral medication in early January. BMO analysts added, “Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen.”
However, this advantage may be short-lived. Eli Lilly has submitted its own oral GLP-1 candidate, orforglipron, for FDA approval and holds a Commissioner’s National Priority Voucher that could speed up regulatory review. Ilya Yuffa, president of Lilly USA, said at a Citi conference earlier this month that Lilly expects to launch orforglipron early in the second quarter of 2026.
This timeline suggests Novo Nordisk may only have several months before facing direct competition in the oral GLP-1 space. In a Phase III trial released in August, patients taking orforglipron lost an average of 12.4% body weight compared to 13.7% for injectable Wegovy; initial investor reaction saw Lilly shares fall by 7%, but analyst sentiment has since improved regarding orforglipron's prospects.
BMO analysts see potential threats to Novo’s new product as more oral GLP-1 candidates enter the market. They stated that one limitation is “the Wegovy pill’s food effect,” which requires patients to avoid eating, drinking or taking other medications for 30 minutes after dosing—a factor they believe “is likely to limit uptake upon approval of orforglipron and other orals with more convenient profiles.”
Looking ahead to 2026, BMO analysts expect investor attention will focus on sales performance during Wegovy pill’s initial months without true competition. They also pointed out that data from a head-to-head trial comparing Novo’s CagriSema combination therapy with Eli Lilly’s tirzepatide (the main ingredient in Mounjaro and Zepbound), expected early next year, will be closely watched by investors.
According to BMO analysts: “Many investors expect Novo’s drug combination…to match tirzepatide.” While noninferiority is seen as a baseline expectation for CagriSema versus tirzepatide, perceptions could improve if CagriSema demonstrates superior results—though BMO remains cautious due to underwhelming early data.
