Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
The FDA has approved Novo Nordisk’s Wegovy pill for weight management, making the product the first oral GLP-1 treatment for people who are overweight or have obesity in the U.S.
Novo’s pill contains 25 mg of semaglutide, the GLP-1 receptor agonist found in the injectable version of Wegovy and its diabetes-indicated sibling Ozempic. The FDA approved the product based on data including a Phase III trial that linked the Wegovy pill to 16.6% mean weight loss. Patients lost similar amounts of weight on the once-daily oral and once-weekly injectable formulations of Wegovy.
BMO Capital Markets analysts said in a note to investors that the approval is “a much-needed win in light of recent challenges maintaining incretin market share dominance.” Having initially led the GLP-1 market, Novo has lost ground amid competition from injectables sold by Eli Lilly and compounding pharmacies.
The oral launch, which is set for early January, again establishes Novo as the first entrant to a potentially lucrative market. “Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen,” BMO analysts said.
Yet Novo may have a short window in which to capitalize on its first-mover advantage. Lilly has filed for FDA approval of its oral GLP-1 candidate orforglipron and has a Commissioner’s National Priority Voucher that could accelerate regulatory review. Ilya Yuffa, president of Lilly USA, said at a Citi conference this month that the company expects to launch orforglipron early in the second quarter of 2026.
This suggests Novo may have just a few months to establish a foothold in the oral GLP-1 market before facing competition. Average weight loss on orforglipron in a Phase III trial was 12.4%, compared to 13.7% on injectable Wegovy, according to results released in August. Lilly’s shares initially fell 7% in response to the data, although analysts have since become more bullish in their expectations for orforglipron.
BMO analysts see orforglipron and other oral GLP-1 candidates as threats to the Wegovy pill. The analysts said the Wegovy pill’s food effect, which prevents patients from eating, drinking or taking other oral medications for 30 minutes after dosing, “is likely to limit uptake upon approval of orforglipron and other orals with more convenient profiles.”
The analysts expect investors to focus on Wegovy pill sales in 2026, “especially early in the launch when no true competition exists.” BMO’s team named data from a head-to-head trial of Novo’s CagriSema and Eli Lilly’s tirzepatide, the active ingredient in Mounjaro and Zepbound, expected in early 2026, as another focus of investor interest.
Many investors expect Novo’s drug combination, which is under review at the FDA, to match tirzepatide, the analysts said. With noninferiority the baseline expectation, there is scope for perceptions of Novo to improve if CagriSema can beat tirzepatide. Yet BMO analysts said they are cautious because early CagriSema results have underperformed most expectations.
