Novo’s Wegovy Capsule Wins Weight problems Approval, Securing Lead in Oral GLP-1 Race
The FDA has permitted Novo Nordisk’s Wegovy tablet for weight administration, making the product the primary oral GLP-1 therapy for people who find themselves chubby or have weight problems within the U.S.
Novo’s tablet accommodates 25 mg of semaglutide, the GLP-1 receptor agonist discovered within the injectable model of Wegovy and its diabetes-indicated sibling Ozempic. The FDA permitted the product primarily based on knowledge together with a Section III trial that linked the Wegovy tablet to 16.6% imply weight reduction. Sufferers misplaced comparable quantities of weight on the once-daily oral and once-weekly injectable formulations of Wegovy.
BMO Capital Markets analysts stated in a observe to buyers that the approval is “a much-needed win in gentle of latest challenges sustaining incretin market share dominance.” Having initially led the GLP-1 market, Novo has misplaced floor amid competitors from injectables offered by Eli Lilly and compounding pharmacies.
The oral launch, which is ready for early January, once more establishes Novo as the primary entrant to a doubtlessly profitable market. “Novo will doubtless profit from first-mover benefit, capturing sufferers with a desire for comfort and luxury offered by an oral dosing routine,” BMO analysts stated.
But Novo might have a brief window through which to capitalize on its first-mover benefit. Lilly has filed for FDA approval of its oral GLP-1 candidate orforglipron and has a Commissioner’s Nationwide Precedence Voucher that might speed up regulatory evaluate. Ilya Yuffa, president of Lilly USA, stated at a Citi convention this month that the corporate expects to launch orforglipron early within the second quarter of 2026.
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This means Novo might have only a few months to ascertain a foothold within the oral GLP-1 market earlier than dealing with competitors. Common weight reduction on orforglipron in a Section III trial was 12.4%, in comparison with 13.7% on injectable Wegovy, in line with outcomes launched in August. Lilly’s shares initially fell 7% in response to the information, though analysts have since grow to be extra bullish of their expectations for orforglipron.
BMO analysts see orforglipron and different oral GLP-1 candidates as threats to the Wegovy tablet. The analysts stated the Wegovy tablet’s meals impact, which prevents sufferers from consuming, ingesting or taking different oral medicines for half-hour after dosing, “is more likely to restrict uptake upon approval of orforglipron and different orals with extra handy profiles.”
The analysts anticipate buyers to concentrate on Wegovy tablet gross sales in 2026, “particularly early within the launch when no true competitors exists.” BMO’s group named knowledge from a head-to-head trial of Novo’s CagriSema and Eli Lilly’s tirzepatide, the energetic ingredient in Mounjaro and Zepbound, anticipated in early 2026, as one other focus of investor curiosity.
Many buyers anticipate Novo’s drug mixture, which is below evaluate on the FDA, to match tirzepatide, the analysts stated. With noninferiority the baseline expectation, there’s scope for perceptions of Novo to enhance if CagriSema can beat tirzepatide. But BMO analysts stated they’re cautious as a result of early CagriSema outcomes have underperformed most expectations.
