Novo Nordisk announced that the U.S. Food and Drug Administration approved its first oral GLP‑1 weight‑loss drug, the Wegovy‑in‑a‑pill, on December 22, 2025. The approval marks the company’s first non‑injectable GLP‑1 therapy and positions it as the first to bring an oral weight‑loss pill to market.
The new formulation contains semaglutide, the same active ingredient used in the injectable Wegovy. The approved regimen starts at 1.5 mg once daily and escalates to a maintenance dose of up to 25 mg, mirroring the dosing schedule of the injectable version. Novo plans to launch the pill in the United States in early January 2026 and has set a starting price of $149 per month for cash‑pay patients, with the same price available through President Donald Trump’s TrumpRx platform to provide a discounted option.
The approval expands Novo’s obesity franchise by offering a convenient, once‑daily pill that can deliver weight‑loss results comparable to the injectable Wegovy. By eliminating the need for injections, the company can reach a broader patient population, including those who are hesitant about needles, and strengthen its competitive position against rivals such as Eli Lilly, whose oral GLP‑1 candidate, orforglipron, remains pending FDA review.
Financially, Novo reported third‑quarter sales of 74.9 billion Danish kroner (about $11.5 billion), up 5 % from the same period in 2024. GLP‑1 sales accounted for 36.7 billion kroner, also up 5 % YoY, underscoring robust demand for the company’s obesity products. The FDA approval triggered a positive market reaction, with the stock rising roughly 8 % in after‑hours trading, reflecting investor confidence in the new revenue stream.
Management emphasized the significance of the launch. EVP of U.S. operations Dave Moore said the pill “provides the most affordable self‑pay price to date in a GLP‑1 for obesity” and highlighted the company’s readiness for a full U.S. launch. CEO Mike Doustdar added that the oral Wegovy “offers patients a convenient, once‑daily pill that can help them lose as much weight as the injectable version,” underscoring the product’s potential to accelerate growth in the obesity market.
The approval also builds on Novo’s experience with Rybelsus, the first oral GLP‑1 for type 2 diabetes, and positions the company to capture a larger share of the growing obesity treatment market. With the oral formulation, Novo can leverage its established manufacturing and distribution network while offering a lower‑cost, patient‑friendly alternative to injectables, giving it a strategic advantage as the market for GLP‑1 therapies expands.
The FDA approval of the Wegovy pill is a pivotal event that expands Novo Nordisk’s obesity portfolio, enhances patient access, and strengthens its competitive edge in a rapidly growing market.
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