Oral Wegovy's Pending Approval Raises Questions About High-Dose Peptide Viability

Novo Nordisk's oral semaglutide, a high-dose peptide formulation of the popular weight loss drug Wegovy, is nearing FDA approval. This development has sparked discussions about manufacturing capabilities, market competition, and the future of oral peptides in the pharmaceutical industry.

Novo Nordisk Confident in Manufacturing Capacity

Novo Nordisk has assured investors that it has the necessary manufacturing capacity to support the launch of oral semaglutide without supply restrictions. The company's spokesperson stated, "It will be produced in the U.S. for U.S. patients, and we are confident that we can launch it with no restrictions on supply." This confidence is backed by substantial investments, including $6.5 billion in U.S. manufacturing capacity this year alone.

The oral formulation requires a significantly higher dose than its injectable counterpart, with 25 mg daily compared to 2.4 mg weekly for injectable Wegovy. Despite this tenfold increase, Novo Nordisk CFO Karsten Munk Knudsen expects a "non-supply-restricted" launch in the U.S. next year.

Industry Debates Viability of High-Dose Peptides

The pending approval of oral Wegovy has ignited a debate about the maximum commercially viable dose for GLP-1 peptides. Brian Hubbard, chief scientific officer at Metsera, suggests that 25 mg is at the threshold of scalability, stating, "[Oral peptides for obesity] are not scalable once you're over 25 mg—just the ability to serve a market this size is extremely difficult to do."

However, other companies are exploring even higher doses. Viking Therapeutics is testing oral doses up to 120 mg of its dual GLP-1/GIP receptor agonist VK2735 in Phase IIa trials. Viking CEO Brian Lian acknowledges that profit margins are worse at higher doses but notes recent improvements in peptide production pricing may change the feasibility of oral dosing.

Competition and Market Dynamics

The oral GLP-1 market is becoming increasingly competitive. Eli Lilly's small molecule candidate orforglipron, despite showing lower-than-expected weight loss in Phase III trials, is still planned for regulatory filing this year. While small molecule manufacturing is generally cheaper than peptides, BMO Capital Markets analyst Evan Seigerman believes that "clinical profile is going to drive the narrative and market share."

Novo Nordisk's oral semaglutide has emerged as a frontrunner in the oral segment following Eli Lilly's setback. The company is also working on improving its formulations, with its spokesperson noting, "Novo Nordisk is continuously improving the formulation of our oral biologics to require as little [active pharmaceutical ingredient] as possible." This approach has precedent, as seen with the company's diabetes drug Rybelsus, which received approval for lower doses after its initial launch.

As the pharmaceutical industry awaits the FDA's decision on oral Wegovy in the fourth quarter, the spotlight remains on the viability and potential impact of high-dose peptides in the treatment of obesity and related conditions.