The U.S. Food and Drug Administration has approved the first oral GLP-1 treatment for obesity, marking a significant shift in how weight loss drugs could be accessed by patients in the United States.
The pill, developed by Novo Nordisk, uses the same active ingredient as the company’s blockbuster injectable drug Wegovy and is expected to launch in early 2026.
Novo Nordisk confirmed that from early January, the starting 1.5 milligram dose will be available through pharmacies and selected telehealth providers at a price of $149 per month for eligible cash-paying patients.
That pricing mirrors an agreement struck with the Trump administration, which allows patients to access the same starting dose through President Donald Trump’s direct-to-consumer platform, TrumpRx, when it launches in January.
The company did not disclose pricing for higher doses but said further information on coverage and savings programmes would be provided closer to launch.
Investors reacted positively to the announcement, with Novo Nordisk shares rising around 10% in extended trading following the FDA decision.
Expanded Health Benefits And Market Impact
Beyond weight loss, the FDA approval also clears the pill for use in reducing the risk of major cardiovascular events such as heart attack, stroke, and death in adults with obesity who already have established cardiovascular disease.
This mirrors the approved use of Wegovy, reinforcing confidence in the safety and effectiveness of the oral version.
Both treatments work by mimicking the gut hormone GLP-1, which suppresses appetite and helps regulate blood sugar levels.
“What we’ve learned through years of research is that having an oral option really kind of opens up, activates and motivates different segments to seek treatment,” said Dave Moore, Novo Nordisk’s executive vice president of U.S. operations.
“To have that conversation with their doctor to see if this is something that might be right for them.”
Moore added that the pill offers familiarity for patients due to its shared ingredient with Wegovy and could encourage people who are hesitant about injections to seek treatment.
Competition And The Future Of GLP-1 Pills
Health experts believe oral treatments could appeal to patients who fear needles or who may not see their condition as severe enough to justify injections.
While exact usage figures are unclear, surveys suggest around one in eight U.S. adults have taken a GLP-1 drug for weight loss or another chronic condition.
The approval gives Novo Nordisk a strategic advantage over rival Eli Lilly, which is developing its own obesity pill and currently dominates the injectable market with Zepbound.
Analysts see pills as the next major battleground in a market some estimate could reach $100 billion by the 2030s.
Goldman Sachs analysts have suggested pills could represent nearly a quarter of the global weight loss drug market by the end of the decade.
BMO Capital Markets analyst Evan Seigerman described the approval as a “much-needed win” for Novo Nordisk amid increasing competition.
“Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen,” Seigerman said.
Trial Results And Practical Considerations
The FDA approval was supported by a phase three trial involving more than 300 adults with obesity who did not have diabetes.
Patients taking a 25 milligram dose lost an average of up to 16.6% of their body weight after 64 weeks.
When all participants were included regardless of treatment discontinuation, average weight loss was recorded at 13.6%.
While the pill appears slightly more effective than Eli Lilly’s experimental oral drug, Novo Nordisk’s treatment requires patients to wait 30 minutes before eating or drinking after taking it.
Moore said similar restrictions exist for other common medicines and do not significantly impact adherence.
“It’s actually a reinforcement factor for patients,” he said.
Novo Nordisk also positioned the pricing as a way to discourage demand for unapproved compounded versions of GLP-1 drugs, which surged during recent shortages.
The company said manufacturing is already underway at its North Carolina facilities and it is prepared to meet strong U.S. demand.
