The U.S. Food and Drug Administration on Monday permitted the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts reported could allow treatment access to many patients.
Novo Nordisk stated that it anticipates launching the drug in early 2026. The Danish drugmaker asserted that they could start in early January, the starting dose of 1.5 milligrams will now be available in pharmacies and through select telehealth providers, along with savings offers for $149 a month.
The same price that cash-paying patients can now access the starting dose of the pill on President Donald Trump’s direct-to-consumer official website, TrumpRx, on a deal Novo Nordisk made with his administration in the previous month. Trump’s website will be introduced in January.
Novo Nordisk did not confirm on how much bigger the doses of the drug would price, but affirmed additional information on coverage and savings options, which is available for eligible patients that will be available at that time.
According to Novo Nordisk, Novo Nordisk’s shares surged marginally by around 10 percent in expanded trading on Monday. The approval of the FDA informs the importance of the use of the pill to reduce the risk of major cardiovascular events, including death, heart attack, or stroke, in adults with obesity and established cardiovascular disease.
It’s compatible with the approval label of the company’s significant weight loss drug Wegovy, which shares the exact active ingredient, semaglutide. Both work by mimicking the gut hormone GLP-1 to suppress appetite.
Novo Nordisk’s Executive Vice President of U.S. operations, Dave Moore, informed CNBC on the ongoing approval that “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. To have that conversation with their doctor to see if this is something that might be right for them.”
He added, “That’s what we’re excited about — to be able to give people an option and make sure we have access and ease of access like we have been doing with our injections.” He stated that patients will have the “comfort and familiarity” on the matters of safety and efficacy, as the pill has the same active ingredient as Wegovy.
Few health experts reported that the pills might reach people who are afraid of needles or patients who might benefit from the current injections, but do not take them, as they don’t view their need as severe enough.
As per a poll from health policy research organization KFF, it’s not clear exactly how many of the individuals are utilizing GLP-1s in the U.S., specifically for obesity in particular. Although around 1 in 8 adults stated that they were using a GLP-1 drug to lose weight or treat another chronic condition as of November.
The approval provides Novo Nordisk a head start over its chief rival Eli Lilly, which is currently the prominent giant in the market and is intended to launch its own obesity pill.
Pills are the next competitors for the two drugmakers, which established the booming GLP-1 space, some analysts say; it could be about $100 billion by the 2030s.
Wall Street anticipates that there’s plenty of room for pills in the market, with Goldman Sachs analyst stating in August that pills could take over about 24 percent of the share or $22 billion of the 2030 global weight loss drug market.
A note on Monday affirmed that, BMO Capital Markets analyst Evan Seigerman said that the approval of Novo Nordisk’s pill gives the company a “much-needed win in light of recent challenges maintaining incretin market share dominance.”
Incretins, also known to treat that mimic gut hormones such as GLP-1. Eli Lilly earlier this year gained the biggest share of the market, as the credit goes to its blockbuster obesity injection Zepbound, which has indicated to be more effective than Novo Nordisk’s Wegovy.
Seigerman added that “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. But he also noted that the market is “rapidly evolving with competitive assets in development” and an approval for Eli Lilly’s pill, orforglipron, “just around the corner.”
The approval depends on a phase three trial that came after more than 300 adults with obesity but not diabetes.
In that research study, a 25-milligram dose of Novo Nordisk’s oral semaglutide assisted patients in losing up to 16.6 percent of their weight on average after 64 weeks, in accordance with the results from the trial presented at a medical conference in 2024.
The weight loss was 13.6 percent when the company analyzed all patients regardless of whether they stopped the drug. The pill proved to be marginally more effective than an experimental oral drug from Eli Lilly, which is still waiting for FDA approval.
Instead of Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide medication. Which refers to substances absorbed more efficiently by the body and do not require dietary restrictions. People who opt for Novo Nordisk’s pill have to wait 30 minutes before eating or drinking each day.
Moore added that many of the existing medicines have the same dietary requirements, so “we don’t see it as something that impacts adherence to treatment.”
He also highlighted that Novo Nordisk’s research has intended to help patients to remember to take their medicine in the morning with a few sips of water. He said, “It’s actually a reinforcement factor for patients.”
He also indicated that the prices of the pill get costs closer to what some people are paying for an unapproved one, the compounded versions of branded GLP-1s, some of which are still being illegally marketed and sold in the U.S.
Patients opted for the cheaper copycats, as Ozempic and Wegovy were in short supply over the past two years due to skyrocketing demand, or because they do not have insurance coverage for the pricey treatments.
At the timethe FDA-announced shortages, pharmacists can legally offer compounded versions of brand-name medications. But the agency earlier this year mentioned that the shortage of semaglutide is over, blocking the practice in several cases.
Moore told CNBC that “It continues to be alarming and disturbing for us,” citing the addition of illegitimate ingredients that are imported into the U.S. illegally and utilized by some compounding pharmacies to build copycat versions of branded GLP-1s.
As of manufacturing, Moore added that the company is “prepared to be able to satisfy a big demand here in the U.S., and we’re pretty excited about it.” Novo Nordisk asserted that the manufacturing is ongoing at its North Carolina facilities.
