FDA-Approved Wegovy Pill Rolls Out Nationwide, Offering Daily Alternative to Weekly Injections

The little white tablet has to be taken first thing in the morning, on an empty stomach, with no more than four ounces of plain water. Then comes a 30-minute wait before breakfast, coffee or any other medicine.

For millions of Americans with obesity, drugmaker Novo Nordisk is betting that ritual will be easier to accept than a weekly injection.

FDA approval and U.S. launch

In late December, the U.S. Food and Drug Administration approved once-daily Wegovy tablets, an oral form of the blockbuster drug semaglutide, as the first glucagon-like peptide-1 (GLP-1) medication in pill form specifically cleared for chronic weight management in adults and for reducing the risk of major cardiovascular events in certain high-risk patients.

On Jan. 5, the Danish company said the pill was now broadly available across America, stocked at more than 70,000 pharmacies and offered through a network of telehealth providers. Novo Nordisk set a self-pay price starting around $149 a month for the lowest dose, with higher doses reaching $299 a month.

The launch marks a new phase in the rapid expansion of GLP-1 drugs, which have transformed obesity and diabetes treatment in recent years. It also raises questions about who will get access to powerful, costly medicines that are increasingly positioned as tools to prevent heart attacks and strokes as much as to help people lose weight.

Who the pill is for

Wegovy tablets are approved for:

• Adults with obesity, defined as a body mass index (BMI) of 30 or higher.
• Adults who are overweight (BMI of at least 27) and have at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol.

The pill is also authorized to reduce the risk of major cardiovascular events—including cardiovascular death, nonfatal heart attack and nonfatal stroke—in adults with established cardiovascular disease who have obesity or are overweight.

The drug must be used along with a reduced-calorie diet and increased physical activity, the FDA said.

Evidence behind the approval

The active ingredient, semaglutide, mimics a natural hormone that helps regulate appetite and blood sugar. Wegovy injections, given once a week, were first approved for weight management in 2021.

In March 2024, the FDA added a cardiovascular indication after a large trial known as SELECT found that injectable semaglutide cut the risk of major cardiovascular events by about 20% in more than 17,000 adults with overweight or obesity and established heart disease.

“In the United States, the majority of adults have overweight or obesity, which can increase the risk of serious health problems, including heart disease,” Dr. John Sharretts, a senior official in the FDA’s Center for Drug Evaluation and Research, said when that decision was announced.

The new oral version extends that positioning to a daily pill.

In Novo Nordisk’s phase 3 OASIS-4 trial, which supported the tablet’s approval, adults with obesity or overweight and at least one weight-related condition but without diabetes took semaglutide tablets for 64 weeks. Among those who remained on treatment, people on the drug lost an average of about 17% of their body weight, compared with about 3% for those on placebo. When all enrolled participants were counted, including those who stopped taking the medicine, average weight loss was roughly 14% on the drug versus 2% on placebo.

Company executives have emphasized that no other oral GLP-1 obesity candidate has matched that degree of weight loss in late-stage trials.

“Wegovy pill is the next chapter in our decades-long GLP-1 experience,” Dave Moore, executive vice president for U.S. operations at Novo Nordisk, said in a statement about the approval. He called it “supported by the most affordable self-pay price to date in a GLP-1 for obesity.”

Dosing and side effects

The tablets are available in 1.5-, 4-, 9- and 25-milligram strengths. Patients typically start at 1.5 milligrams once daily and increase the dose every month over 90 days until they reach 25 milligrams, which is the target long-term dose for most people. If patients cannot tolerate the highest oral dose, prescribing information suggests switching to the injectable version rather than staying on a lower pill dose indefinitely.

Like other drugs in its class, the Wegovy pill carries a boxed warning for possible thyroid C-cell tumors, including medullary thyroid carcinoma. It should not be used in people with a personal or family history of that cancer or in those with multiple endocrine neoplasia syndrome type 2. The label also cautions about pancreatitis, gallbladder disease, acute kidney injury, increased heart rate, and suicidal thoughts or behavior.

Gastrointestinal side effects are common. In the pivotal trial, nausea, vomiting and diarrhea were reported in roughly three-quarters of patients taking the drug, compared with about 40% on placebo. Most events were described as mild to moderate.

Convenience—at a cost of strict instructions

The convenience of a pill may be offset by the strict dosing regimen. It must be swallowed whole in the morning with a small amount of water and nothing else, and patients are told to wait at least 30 minutes before eating, drinking other liquids or taking any additional oral medication. That regimen may be challenging for people who take multiple morning prescriptions or have irregular schedules.

Pricing, access, and the insurance divide

The commercial rollout shows how quickly the GLP-1 market has shifted toward direct-to-consumer channels. Wegovy tablets are being sold through major pharmacy chains such as CVS and Costco and through online providers such as Ro, LifeMD and WeightWatchers’ clinical arm. Many offer virtual consultations and mail-order delivery.

Novo Nordisk said some privately insured patients could pay as little as $25 a month using manufacturer savings offers. For those paying cash, the introductory $149 monthly price applies to the lowest dose; higher daily doses are priced at $199 or $299 a month in most programs, with some promotional discounts.

Those prices are far below the list price of injectable Wegovy, which is around $1,349 for a month’s supply. But obesity experts note that even $149 a month is beyond reach for many people without robust insurance coverage.

More than 40% of U.S. adults had obesity in the years leading up to the COVID-19 pandemic, according to the Centers for Disease Control and Prevention. Rates are highest among some racial and ethnic minorities and people with lower incomes—groups that also face greater barriers to specialty care and to newer, brand-name medicines.

Medicare prescription drug plans have historically been barred from covering medications prescribed solely for weight loss. Lawmakers have repeatedly proposed expanding coverage for obesity treatment, but Congress has not passed a change. Insurers and large employers vary widely in whether they cover GLP-1 drugs for weight management, often imposing strict eligibility criteria or prior authorization.

Supporters of broader coverage argue that GLP-1 medicines should be seen as cardiovascular treatments, not cosmetic aids, especially now that Wegovy in both injectable and oral forms carries a label for reducing major heart problems in high-risk patients. Payers worry about the immediate impact on drug budgets if large numbers of people start therapy and stay on it for years.

Competition is intensifying

The new pill also lands in a fiercely competitive market. Eli Lilly’s Zepbound injection, which uses the dual-action drug tirzepatide, was approved for weight management in 2023 and has shown average weight loss of around 20% at higher doses in trials. Lilly is also developing its own oral GLP-1 drug, orforglipron, with a U.S. regulatory decision expected this year.

Analysts expect Novo Nordisk’s tablet to generate significant sales while giving the company a first-mover advantage in obesity-focused oral GLP-1 therapy and a new way to reach patients who were reluctant to start injections.

What comes next

For patients, doctors and insurers, the arrival of Wegovy in pill form adds another powerful option—and another set of decisions. The evidence suggests that as long as people stay on semaglutide, they can lose a substantial share of body weight and, for those with heart disease, lower their risk of heart attack and stroke. Stopping the drug, however, is often followed by weight regain.

As more oral obesity drugs reach the market and prices continue to evolve, the question will be not only how many Americans can take a daily GLP-1 pill, but how many can keep taking it long enough to change the course of their health.