FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults

• Average weight loss of ~17% if all patients stayed on treatment^* with Wegovy^® (semaglutide) tablets 25 mg (~14% regardless of if patients stayed on treatment^**) in the OASIS 4 trial¹
• 1.5 mg starting dose available in early January for $149 per month with savings offers; Wegovy^® pill is being produced in the US and robust supply is on-hand
• Wegovy^® brand is the only GLP-1 indicated for weight loss proven to help prevent life-threatening CV events for adults with established CVD and either overweight or obesity along with diet and exercise; Wegovy^® has been prescribed for approximately 3.2 million people in the US^2-4

PLAINSBORO, N.J., Dec. 22, 2025 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved once-daily Wegovy^® pill, the first oral GLP-1 medicine for obesity in the US.³ Wegovy^® pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off.³ Wegovy^® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.³

"The launch of Wegovy^® in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy^® pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. We are confident that the expansion of Wegovy^® to a pill will help patients who may have not sought or accepted treatment before," said Dave Moore, executive vice president, US Operations at Novo Nordisk. "Wegovy^® pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities."

The FDA approval of Wegovy^® pill is based on the results from the OASIS 4 phase 3 clinical trial, which was a 64-week medical study that included 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes.¹

Results showed that if all patients stayed on treatment, people taking Wegovy^® pill once-daily along with a reduced calorie diet and exercise achieved an average weight loss of about 17% (16.6%) versus about 3% (2.7%) with placebo.^*1 When looking at the efficacy regardless of if all patients stayed on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking Wegovy^® pill compared to about 2% (2.4%) for placebo.^**1  

 

In OASIS 4, common adverse reactions were similar to those previously seen in clinical trials with Wegovy^® (semaglutide) injection 2.4 mg, including nausea, diarrhea, and vomiting.¹

"With more choices, HCPs are better equipped to tailor treatment approaches and support patients who want to gain control of their weight, and this milestone approval underscores exactly that kind of choice," explained Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. "The availability of Wegovy^® pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery, allowing the ability to help meet more patients where they are."

The starting dose of 1.5 mg will be available in pharmacies and select telehealth providers in early January with savings offers for just $149 per month. Additional information on coverage and savings options for eligible patients, including other programs designed to help reduce out-of-pocket costs, will also be available at that time.

"After many years advocating for people living with obesity, one thing has always been clear: patient safety has to come first. That's why it's critical we rely on treatments that are rigorously tested and FDA-approved," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1 treatment that can fit in their daily routine and preferences." 

Wegovy^® pill is only approved in the US. Novo Nordisk expects to launch Wegovy^® pill in early January 2026.

^* Based on the trial product estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies.

^** Based on the treatment policy estimand: treatment effect regardless of if patients stayed on treatment or took other weight loss therapies.

About OASIS 4

OASIS 4 was a 64-week phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with one or more weight-related comorbidities.¹ People with diabetes were excluded.¹ OASIS 4 included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.¹

In total, 307 participants were randomized in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks.¹

For those taking Wegovy^® pill, 76% achieved 5% or greater body weight loss (from a baseline body weight of 235 lb.) versus 31% taking placebo (from a baseline body weight of 231 lb.).¹

About obesity 

Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.^5-7 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.^5,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.^8,9

What is Wegovy^®?

Wegovy^® (semaglutide) injection 1.7 mg or 2.4 mg and Wegovy^® (semaglutide) tablets 25 mg are prescription medicines used with a reduced calorie diet and increased physical activity to:

• reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.
• help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off.

Wegovy^® (semaglutide) injection 1.7 mg or 2.4 mg is used with a reduced-calorie diet and increased physical activity to help children 12 years and older with obesity to lose weight and keep the weight off

Wegovy^® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

It is not known if Wegovy^® injection is safe and effective:

• to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in people under 18 years
• to help children under 12 years of age lose weight and keep the weight off

It is not known if Wegovy^® tablets are safe and effective for use in people under 18 years of age.

 

Important Safety Information

What is the most important information I should know about Wegovy^®?

Wegovy^® may cause serious side effects, including:

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy^® and medicines that work like Wegovy^® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
• Do not use Wegovy^® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

 

Do not use Wegovy^® if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy^® injection or Wegovy^® tablets. See symptoms of serious allergic reaction in "What are the possible side effects of Wegovy^®?" 

Before using Wegovy^®, tell your healthcare provider if you have any other medical conditions, including if you:

• have or have had problems with your pancreas or kidneys
• have type 2 diabetes and a history of diabetic retinopathy
• have or have had depression, suicidal thoughts, or mental health issues
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• are pregnant or plan to become pregnant. Wegovy^® may harm your unborn baby. You should stop using Wegovy^® 2 months before you plan to become pregnant
• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Wegovy^® tablets. It is not known if Wegovy^® when received through an injection passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy^® may affect the way some medicines work and some medicines may affect the way Wegovy^® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Wegovy^®?

Wegovy^® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Wegovy^® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back
• gallbladder problems. Wegovy^® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools
• increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy^®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery
• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away
• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy^®. Tell your healthcare provider if you have stomach problems that are severe or will not go away
• serious allergic reactions. Stop using Wegovy^® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
• change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy^®
• increased heart rate. Wegovy^® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes
• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you
• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy^® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy^® before you are scheduled to have surgery or other procedures

The most common side effects of Wegovy^® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.

Please click here for Prescribing Information including Boxed Warning and Medication Guide for Wegovy^®. 

About Novo Nordisk

Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.

 

References:

1. Wharton S, Lingvay I, Bogdanski P, et al. Oral semaglutide 25 mg in adults with overweight or obesity. N Engl J Med. 2025; 393:1077-1087. DOI: 10.1056/NEJMoa2500969.
2. Novo Nordisk A/S. Data on file.
3. Wegovy^® (semaglutide) Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; 2025.
4. Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389:2221-2232.
5. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61–69.
6. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715–723.
7. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1–203.
8. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: December 2025. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
9. Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: December 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.

© 2025 Novo Nordisk All rights reserved. US25SEMO02580 December 2025

 

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