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Company statement
Wed, 04 Feb 2026 11:41:00 -0500
Wed, 04 Feb 2026 11:41:00 -0500
Novo Nordisk introduces Ozempic® Pill; Available in the US Q2 2026
- FDA approves Ozempic® tablets as the proprietary name for the oral semaglutide formulation 1.5 mg, 4 mg, and 9 mg for adults with type 2 diabetes1
- Ozempic® pill offers enhanced bioavailability to achieve comparable therapeutic value as originally approved 3 mg, 7 mg, and 14 mg doses of oral semaglutide1,2
PLAINSBORO, N.J., February 4, 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg. The active ingredient remains the same semaglutide molecule, and the Ozempic® pill is FDA-approved for use in adults with type 2 diabetes to improve blood sugar along with diet and exercise, and to reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events.1 The new Ozempic® name is intended to help patients and health care professionals more easily recognize the available treatment options for type 2 diabetes that contain the semaglutide molecule.
“Because Ozempic® is so well known, people often ask whether there’s an oral option for people with type 2 diabetes, without realizing Rybelsus® has been available since 2019,” said Ed Cinca, Senior Vice President of Marketing & Patient Solutions at Novo Nordisk Inc. “By bringing the oral and injectable options under the Ozempic® name, we’re helping make it clear that both contain semaglutide from Novo Nordisk and are approved to treat type 2 diabetes. The medicine and how it works remain the same; this simply makes the choices clearer to understand. There’s only One Ozempic®…now in two presentations.”
Previously the FDA approved the 1.5 mg, 4 mg, and 9 mg oral semaglutide formulation, now named Ozempic® tablets, based on a bioequivalence study and the clinical trial program for semaglutide tablets at 3 mg, 7 mg, and 14 mg.1,2 The new formulation offers the same efficacy and safety profile as the originally approved formulation.1 With the launch of the Ozempic® pill happening in Q2 2026, patients should continue to take their Rybelsus® medication as prescribed and should not stop treatment without speaking to their health care professionals. Leading up to the launch, Novo Nordisk will share information with patients, caregivers, and health care professionals that will explain what to expect at the pharmacy in Q2 2026.
Novo Nordisk also filed a supplemental drug application for Ozempic® tablets 25 mg for use in adults with type 2 diabetes. The company expects an FDA decision by the end of 2026.
What is Ozempic® tablets?
Ozempic® (semaglutide) tablets 4 mg or 9 mg are a prescription medicine used:
- along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes
- to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes who are at high risk for these events
It is not known if Ozempic® tablets are safe and effective for use in children.
Important Safety Information
What is the most important information I should know about Ozempic® tablets?
Ozempic® tablets 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, Ozempic® tablets and medicines that work like Ozempic® tablets caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® tablets will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
Do not use Ozempic® tablets if:
- you or any of your family have ever had 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 Ozempic® tablets. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic® tablets?”
Before using Ozempic® tablets, 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 a history of vision problems related to your diabetes
- are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
- are pregnant or plan to become pregnant. It is not known if Ozempic® tablets will harm your unborn baby. You should stop using Ozempic® tablets 2 months before you plan to become pregnant
- are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Ozempic® tablets
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ozempic® tablets may affect the way some medicines work, and some medicines may affect the way Ozempic® tablets work.
What are the possible side effects of Ozempic® tablets?
Ozempic® tablets may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Ozempic® tablets 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
- changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Ozempic® tablets
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and 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 Ozempic® tablets. Tell your healthcare provider if you have stomach problems that are severe or will not go away
- serious allergic reactions. Stop using Ozempic® tablets 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
- gallbladder problems. Gallbladder problems have happened in some people who take Ozempic® tablets. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, or clay-colored stools
- food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Ozempic® tablets may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Ozempic® tablets before you are scheduled to have surgery or other procedures
The most common side effects of Ozempic® tablets may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start Ozempic® tablets.
Please click here for Prescribing Information and Medication Guide for Ozempic® (semaglutide) tablets.
About Novo Nordisk
Novo Nordisk is a leading global health care 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 across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington, D.C. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Contacts for further information
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Media: |
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Liz Skrbkova (US) |
Ambre James-Brown (Global)
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Investors: |
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Frederik Taylor Pitter (US) +1 609 613 0568
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Jacob Martin Wiborg Rode (Global)
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Sina Meyer (Global) +45 3079 6656
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Christoffer Sho Togo Tullin (Global)
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Max Ung (Global)
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Alex Bruce (Global) +45 34 44 26 13
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References:
- Ozempic® (semaglutide) tablet [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Nielsen MS, Brøndsted L, Kankam M, et al. A bioequivalence study of two formulations of oral semaglutide in healthy participants. Diabetes Ther. 2025;16(2):269-287. doi:10.1007/s13300-024-01674-8