Novo Nordisk has announced the availability of an oral tablet version of Ozempic, a widely prescribed GLP-1 medication, for adults with type 2 diabetes in the United States. The new formulation became available on May 4, 2024.
The Ozempic oral tablet is a reformulation of the company’s existing Rybelsus daily oral medication, which was approved by the FDA in 2019 in 3 mg, 7 mg, and 14 mg doses. The new Ozempic pill comes in lower doses of 1.5 mg, 4 mg, and 9 mg, delivering the same efficacy and safety profile as the original formulation.
Novo Nordisk states that the oral Ozempic pill provides patients with an alternative to the weekly injectable version of the drug. Ozempic is also commonly prescribed off-label for weight loss.
Oral Ozempic vs. Rybelsus: Key Differences
- The Ozempic oral tablet replaces Rybelsus, which was previously the only oral GLP-1 medication from Novo Nordisk.
- The new formulation offers lower doses (1.5 mg, 4 mg, 9 mg) compared to Rybelsus (3 mg, 7 mg, 14 mg).
- Both formulations contain the same active ingredient, semaglutide.
Other GLP-1 Medications Approved in Pill Form in 2024
This marks the third GLP-1 medication approved in pill form this year:
- January 2024: The FDA approved Novo Nordisk’s Wegovy oral tablet for weight management.
- April 2024: The FDA approved Eli Lilly’s Foundayo oral tablet for weight management, though the agency ordered further studies on potential heart, liver, and other risks.
Future Developments for Ozempic Oral Tablet
Novo Nordisk has announced that federal regulators are expected to decide on a 25-mg dose of the Ozempic oral tablet by the end of 2026.
Expert Reactions to the New Ozempic Pill
“With an updated formulation and new branding, oral semaglutide, now under the Ozempic name, helps patients and healthcare professionals more easily recognize the available FDA-approved treatment options for type 2 diabetes that contain the semaglutide molecule.”
“A lot of people are needle-averse. Over the long term, a lot of people get tired of poking themselves.”
The availability of an oral Ozempic pill provides patients with more flexibility in managing their treatment.”
Related articles
GLP-1 Drugs Linked to Better Breast Cancer Outcomes in Obesity and Diabetes Patients
A recent study shows that GLP-1 drugs may help improve survival rates in people with breast cancer, obesity, and diabetes. Image Credit: Tatsiana Volk...
U.S. Pressures Germany on Drug Prices Amid FDA Restructuring Concerns
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about we...
Mail-Order Abortion Pills Remain Legal Amid Legal Uncertainty
In a discussion about the best fruits, my STAT colleague Alexa Lee and I agreed that peaches have been mid in recent years. Is this just a New York Ci...
FDA Rejects Melanoma Drug RP1 Amid Leadership Controversy Under Makary
The FDA’s recent decision to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat melanoma and patients who saw th...
Dr. Makary's Exit and the Future of Cassidy's Senate Seat: Key Health Policy Shifts
This week’s episode of “The Readout LOUD” is all about health politics. We bring on FDA reporter Lizzy Lawrence to discuss Makary’s departure — why he...
Who Will Lead the FDA Next? The Search for a New Commissioner Heats Up
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to...
BeOne Secures FDA Approval for Novel Lymphoma Cell Therapy, Advancing Autoimmune Treatment Pipeline
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Biotech’s cell therapy boo...
Science-Backed: 8,500 Steps Daily for Sustainable Weight Loss
A new study demonstrates that 8,500 daily steps is the sweet spot for weight management. Stewart Cohen/Getty Images Walking 8,500 steps per day can he...