Newest GLP-1 Medicines: FDA Approvals and Label Changes

Short answer: The newest GLP-1 medicine in the US is Foundayo® (orforglipron), a once-daily tablet approved on April 1, 2026, and the only new molecule in this list. Wegovy® tablets (December 22, 2025) and Ozempic® tablets (a name added to the Rybelsus® label on January 30, 2026) are new forms or names of semaglutide. Since late 2024, labels have also added new uses, new multi-dose pens, and dropped a warning on suicidal thoughts at the FDA’s request. Each line below is tied to a dated FDA or DailyMed record.

What counts as a “new” GLP-1 medicine?

Drugs@FDA, the FDA’s database of approvals, sorts each approval into a type. Those types show that “new” means different things:

Medicine	Approved	Drugs@FDA type	What is new
Foundayo (orforglipron) tablets	April 1, 2026	Type 1, New Molecular Entity	A medicine that was not on the US market before
Wegovy (semaglutide) tablets	December 22, 2025	Type 3, New Dosage Form	A tablet form of a medicine already sold as an injection
Ozempic (semaglutide) tablets	Labeling approval January 30, 2026	Supplement to the Rybelsus application	A second brand name on the semaglutide tablet application

So of the three newest GLP-1 tablets, only Foundayo is a new medicine. The other two contain semaglutide, the medicine in Ozempic injection and Wegovy injection. For how the tablets are taken, see Foundayo: what the label says, Wegovy pill: what the label says and Ozempic pill and Rybelsus.

What has changed since late 2024?

The dates below come from the approval histories on Drugs@FDA and from the “Recent Major Changes” box at the top of each label on DailyMed. They record approvals and label wording, not how well a medicine works for any one person.

Date	Medicine	What changed	Record
December 20, 2024	Zepbound	New use: moderate to severe obstructive sleep apnea in adults with obesity	Drugs@FDA, “Efficacy-New Indication”; label Section 1
January 28, 2025	Ozempic injection	New use: lowering the risk of kidney decline, kidney failure and heart death in adults with type 2 diabetes and chronic kidney disease	Drugs@FDA, “Efficacy-New Indication”; label Section 1
August 15, 2025	Wegovy injection	New use: a liver disease called MASH, without cirrhosis, with moderate to advanced scarring, in adults, under accelerated approval	Drugs@FDA, “Efficacy-New Indication”; label changes dated 08/2025
October 17, 2025	Rybelsus	New use: lowering the risk of major heart events in adults with type 2 diabetes at high risk	Drugs@FDA, “Efficacy-New Indication”; label changes dated 10/2025
December 19, 2025	Mounjaro	New group: children 10 years and older with type 2 diabetes	Drugs@FDA, “Efficacy-New Patient Population”; label changes dated 12/2025
December 22, 2025	Wegovy tablets	New tablet form of Wegovy	Drugs@FDA, original approval
January 13, 2026	Wegovy, Zepbound, Saxenda	FDA asked the makers to remove the warning on suicidal behavior and ideation	FDA Drug Safety Communication; Wegovy and Zepbound labels list the warning as removed in 02/2026
January 20, 2026	Zepbound and Mounjaro	Labeling updates; both labels now include a multi-dose KwikPen and a warning never to share it	Drugs@FDA labeling approvals; Zepbound label dates the KwikPen warning 01/2026
January 30, 2026	Ozempic tablets	Ozempic name added to the Rybelsus tablet application and label	Drugs@FDA labeling approval; DailyMed label effective January 30, 2026
March 19, 2026	Wegovy injection	Approval listed as “Efficacy-New Dosing Regimen”; the current label includes a higher-strength pen called Wegovy HD	Drugs@FDA; label changes dated 03/2026
April 1, 2026	Foundayo	New medicine approved for weight reduction in adults	Drugs@FDA original approval; FDA news release
June 18, 2026	Wegovy	Label adds a warning never to share the multi-dose Wegovy FlexTouch pen	Label changes dated 06/2026; DailyMed label effective June 18, 2026
August 26, 2026	Zepbound	Labeling change with clinical data; a warning on diabetic eye disease in people with type 2 diabetes	Drugs@FDA, “Efficacy-Labeling Change With Clinical Data”; label changes dated 08/2026
August 27, 2026	Mounjaro	New use: lowering the risk of major heart events in adults with type 2 diabetes at high risk	Drugs@FDA, “Efficacy-New Indication”; label changes dated 08/2026

Strengths and new dosing schedules are a prescriber decision, so this page does not cover them. For the full list of GLP-1 medicines by name, form and use, see GLP-1 medications list.

Which new GLP-1 medicines are for weight?

Of the approvals above, two new tablets carry a weight indication:

• Wegovy tablets. The Wegovy label says the tablets are indicated, with a reduced-calorie diet and increased physical activity, “to reduce excess body weight and maintain weight reduction long term” in adults with obesity, or with overweight and at least one weight-related condition, and to lower the risk of major heart events in adults with established heart disease and obesity or overweight.
• Foundayo. The FDA’s announcement describes a once-daily tablet that “does not need to be taken on an empty stomach.” Its label lists one use: weight reduction and long-term maintenance in adults with obesity, or with overweight and at least one weight-related condition.

Ozempic tablets are not a weight medicine. Their label lists blood sugar control and lowering heart-event risk in adults with type 2 diabetes. For tablets next to injections, see GLP-1 pills vs shots.

What happened to the warning about suicidal thoughts?

On January 13, 2026, the FDA published a Drug Safety Communication asking for the removal of the suicidal behavior and ideation warning from three medicines approved for weight: “The affected products are Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide).” The FDA said its review “found no increased risk of SI/B with the use of GLP-1 RA medications,” based on a meta-analysis of 91 placebo-controlled trials with 107,910 patients. It noted that labeling for GLP-1 medicines approved for type 2 diabetes “does not currently include information on the risk of SI/B.”

The current Wegovy and Zepbound labels list the section as removed in February 2026. The FDA’s advice to patients was: “Patients should continue taking their medication as prescribed and discuss any concerns with their health care professionals.” If you notice changes in your mood or thoughts, tell your healthcare provider whether or not a label mentions them.

What changed for Medicare?

Medicare.gov says that starting July 1, 2026, Medicare covers Foundayo (tablet), Wegovy (injection or tablet) and Zepbound (KwikPen only) under the temporary Medicare GLP-1 Bridge, with a $50 monthly copayment for those who qualify. Prior authorization is valid “through December 31, 2027, unless you change GLP-1s.” The rules have eligibility criteria and an end date, so see Does Medicare cover GLP-1 drugs?.

How can you check if your medicine’s label changed?

Labels change several times a year. Three places show it:

• The Medication Guide in your box. The semaglutide tablet guide says to read it “before you start using RYBELSUS or OZEMPIC tablets and each time you get a refill. There may be new information.”
• DailyMed. The top of each prescribing information has a “Recent Major Changes” box listing the sections that changed and the month and year.
• Drugs@FDA. Each application lists its approvals with a date and a category, such as “Efficacy-New Indication” or “Labeling-Medication Guide.”

If your pharmacy hands you a pen or tablet that looks different from your last one, such as a KwikPen in place of single-dose pens, or a round tablet in place of an oval one, ask the pharmacist before you use it. The pens’ instructions differ; see Zepbound pen vs KwikPen and Wegovy pen vs FlexTouch.

What is not on this list?

This page lists only approvals and label changes that appear on FDA and DailyMed pages. Medicines still in clinical trials, applications still under FDA review, and compounded products are not on it. On compounded GLP-1 products, the FDA says it “does not review compounded drugs for safety, effectiveness or quality”; see GLP-1 medications list.

How can you keep track?

When a label, a pen or a tablet changes, a dated note of what you were given and when you started it makes the next appointment easier. Weeko, a shot tracker coming to iPhone and Android, is being built around this kind of simple log. It is a logbook, not medical guidance.

When to call your doctor

Talk to your prescriber before you change from one GLP-1 medicine or form to another, including from an injection to a tablet; the labels have their own switching rules, and Rybelsus and Ozempic tablets “are not substitutable on a mg-to-mg basis.” Ask your pharmacist if a refill looks different from the last one.

The Medication Guides for Foundayo, Wegovy, Ozempic, Rybelsus, Mounjaro and Zepbound each say to stop the medicine and call your healthcare provider right away for severe pain in your stomach area that will not go away, with or without vomiting, and to stop it and get medical help right away for signs of a serious allergic reaction, such as swelling of the face, lips, tongue or throat. Tell your healthcare provider about nausea, vomiting or diarrhea that does not go away, gallbladder symptoms (upper stomach pain, fever, yellowing of the skin or eyes, clay-colored stools), or a lump or swelling in your neck.