GLP-1 FDA Indications Chart: Every FDA-Approved Use, by Drug

You typed “GLP-1 FDA indications chart” because somewhere along the way, the brand names stopped making sense. Ozempic. Wegovy. Mounjaro. Zepbound. Foundayo. Same molecules, different brands, totally different approvals — and somebody (a doctor, a pharmacist, an insurance denial letter) just told you the difference matters.

The master GLP-1 FDA indications chart

Below is every brand-name GLP-1 or GIP/GLP-1 product currently approved by the FDA. Every cell was checked against the drug's current prescribing information at DailyMed or the FDA's own press announcement establishing the indication. Use the filter below to narrow by condition, age range, and form preference.

What GLP-1 medications are FDA-approved right now?

As of May 2026, eleven FDA-approved GLP-1 brand products are actively sold in the United States: nine standalone GLP-1 or dual GIP/GLP-1 brand families — Ozempic, Rybelsus/Ozempic tablets, Wegovy, Mounjaro, Zepbound, Foundayo, Trulicity, Victoza, and Saxenda — plus two GLP-1/insulin fixed-dose combinations (Soliqua and Xultophy). Three older GLP-1s (Adlyxin, Byetta, Bydureon BCise) and one even older drug (Tanzeum) were FDA-approved at one point but have been discontinued.

A few brand families include more than one product:

• Wegovy includes the original injection (up to 2.4 mg), Wegovy HD (7.2 mg injection), and Wegovy tablets (25 mg oral).
• Ozempic includes the original injection (0.5/1/2 mg) and Ozempic tablets (1.5/4/9 mg oral) — the latter introduced as part of Novo Nordisk's transition from the Rybelsus brand in the United States.

The class includes seven distinct molecules:

The first FDA-approved GLP-1 was Byetta (exenatide), approved April 28, 2005. The newest is Foundayo (orforglipron), approved April 1, 2026. See our GLP-1 FDA approvals timeline for the full chronology.

Which GLP-1s are pills, and which are injections?

The FDA-approved oral GLP-1 products are Ozempic tablets, Rybelsus, Wegovy tablets, and Foundayo. Every other active product is an injection. For most of GLP-1 history, the only options were injections. That changed fast between September 2019 (Rybelsus, the first oral GLP-1) and April 2026 (Foundayo, the first non-peptide oral GLP-1).

The oral options

The injection options range from twice daily (Byetta, now discontinued) to daily (Victoza, Saxenda, Soliqua, Xultophy) to once weekly (Ozempic injection, Wegovy injection, Wegovy HD, Mounjaro, Zepbound, Trulicity, plus the discontinued Bydureon BCise).

Which GLP-1s are FDA-approved for type 2 diabetes?

Five standalone GLP-1 or dual GIP/GLP-1 brand families are currently FDA-approved to treat type 2 diabetes in adults: Ozempic injection, Ozempic tablets/Rybelsus, Mounjaro, Trulicity, and Victoza. Three of those — Mounjaro, Trulicity, and Victoza — are also FDA-approved for kids ages 10 and older. Two combination products (Soliqua and Xultophy) are FDA-approved for adults with type 2 diabetes. Wegovy, Zepbound, Saxenda, and Foundayo are not approved for type 2 diabetes, even though some share active ingredients with diabetes-approved drugs.

Adult type 2 diabetes

If your doctor is choosing a GLP-1 for adult type 2 diabetes, the FDA-approved standalone options are:

• Ozempic injection (semaglutide, 0.5/1/2 mg weekly)
• Ozempic tablets (semaglutide, 1.5/4/9 mg daily; the 1.5 mg dose is the recommended starting dose for the first 30 days and is not effective for glycemic control on its own)
• Rybelsus (semaglutide, 3/7/14 mg daily) — same molecule as Ozempic tablets, in a different dose strength set; brand being transitioned to Ozempic tablets in the U.S.
• Mounjaro (tirzepatide, 2.5–15 mg weekly)
• Trulicity (dulaglutide, 0.75–4.5 mg weekly)
• Victoza (liraglutide, up to 1.8 mg daily)

Each is approved as an “adjunct to diet and exercise” — meaning the FDA expects it to be used alongside lifestyle changes, not instead of them.

Pediatric type 2 diabetes (age 10 and up)

This area changed in December 2025. Three GLP-1s are now FDA-approved for kids 10 and older with type 2 diabetes:

• Mounjaro — approved December 2025, based on the SURPASS-PEDS trial. Kids on Mounjaro lowered their A1C by an average of 2.2% over 30 weeks. One detail most charts miss: the pediatric maximum dose is 10 mg weekly, not the 15 mg adult maximum.
• Trulicity — approved for pediatric use in 2022, the first weekly GLP-1 cleared for this age group.
• Victoza — first approved for kids in June 2019. Generic versions from Hikma and Teva are also approved for pediatric T2D.

No GLP-1 is FDA-approved for type 2 diabetes in children younger than 10.

Heart attack and stroke risk reduction (MACE)

Some GLP-1s carry an extra FDA-approved use: reducing the risk of major adverse cardiovascular events — what doctors call MACE (cardiovascular death, non-fatal heart attack, or non-fatal stroke). The populations differ by product:

• Ozempic injection — adults with type 2 diabetes and known heart disease, based on the SUSTAIN-6 trial (26% MACE reduction vs. placebo).
• Ozempic tablets / Rybelsus — adults with type 2 diabetes who are at high risk for these events (a broader label population than the injection's known-heart-disease language).
• Trulicity — adults with type 2 diabetes plus either established cardiovascular disease or multiple cardiovascular risk factors. This is the broadest label of the three — the REWIND trial enrolled people without prior heart disease.
• Victoza — adults with type 2 diabetes and established cardiovascular disease, based on the LEADER trial.

The newer drugs — Mounjaro and Foundayo — do not yet have a MACE indication. Eli Lilly has submitted Mounjaro's SURPASS-CVOT trial data to the FDA. A decision is pending.

Chronic kidney disease in type 2 diabetes

GLP-1 plus insulin combination products

• Soliqua 100/33 — insulin glargine plus lixisenatide. Adults with type 2 diabetes.
• Xultophy 100/3.6 — insulin degludec plus liraglutide. Adults with type 2 diabetes.

These are not the same as taking a standalone GLP-1. They're fixed-dose combos, dosed in units rather than milligrams. Pharmacy benefit forms sometimes lump them with the GLP-1 class, but they're a separate category clinically.

Which GLP-1s are FDA-approved for chronic weight management?

Six FDA-approved GLP-1 products are indicated for chronic weight management in 2026: Wegovy injection, Wegovy HD injection, Wegovy tablets, Zepbound, Saxenda, and Foundayo. Wegovy injection and Saxenda are also approved for adolescents ages 12 and older. Ozempic, Mounjaro, Trulicity, and Victoza are not FDA-approved for weight loss — even though weight loss commonly happens when people take them for diabetes.

Adult chronic weight management — BMI thresholds

To match the FDA-approved population for any weight-management GLP-1, you generally need:

• A BMI of 30 or higher (the FDA's threshold for obesity), or
• A BMI of 27 or higher (called overweight) plus at least one weight-related condition like high blood pressure, high cholesterol, type 2 diabetes, or obstructive sleep apnea.

The six adult weight-management options

Adolescent chronic weight management (age 12 and up)

• Wegovy injection — for kids 12+ with BMI at or above the 95th percentile for their age and sex.
• Saxenda — for kids 12+ with body weight greater than 60 kg (about 132 lb) and obesity by international cut-offs.

No GLP-1 is FDA-approved for weight management in children under 12.

Cardiovascular risk reduction in obesity and overweight

Which GLP-1 is FDA-approved for sleep apnea?

What this approval changes in practice is the prior-authorization question. Zepbound for OSA is an FDA-labeled OSA-in-adults-with-obesity indication, not just a weight-management claim. The relevant ICD-10 code is G47.33. Whether your specific plan covers Zepbound for OSA still depends on your plan's criteria — coverage rules vary by plan and change over time.

The approval was based on the SURMOUNT-OSA trial (469 adults with moderate-to-severe OSA and obesity). After 52 weeks, participants on tirzepatide had a statistically significant reduction in apnea-hypopnea index (AHI) versus placebo. Some achieved remission or mild OSA with resolution of symptoms.

Which GLP-1 is FDA-approved for fatty liver disease (MASH)?

A few important details that most pages miss:

• The approval specifies F2 or F3 fibrosis — the second and third stages on the standard 0-to-4 liver scarring scale. Stage F4 is cirrhosis, which is excluded.
• This is an accelerated approval, meaning the FDA cleared it based on liver-biopsy improvements before the long-term outcomes data is in. Part 2 of the ESSENCE trial is expected to read out around 2029 and will determine whether the approval converts to standard approval.
• The November 2025 update to AASLD practice guidance now recommends semaglutide for MASH patients with F2-F3 fibrosis, identified using non-invasive tests like FibroScan, MR elastography, or the ELF blood test.

In the ESSENCE trial's Part 1, 63% of patients on Wegovy achieved resolution of MASH without worsening of fibrosis, compared to 34% on placebo, at 72 weeks. Fibrosis improvement without worsening of MASH occurred in 37% versus 22%. Average weight loss in the semaglutide arm was 10.5%.

Same active ingredient, different FDA indication — the most common confusion

Three of the major GLP-1 molecules — semaglutide, tirzepatide, and liraglutide — are each sold under two or more brand names with different FDA indications. The molecule does the same thing biologically, but the FDA approves products, not molecules.

• Ozempic is not FDA-approved for weight loss. Many people take it for that anyway, off-label, and lose weight. But the prescription is off-label, and insurance for weight loss reflects that.
• Mounjaro is not FDA-approved for weight loss either. Zepbound is the tirzepatide product for that.
• Wegovy is not FDA-approved for diabetes. Ozempic is the semaglutide product for that.
• The doses are not interchangeable. Wegovy maxes out at 2.4 mg (or 7.2 mg for Wegovy HD). Ozempic maxes out at 2 mg. Rybelsus tops out at 14 mg; Ozempic tablets top out at 9 mg. The labels say Rybelsus and Ozempic tablets are not substitutable on a mg-to-mg basis.

What's new in GLP-1 FDA approvals since 2025?

Between January 2025 and May 2026, the FDA approved or expanded eight major GLP-1 actions. In rough chronological order:

Pending decisions (as of May 12, 2026)

• Mounjaro MACE indication — Eli Lilly submitted based on SURPASS-CVOT, which reported an 8% lower rate of MACE-3 events versus Trulicity. FDA decision pending.
• Foundayo for type 2 diabetes — Eli Lilly has said it plans to submit to the FDA for T2D by the end of Q2 2026.
• Ozempic tablets 25 mg for T2D — Novo Nordisk filed a supplemental application; FDA decision expected by end of 2026.

We'll update this chart the day each one lands.

Which GLP-1s have a generic available?

Two GLP-1 molecules have FDA-approved generics as of May 2026: exenatide and liraglutide. Generic exenatide exists, but its branded reference products (Byetta and Bydureon BCise) have been discontinued. Generic liraglutide is the active generic story:

Which GLP-1s have been discontinued?

Three FDA-approved GLP-1s have been voluntarily discontinued by their makers: Adlyxin (lixisenatide, discontinued January 1, 2023 by Sanofi), Byetta (exenatide, discontinued October 25, 2024 by AstraZeneca), and Bydureon BCise (exenatide extended-release, discontinued October 28, 2024 by AstraZeneca). Tanzeum (albiglutide) was discontinued in 2017. The active ingredient in Adlyxin is still available combined with insulin in Soliqua.

FDA-approved vs. off-label vs. compounded — the categories matter

A drug is FDA-approved when its specific manufacturer has shown the FDA that the product is safe and effective for a specific use in a specific population. An off-label prescription is a legal prescription of an FDA-approved drug for a use the FDA hasn't approved. A compounded drug is one a pharmacy makes individually — these are not FDA-approved at all.

Common compounded GLP-1 claims vs. what the FDA actually says

How to use this chart with your doctor or insurer

This chart is built to answer one question: “What is this product FDA-labeled to do, for which population?” It's not built to tell you which drug is best for you, whether your insurance will cover it, whether your pharmacy stocks it, or whether the dose is right for your situation.

If you're walking into a doctor's appointment with this page open, here's the short checklist:

1. What am I being treated for? Diabetes, weight, heart, kidney, sleep apnea, MASH, or some combination?
2. Which product on this chart is FDA-labeled for that? Cross-check the row.
3. Does my age and population match? Adult, adolescent 12+, child 10+.
4. Does my insurance care about FDA indication or just drug class? Most prior-authorization forms ask for both diagnosis code and drug name. A mismatch is a common cause of denial.
5. Is there a brand of the same molecule that fits my situation better? Someone with both T2D and obesity, for example, may want to discuss Ozempic vs. Wegovy with their doctor.

Sponsored. Affiliate disclosure above.

How we verified every cell in this chart

Every indication on this chart was checked against the current FDA-approved prescribing information at DailyMed or the FDA press announcement that added the indication, and cross-checked against the manufacturer's confirming press release. We did not interpolate from competitor pages or summary articles. Each cell is graded A, B, or C based on the strength of the source.

Our source hierarchy, in order:

1. DailyMed prescribing information (dailymed.nlm.nih.gov). DailyMed contains the labeling submitted to FDA by manufacturers, currently in use. The “Indications and Usage” section is where the FDA-approved indication is officially defined.
2. FDA approval letters and press announcements (fda.gov). Used to confirm dates and the specific indication wording for newly-added uses.
3. Manufacturer prescribing information PDFs (e.g., pi.lilly.com, novo-pi.com). Used when DailyMed has not yet updated for the most recent label change.
4. Manufacturer press releases (PRNewswire archives, investor.lilly.com, novonordisk.com). Used only as supporting evidence and to verify dates.

Verification grades

• ACurrent FDA / DailyMed label text confirmed. The strongest grade. This is most rows.
• BManufacturer prescribing information confirmed, DailyMed cross-check pending. Used briefly when a label change is recent and DailyMed hasn't synced yet.
• CHistorical or discontinued reference only. The drug had FDA approval at some point but is not currently marketed.

We refresh the chart at least monthly and immediately after any FDA action that changes a label. The “Last verified” date at the top of this page is updated every time we re-confirm — not just the first time we published.

Frequently asked questions

Update log

This log shows every change we've made to the chart since the current version was published.

Next refresh target: Mounjaro MACE indication (pending FDA decision), Foundayo type 2 diabetes filing (expected end of Q2 2026), Ozempic tablets 25 mg for T2D (expected end of 2026).

Who created this page

Related guides on The Rx Index

• GLP-1 FDA Approvals Timeline (2005–2026) — full chronological history
• Best GLP-1 for Diabetes — decision guide for type 2 diabetes
• Best GLP-1 for PCOS — off-label conversation for women with PCOS
• Is GLP-1 Safe? The 2026 Safety Guide
• GLP-1 Cost Without Insurance
• Best Brand-Name GLP-1 Providers
• Does FEHB Cover Zepbound? 2026 Plan-by-Plan Guide

Sources cited on this page

This page is a regulatory reference, not medical advice. FDA approvals change. Last verified May 12, 2026. If you're reading this more than 90 days after that date, check the update log above or contact your pharmacist or prescriber for current label information.