Part of: GLP-1 Weight Loss: The Complete Guide · The basics

Which GLP-1 Medications Are FDA-Approved for Weight Loss? (2026 Guide)

Which GLP-1 drugs are actually FDA-approved for weight loss in 2026, which are diabetes-only, how the pills differ from the shots, and why compounded versions aren't approved.

By Weightomics Editorial TeamEditorial team
Last updated 11 min read

“Is it approved?” is the single most important question to ask about any weight-loss medication. Yet it is surprisingly hard to answer, because the same active ingredient can be sold under several brand names, each approved for different conditions. Add compounded versions, pills, “research peptides” and new 2026 approvals, and it is easy to get confused.

This guide lays out exactly which GLP-1-based medications are FDA-approved for weight management in the United States as of October 2026, which are approved only for type 2 diabetes, and what “approved” actually means for you.

Note: Approvals and labels change. This article reflects official sources we reviewed in October 2026. It is educational only and not medical advice; a licensed clinician decides what is appropriate for an individual patient.

The quick list

FDA-approved GLP-1-based medicines for chronic weight management (adults):

  1. Wegovy (semaglutide), weekly injection, including the higher-strength Wegovy HD 7.2 mg
  2. Wegovy pill (oral semaglutide 25 mg), once daily, approved December 22, 2025
  3. Zepbound (tirzepatide), weekly injection, a dual GIP/GLP-1 receptor agonist
  4. Saxenda (liraglutide) and generic liraglutide, daily injection
  5. Foundayo (orforglipron), once-daily pill, approved April 1, 2026

GLP-1 medicines approved for type 2 diabetes, not weight management:

  • Ozempic (semaglutide injection)
  • Rybelsus and Ozempic tablets (oral semaglutide)
  • Mounjaro (tirzepatide)
  • Trulicity (dulaglutide)
  • Victoza (liraglutide)

If you are new to the topic, start with our explainer what is a GLP-1 medication? and then come back here.

What “FDA-approved for weight loss” really means

The FDA approves a specific product for a specific use (called an indication) at specific doses, based on clinical trials. For weight-management GLP-1s, the indication language is similar across products. The FDA’s 2026 announcement for Foundayo, for example, describes approval “in combination 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 adults with overweight in the presence of at least one weight-related comorbid condition.”

Three things follow from that wording:

  • It’s for adults with obesity or overweight plus a condition. The NIH translates this to a BMI of 30 or more, or 27 or more with a weight-related problem such as high blood pressure or type 2 diabetes.
  • It’s an add-on to lifestyle changes, not a replacement.
  • It’s for long-term use. The NIH notes you can keep taking these medications as long as you are benefiting and not having serious side effects.

When a clinician prescribes a drug for something outside its label, such as a diabetes-only product for weight loss, that is off-label use. It is legal and sometimes reasonable, but the NIH encourages patients to ask openly whether a medication is being used off-label and why.

The approved options, one by one

Wegovy (semaglutide injection)

Wegovy was the first once-weekly GLP-1 approved for chronic weight management, in 2021. Its approval rested largely on the STEP program. In STEP 1, adults without diabetes lost an average of 14.9% of body weight over 68 weeks on semaglutide 2.4 mg, compared with 2.4% on placebo.

Beyond weight, Novo Nordisk’s 2025 SEC filing notes Wegovy is FDA-approved “to reduce the risk of major adverse cardiovascular events, such as death, heart attack or stroke in adults with known heart disease and either obesity or overweight.” NIDDK lists it as approved for adults and children 12 and older.

The NovoCare pharmacy listing (October 2026) shows Wegovy injection doses of 0.25, 0.5, 1, 1.7 and 2.4 mg, plus Wegovy HD 7.2 mg, a higher-strength option. Your clinician sets the dose; labels describe a gradual step-up to reduce side effects.

Wegovy pill (oral semaglutide 25 mg)

On December 22, 2025, the FDA approved the Wegovy pill, which Novo Nordisk described as “the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management.” Its approval was based on the OASIS trial program; the company reported a 16.6% mean weight loss in OASIS 4.

The pill comes with strict instructions for absorption: it is taken in the morning on an empty stomach with a small amount of plain water, followed by a waiting period before eating, drinking or taking other oral medicines. Those details are in the label and are important to follow exactly. Like the injection, it carries a heart-risk reduction indication.

Zepbound (tirzepatide)

Zepbound contains tirzepatide, which acts on both GLP-1 and GIP receptors. In the SURMOUNT-1 trial, adults without diabetes lost an average of 15.0%, 19.5% and 20.9% of body weight at the 5, 10 and 15 mg doses over 72 weeks, versus 3.1% with placebo. Half or more of participants on the 10 and 15 mg doses lost at least 20%.

NIDDK lists Zepbound as approved for adults. It is also approved for moderate-to-severe obstructive sleep apnea in adults with obesity. Its diabetes counterpart, Mounjaro, contains the same molecule.

For a detailed head-to-head, see our semaglutide vs tirzepatide guide.

Saxenda and generic liraglutide

Liraglutide is an older, daily GLP-1 injection. NIDDK lists liraglutide (Saxenda) as approved for adults and children 12 and older. At a lower dose and under the name Victoza, the same drug is approved for type 2 diabetes. Average weight loss in liraglutide trials has been smaller than with semaglutide or tirzepatide; the STEP 1 authors cited a placebo-corrected loss of about 4.5% for liraglutide 3.0 mg in the SCALE trial, while cautioning that cross-trial comparisons are limited. Generic liraglutide has made it a lower-cost option in some situations.

Foundayo (orforglipron)

Foundayo is the newest entry, approved on April 1, 2026. It is a small-molecule GLP-1 receptor agonist taken as a once-daily tablet. The FDA said it was the first new molecular entity approved under the Commissioner’s National Priority Voucher pilot, issued 50 days after filing.

Key differences from the Wegovy pill: the FDA’s acting drug-center director noted it “does not need to be taken on an empty stomach.” According to the FDA, it starts at 0.8 mg and is stepped up at intervals of at least 30 days, with a maximum of 17.2 mg once daily. Its label carries the same type of thyroid C-cell tumor warning and the same restriction for people with a personal or family history of medullary thyroid carcinoma or MEN 2.

Side-by-side comparison

Medicine Ingredient Form Frequency Weight-management approval Other approved uses
Wegovy / Wegovy HD Semaglutide Injection Weekly Adults; 12+ (Wegovy) Heart-risk reduction
Wegovy pill Semaglutide Tablet Daily, empty stomach Adults Heart-risk reduction
Zepbound Tirzepatide Injection Weekly Adults Obstructive sleep apnea with obesity
Saxenda / generics Liraglutide Injection Daily Adults; 12+ —
Foundayo Orforglipron Tablet Daily, with or without food Adults —

Trial results in this article come from different studies with different populations and durations, so they should not be treated as a direct ranking.

Non-GLP-1 weight-loss medications

GLP-1s are not the only approved options. NIDDK also lists orlistat (Xenical, and over-the-counter Alli), phentermine-topiramate (Qsymia) and naltrexone-bupropion (Contrave) as approved for long-term use, plus setmelanotide (Imcivree) for specific rare genetic conditions. Some appetite suppressants like phentermine are approved only for short-term use. These can be relevant for people who cannot take, tolerate or afford a GLP-1, and they have their own risks and restrictions.

Why compounded GLP-1s are not “approved”

During shortages, compounding pharmacies made their own versions of semaglutide and tirzepatide. The FDA is direct about the status of these products: “compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.”

The FDA has raised several concerns:

  • Dosing errors, including adverse events requiring hospitalization linked to people measuring compounded semaglutide incorrectly.
  • Salt forms such as semaglutide sodium or acetate, which are different active ingredients than in the approved drugs and for which the FDA is “not aware of any lawful basis” for use in compounding.
  • Fraudulent labels naming pharmacies that did not actually make the product.
  • Shipping problems, with injectable products arriving warm.
  • “Research use only” products containing semaglutide, tirzepatide, retatrutide and others, sold directly to consumers. The FDA urges people not to buy them.

As of May 31, 2026, the FDA said it had received 990 adverse event reports associated with compounded semaglutide and more than 730 with compounded tirzepatide, and it notes these are likely underreported.

The FDA’s guidance for consumers is to get a prescription from a licensed clinician and fill it at a state-licensed pharmacy. Its BeSafeRx campaign has more information on buying medicines online safely.

What about drugs still in development?

Several newer agents are in late-stage trials or under review, including combinations that add other gut-hormone signals. Until the FDA approves them, they are investigational. The FDA specifically notes that retatrutide and cagrilintide “cannot be used in compounding under federal law” and “have not been found safe and effective for any condition.” Products marketed with those names outside of clinical trials should be treated as a red flag.

We cover the pipeline in our oral and new GLP-1s hub.

How to choose among approved options

There is no single “best” GLP-1. NIDDK lists the factors you and your clinician should weigh:

  • the likely benefits of weight loss for you,
  • possible side effects,
  • your current health issues and other medications,
  • your family medical history, and
  • cost.

Practical questions also matter. Would you rather take a weekly shot or a daily pill? Can you follow the Wegovy pill’s empty-stomach routine every morning? Does your insurance cover one product but not another? See our GLP-1 cost guide and semaglutide cost without insurance for current numbers.

Safety basics that apply to all of them

Whatever product you are considering, a few safety points are common across the GLP-1 class:

  • Digestive side effects are common, especially during dose increases. Read GLP-1 nausea: why it happens and how to manage it.
  • Thyroid warning: not used in people with a personal or family history of MTC or MEN 2.
  • Pregnancy: NIH guidance says weight-loss medications should not be used during pregnancy or when planning one.
  • Do not combine GLP-1s. The Foundayo label, for example, says using it with another GLP-1 receptor agonist is not recommended.
  • Protect your muscle and nutrition with enough protein and strength training; see how much protein you need on a GLP-1.

How “approval” shows up on the pharmacy shelf

When your prescription is filled, the bottle or box will show the brand or generic name of the specific product, not the shorthand “GLP-1.” That is why it is worth reading the label. A box that says Wegovy is the weight-management product. A box that says Ozempic is the diabetes product, even though both contain semaglutide. The same distinction applies to Zepbound versus Mounjaro, and Saxenda versus Victoza.

Ask the pharmacy three practical questions:

  1. Is this the exact product my clinician prescribed?
  2. Is this from an FDA-approved manufacturer (not a compounded version)?
  3. What storage instructions apply, and what should I do if a refrigerated product arrives warm?

Those questions take a minute and prevent many of the problems the FDA has documented with unapproved products.

Adolescents and approvals

Not every product is approved for teenagers. According to NIDDK, the FDA has approved four weight-management medications for children ages 12 and older: orlistat, liraglutide (Saxenda), phentermine-topiramate (Qsymia) and semaglutide (Wegovy). A fifth, setmelanotide, is approved for ages 6 and older with specific rare genetic conditions. Zepbound and the newer pills are approved for adults. Pediatric treatment decisions should involve a pediatric specialist.

How to verify an approval yourself

You do not have to take a website’s word for it, including ours. Three free tools:

  1. Drugs@FDA lists approved products, approval letters and labels.
  2. DailyMed (from the National Library of Medicine) hosts current prescribing information and medication guides.
  3. The FDA’s BeSafeRx pages explain how to identify legitimate online pharmacies.

When you look up a product, read the first section of the label, “Indications and Usage.” It tells you exactly what the product is approved to treat, and for whom.

Why this list will keep changing

The GLP-1 field is moving quickly. In less than a year the US gained an oral Wegovy product and Foundayo. Pipeline drugs that target more than one gut-hormone receptor may arrive later. Each new approval will have its own label, age range, boxed warnings and dosing schedule. Bookmark this page and our oral and new GLP-1s hub, and always cross-check the current FDA label before making a decision.

The bottom line

In 2026, Americans have more FDA-approved GLP-1 weight-management options than ever: Wegovy in injection, high-dose and pill forms, Zepbound, liraglutide and the new Foundayo pill. Popular names like Ozempic and Mounjaro are approved for type 2 diabetes, not weight management, even though they share ingredients with approved weight-loss products. Compounded and “research” versions are not FDA-approved.

The right choice depends on your health, preferences and budget, and it should be made with a licensed clinician. Continue exploring in our GLP-1 Guide hub and the first 30 days guide.

Medical disclaimer: Weightomics publishes general health information for education only. It is not a substitute for professional medical advice, diagnosis or treatment. Never start, stop or change a medication without talking to a licensed clinician.

Frequently asked questions

Is Ozempic FDA-approved for weight loss?

No. Ozempic is FDA-approved for type 2 diabetes (and related heart and kidney risk reduction in some patients). The same active ingredient, semaglutide, is approved for chronic weight management as Wegovy. Prescribing Ozempic for weight loss is off-label.

Is there an FDA-approved GLP-1 pill for weight loss?

Yes. The Wegovy pill (oral semaglutide 25 mg) was approved on December 22, 2025, and Foundayo (orforglipron) on April 1, 2026. The Wegovy pill has strict empty-stomach rules; Foundayo can be taken with or without food.

Is Mounjaro approved for weight loss in the US?

No. In the US, Mounjaro is approved for type 2 diabetes. Tirzepatide is approved for weight management under the name Zepbound.

Are compounded GLP-1s FDA-approved?

No. The FDA states compounded drugs are not reviewed for safety, effectiveness or quality before they are marketed, and should only be used when a patient's needs can't be met by an approved drug.

Who is eligible for FDA-approved GLP-1 weight-loss drugs?

The labels cover adults with obesity (BMI 30 or more) or overweight (BMI 27 or more) with at least one weight-related condition, used with a reduced-calorie diet and more physical activity. Some products are also approved for adolescents 12 and older.

Sources

  1. NIDDK (NIH): Prescription Medications to Treat Overweight & Obesity
  2. FDA: FDA Approves First New Molecular Entity Under National Priority Voucher Program (Foundayo)
  3. Foundayo (orforglipron) prescribing information, FDA
  4. Novo Nordisk Form 6-K (SEC): Wegovy pill approved in the US, December 2025
  5. Wilding JPH et al. STEP 1 trial. N Engl J Med 2021
  6. Jastreboff AM et al. SURMOUNT-1 trial. N Engl J Med 2022
  7. FDA: Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
  8. NovoCare Pharmacy: Wegovy and Ozempic product and dose listing

Keep reading in GLP-1 Guide

See the full GLP-1 Guide hub →

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