Is semaglutide FDA-approved for weight loss?

Which semaglutide products are FDA-approved, and for what?

Semaglutide products are sold under three brand names: Ozempic, Wegovy and Rybelsus. Semaglutide is the active ingredient in Wegovy, Ozempic and Rybelsus, which are covered by three FDA prescribing information documents: one for Wegovy injection and Wegovy tablets, one for Ozempic injection, and one for Rybelsus tablets and Ozempic tablets. [1][2][3]

The FDA status table lists each semaglutide product with its route and the uses in its prescribing information.

FDA's shortage and discontinuation data list Rybelsus tablets as 'To Be Discontinued' (posted June 4, 2026).

What does "FDA-approved" mean for a medicine like semaglutide?

How FDA drug approval works in general is explained on a separate page.

• How FDA drug approval works →

Which semaglutide products are approved for weight management?

Approved uses differ by semaglutide product. One brand name can cover more than one semaglutide product, such as an injection and a tablet, and approved uses differ by product.

Ozempic injection, Ozempic tablets and Rybelsus tablets are not FDA-approved for weight management. Their approved uses are listed in the FDA status table. Prescribing them for weight management is off-label. For weight management in certain people, together with a reduced-calorie diet and more physical activity, FDA has approved Wegovy injection, given under the skin, and Wegovy tablets, taken by mouth.

Our semaglutide products compared page sets out each injection and tablet side by side.

Is there a semaglutide pill for weight loss?

Semaglutide tablets are sold under more than one brand name, and approved uses differ by tablet product. Wegovy tablets, Ozempic tablets and Rybelsus tablets are different semaglutide tablet products. Wegovy tablets are a once-daily pill form of semaglutide, the same medicine that is in Wegovy injection, which is given once weekly. [1]

Semaglutide tablets appear on two separate FDA prescribing information documents: one for Wegovy tablets, which also covers Wegovy injection, and one for Rybelsus tablets and Ozempic tablets. [1][3] Ozempic tablets and Wegovy tablets are different products on different labels, even though both come in 1.5 mg, 4 mg and 9 mg strengths. [3][1]

More detail on the tablets is on our page about Wegovy tablets (oral semaglutide).

Is semaglutide FDA-approved for anti-aging or longevity?

FDA has approved specific semaglutide products only for specific uses, which differ by product, and has not approved any semaglutide product for anti-aging or longevity (checked September 27, 2026).

Semaglutide is not FDA-approved for anti-aging, longevity or general wellness. FDA has approved specific semaglutide products only for specific uses: Ozempic injection, Ozempic tablets and Rybelsus tablets for uses in adults with type 2 diabetes, and Wegovy injection and Wegovy tablets for lowering cardiovascular risk in adults with established cardiovascular disease and obesity or overweight, and for weight management in certain people (plus, for Wegovy injection only, MASH under accelerated approval). Using semaglutide for anti-aging or longevity is off-label. FDA has not reviewed whether it is safe and effective for that purpose.

Researchers are studying whether semaglutide affects aging, and in searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, the human results we found were analyses of lab markers of biological age (the peer-reviewed ones post hoc), which do not show how long or how well people live. [4][5] In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no randomized trial with peer-reviewed or registry results from a planned test of whether semaglutide slows aging in people.

In searches of ClinicalTrials.gov, PubMed and Europe PMC on October 1, 2026, we found three registered randomized trials that include semaglutide and whose registry record or published protocol names markers of aging among the primary outcomes. [6][7][8][9] All three are small: one plans 66 adults with obesity, one plans 30 postmenopausal women aged 46 to 60 with obesity, and one, now complete, enrolled 20 adults aged 65 or older with prediabetes or type 2 diabetes. [6][7][8] All three trials are registered; none has reported results for its aging markers in ClinicalTrials.gov, PubMed or Europe PMC as of October 1, 2026, and the one completed trial has posted a single result, a change in lean body mass. [8]

What the research shows about semaglutide and longevity is on a separate page.

• See what the evidence shows on semaglutide and longevity →

Is compounded semaglutide FDA-approved?

Compounded semaglutide is a different product from Wegovy, Ozempic and Rybelsus.

On its page 'FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss' (FDA page content current as of October 1, 2026), FDA says that, as of May 31, 2026, it had received '990 reports of adverse events associated with compounded semaglutide.' FDA adds: 'It is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events.' FDA also says that federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA, 'so it is likely that adverse events from compounded versions of these drugs are underreported.' FDA further says: 'Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.'

Compounded semaglutide is not FDA-approved. FDA states: 'Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.' FDA determined that the shortage of semaglutide injection products was resolved on February 21, 2025, and said on April 1, 2026 that semaglutide was not on its drug shortage list.

Is there a pending decision on compounded semaglutide?

In a Federal Register notice published May 1, 2026, FDA proposed not to include semaglutide on the list of bulk drug substances that outsourcing facilities may use in compounding (the 503B Bulks List). As of October 1, 2026, we have not found a final decision.

Do you need a prescription for semaglutide?

A licensed clinician decides whether semaglutide is appropriate for a specific person after reviewing their health history.

Each semaglutide product in the FDA status table is available only with a prescription (checked September 27, 2026).

Completing an intake form or making a payment does not guarantee a prescription.

Regulatory status checked September 27, 2026. Sources: www.accessdata.fda.gov/…/209637s038lbl.pdf; www.accessdata.fda.gov/…/213051Orig1s030lbl.pdf; www.accessdata.fda.gov/…/215256s025lbl.pdf; www.fda.gov/…/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize; public-inspection.federalregister.gov/…/2026-12937.pdf; www.fda.gov/…/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list; www.fda.gov/…/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss; www.fda.gov/…/compounding-and-fda-questions-and-answers; www.accessdata.fda.gov/…/218316Orig1s000ltr.pdf; www.accessdata.fda.gov/…/218316s007lbl.pdf

What this means if you're considering semaglutide

Approved uses differ by semaglutide product. Whether a product is appropriate for a specific person is decided by a licensed clinician using that product's prescribing information. Trial results are on the semaglutide for weight loss overview, and label safety information is on the semaglutide side effects page.

Compounded semaglutide is not FDA-approved. See FDA's statement.

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A licensed clinician decides whether treatment is appropriate. A prescription is not guaranteed.

Related diagnostics and treatments

• Semaglutide for weight loss (overview) →
• Semaglutide side effects →
• Semaglutide products compared →
• Wegovy tablets (oral semaglutide) →
• Semaglutide for longevity: what the evidence shows →
• How FDA drug approval works →