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What Is Semaglutide? Ozempic, Wegovy, Rybelsus, Trials and FDA Status (2026)

Semaglutide is Novo Nordisk's GLP-1 receptor agonist, approved as Ozempic, Wegovy and Rybelsus. A sourced overview of its approvals, the STEP and SELECT trials, the end of the shortage and FDA's position on research-labeled semaglutide.

Semaglutide is a GLP-1 receptor agonist from Novo Nordisk, FDA-approved as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for weight management, cardiovascular risk reduction and a form of fatty liver disease. Vials sold online as "research" semaglutide are not those drugs. They have no approval behind them, and FDA has warned the companies that sell them.

Notice: Research peptides are sold for in-vitro laboratory research only. Research-labeled vials are not the approved drug, not for human or animal consumption, and this page is not medical advice. It contains no dosing or use guidance.

How semaglutide works

Semaglutide "mimics a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake," according to FDA's Wegovy announcement. It's a modified peptide with a fatty side chain that lets it bind to albumin in the blood, which is why the injection is given once a week.

It acts on one receptor. Tirzepatide adds a second (GIP), and the investigational retatrutide a third (glucagon). The head-to-head data is in semaglutide vs tirzepatide.

Approvals

DateProductWhat FDA approvedSource
December 5, 2017OzempicType 2 diabetes in adultsDrugs.com history
September 20, 2019RybelsusFirst oral GLP-1 for type 2 diabetesFDA
January 16, 2020OzempicCardiovascular risk reduction in type 2 diabetes with heart diseaseDrugs.com
June 4, 2021WegovyChronic weight management in adultsFDA
December 23, 2022WegovyObesity in teens 12 and olderDrugs.com
March 8, 2024WegovyCardiovascular risk reduction in overweight or obesity with heart diseaseDrugs.com
January 28, 2025OzempicKidney disease worsening and cardiovascular death in type 2 diabetes with chronic kidney diseaseDrugs.com
August 15, 2025WegovyMASH (accelerated approval)Drugs.com
December 22, 2025Wegovy pillFirst oral GLP-1 for weight lossDrugs.com
March 19, 2026Wegovy HDHigher-strength weekly injection (accelerated approval)Novo Nordisk

What the trials found

Novo Nordisk's main weight-management program is called STEP. Its cardiovascular outcomes trial in people without diabetes is SELECT. The figures below describe the approved drug in controlled trials, not any individual result.

STEP 1 (obesity, no diabetes)

1,961 adults, 68 weeks. Mean weight change was -14.9% on semaglutide versus -2.4% on placebo. 4.5% on semaglutide stopped because of gastrointestinal events, versus 0.8% on placebo (ACC summary; NEJM).

SELECT (cardiovascular outcomes)

17,604 adults with overweight or obesity and established cardiovascular disease, none with diabetes, followed for a mean of 40 months. Results, per the American College of Cardiology summary:

OutcomeSemaglutidePlacebo
Cardiovascular death, heart attack or stroke6.5%8.0%
Hazard ratio0.80 (95% CI 0.72-0.90)
Weight change at 104 weeks-9.4%-0.9%
Stopped due to adverse events16.6%8.2%

This trial was the basis for Wegovy's March 2024 cardiovascular indication.

STEP UP (Wegovy HD)

A 72-week phase 3 program. Novo Nordisk reported 20.7% mean weight loss on the efficacy estimand and 18.7% on the treatment-regimen estimand, which counts everyone regardless of adherence (Novo Nordisk, March 19, 2026).

Side effects

FDA lists nausea, diarrhea, vomiting, constipation and abdominal pain among Wegovy's most common side effects. Semaglutide products carry a boxed warning about thyroid C-cell tumors seen in rodents (FDA). The prescribing information is the authoritative source.

Shortage, compounding and research labels (October 2026)

  • Shortage over. FDA said on February 21, 2025 that the semaglutide injection shortage was resolved. Enforcement discretion for 503B outsourcing facilities ended May 22, 2025, and FDA says the period for state-licensed pharmacies "has ended" (FDA, content current as of April 1, 2026).
  • February 2026 crackdown. On February 6, 2026, FDA said it would restrict GLP-1 ingredients used in mass-marketed non-approved compounded drugs and act against misleading marketing of them (FDA).
  • 503B proposal. On April 30, 2026, FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list (Federal Register). We found no final decision as of October 21, 2026.
  • Salt forms. FDA says semaglutide sodium and semaglutide acetate "are different active ingredients than are used in the approved drugs" (FDA, current as of October 1, 2026).
  • Adverse events. As of May 31, 2026, FDA had received 990 adverse event reports for compounded semaglutide, which it says are likely underreported (same page).
  • "Research" labels. FDA says it has warned companies selling semaglutide "falsely labeled 'for research purposes' or 'not for human consumption.'" Its August 24, 2026 letter to Peptide Partners named a product sold as "GLP-1 S (Semaglutide)."

More: FDA peptide regulation in 2026 and our regulatory news log.

Research-grade vials: what the market looks like

On October 21, 2026, 37 vendors in our price index had semaglutide in stock, at a median of $8.25 per mg. Code names are common. The cheapest per mg were:

VendorListingPrice$/mg
True Research LabsSemaglutide (listed as GLP-1-SM) 30mg$84.00$2.80
Elite Research USAGLP(1)Sg Research Peptide 20mg$59.99$3.00
Maximum PeptidesSemaglutide 20mg$79.00$3.95

Prices are as listed on vendors' sites on October 21, 2026, and they change often. See the semaglutide price page for every listing and best semaglutide vendors for our certificate comparison.

None of the STEP or SELECT data applies to these vials. They aren't Novo Nordisk's product, and nobody outside the seller and its lab checks what's in them.

How to check a semaglutide COA

  1. The certificate names semaglutide, not just "GLP-1" or a code.
  2. Identity by mass spectrometry. Semaglutide's molecular weight is about 4,114 g/mol.
  3. The salt form is stated. FDA treats sodium and acetate salts as different active ingredients, and the salt changes how much peptide a labeled milligram contains (TFA vs acetate salts).
  4. Measured content against the label (purity vs net content).
  5. A lot number matching your vial, a recent date and a named lab you can verify.

Our COA guide and COA checklist explain each check.

Bottom line

Semaglutide is one of the most studied drugs in its class, approved in injectable and oral forms with diabetes, weight, cardiovascular, kidney and liver indications. The shortage that allowed widespread compounding ended in February 2025, and FDA tightened rules further in 2026. Research-labeled semaglutide isn't any of the approved products, and FDA has named it in warning letters.

Sources are linked inline and were checked October 21, 2026. We'll update this page when FDA finalizes its 503B decision or approves new semaglutide products.

FAQ

Frequently asked questions

What is semaglutide?

Semaglutide is a GLP-1 receptor agonist developed by Novo Nordisk. It mimics a gut hormone that acts on brain areas regulating appetite, and it's sold as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for weight management and other uses.

When was semaglutide approved?

FDA approved Ozempic on December 5, 2017, Rybelsus tablets on September 20, 2019, and Wegovy injection on June 4, 2021. A Wegovy pill followed on December 22, 2025, and a higher-strength Wegovy HD injection on March 19, 2026.

What did the SELECT trial show?

SELECT enrolled 17,604 adults with overweight or obesity and heart disease but no diabetes. Major cardiovascular events occurred in 6.5% on semaglutide versus 8.0% on placebo over a mean 40 months, a 20% relative reduction (hazard ratio 0.80).

Is the semaglutide shortage over?

Yes. FDA said on February 21, 2025 that the semaglutide injection shortage was resolved. Enforcement discretion for outsourcing facilities ended May 22, 2025, and FDA says the period for state-licensed pharmacies has also ended.

Is research semaglutide the same as Ozempic or Wegovy?

No. Research-labeled vials aren't made under Novo Nordisk's approval or checked by FDA. FDA says it has warned sellers of semaglutide 'falsely labeled for research purposes,' and that semaglutide sodium and acetate salts are different active ingredients from the approved drugs.

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