GLP-1 receptor agonist

Semaglutide: approvals, trials, half-life and tools

Updated by the GLP Ladder Editorial Team. Editorial policy.

Status as of

FDA approved as Ozempic (type 2 diabetes) and Wegovy (weight management, cardiovascular risk reduction).

Source: Novo Nordisk, Jun 18, 2026. Also called: Wegovy, Ozempic, Rybelsus.

Short answer

Semaglutide is a GLP-1 receptor agonist sold as Ozempic (type 2 diabetes, approved December 5, 2017) and Wegovy (weight reduction, approved June 4, 2021). Wegovy added cardiovascular risk reduction in 2024, MASH in 2025, a daily pill on December 22, 2025 and 7.2 mg on March 19, 2026. Half-life is about 1 week. As of Oct 19, 2026.

Semaglutide tools

Status timeline

Semaglutide: approvals, trial readouts and regulatory notices (newest first, each with its source)

  1. Wegovy HD (7.2 mg) approved

    FDA approval. Source: FDA.

  2. Wegovy pill (oral semaglutide 25 mg) approved

    FDA approval. Source: Novo Nordisk.

  3. Wegovy approved for MASH (accelerated approval)

    FDA approval. Source: FDA.

  4. FDA declares the semaglutide shortage resolved

    Regulatory. Source: FDA.

  5. Wegovy approved to reduce cardiovascular risk

    FDA approval. Source: FDA.

  6. Wegovy approved for chronic weight management

    FDA approval. Source: FDA.

  7. Ozempic approved for type 2 diabetes

    FDA approval. Source: FDA.

Pharmacokinetic parameters

Semaglutide: published parameters and the values the plotter uses
ParameterPublishedModel value
Half-lifeFDA label: elimination half-life of about 1 week. source7 days
Time to peakFDA label: maximum concentration reached 1 to 3 days after a dose; the model uses 36 hours. source36 h
Bioavailability89% absolute (label)1 (relative)

Key trial results

Semaglutide: headline results by trial (different trials, populations and analyses; do not compare across rows)
TrialPopulationWeeksArmResultComparatorAnalysis
STEP 1Obesity or overweight without diabetes682.4 mg−14.9% body weightPlacebo −2.4%Treatment-policy estimand
SELECTCardiovascular disease and overweight, no diabetesevent-driven2.4 mgMACE 6.5% of participantsPlacebo 8.0% (HR 0.80)Primary cardiovascular endpoint
SURMOUNT-5Obesity without diabetes (open label)721.7 or 2.4 mg−13.7% body weightTirzepatide 10/15 mg −20.2%Least-squares mean; estimand not named in abstract

Published dose ladders

What semaglutide is

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, the drug class named in both the Ozempic and Wegovy labels. (Novo Nordisk, Jun 18, 2026) (Novo Nordisk, Jun 1, 2026)

As an injection it is given under the skin once weekly. Its elimination half-life is about 1 week, peak levels come 1 to 3 days after a dose, and absolute bioavailability is 89%. The Wegovy tablet is taken once daily, and only about 1% to 2% of each tablet dose is absorbed, which is why tablet doses run from 1.5 mg to 25 mg. (Novo Nordisk, Jun 18, 2026) See the semaglutide half-life guide for the full numbers.

Brands and approvals

Semaglutide FDA approvals by product and indication
DateProductApproval
December 5, 2017OzempicOriginal approval, type 2 diabetes
June 4, 2021Wegovy 2.4 mgChronic weight management
March 8, 2024WegovyReduce risk of cardiovascular death, heart attack and stroke
August 15, 2025WegovyNoncirrhotic MASH with F2–F3 fibrosis (accelerated approval)
December 22, 2025Wegovy tabletsOnce-daily oral semaglutide, 25 mg maintenance
March 19, 2026Wegovy HD7.2 mg weekly dose
(FDA, Oct 19, 2026) (FDA, Oct 19, 2026) (FDA, Mar 8, 2024) (FDA, Aug 15, 2025) (Novo Nordisk, Dec 22, 2025) (FDA, Mar 19, 2026)

Ozempic’s label now covers glycemic control in type 2 diabetes, cardiovascular risk reduction in adults with type 2 diabetes and established heart disease, and kidney outcomes in type 2 diabetes with chronic kidney disease. (Novo Nordisk, Jun 1, 2026)

The MASH approval came through the accelerated pathway, with breakthrough therapy designation. It rested on ESSENCE part 1, where 36.8% on Wegovy vs 22.4% on placebo had improved liver fibrosis without worsening steatohepatitis at 72 weeks. (FDA, Aug 15, 2025) (Novo Nordisk, Aug 15, 2025) Wegovy HD was approved 54 days after filing under the FDA’s National Priority Voucher pilot. (FDA, Mar 19, 2026)

The label dose ladders are 0.25 → 0.5 → 1 → 1.7 → 2.4 mg for Wegovy and 0.25 → 0.5 → 1 → 2 mg for Ozempic. Each step lasts at least 4 weeks. They are laid out in the semaglutide dosage chart and the titration calculator.

Key trials

Efficacy numbers depend on the analysis. The treatment-policy estimand counts everyone randomized, whether or not they stayed on the drug; trial-product or efficacy estimands assume everyone stayed on treatment and usually give larger numbers. Each figure below names its analysis.

Selected semaglutide trial results (published primary endpoints)
TrialPopulationDurationResult
STEP 11,961 adults with overweight or obesity, no diabetes68 weeksWeight −14.9% vs −2.4% placebo (treatment-policy)
SELECT17,604 adults aged 45+ with heart disease and BMI ≥27, no diabetesMean 39.8 monthsMajor cardiovascular events 6.5% vs 8.0%; HR 0.80
SURMOUNT-5751 adults with obesity, no type 2 diabetes72 weeksWeight −13.7% semaglutide vs −20.2% tirzepatide
Wegovy label Study 8Adults with obesity, no type 2 diabetes72 weeksWeight −18.8% (7.2 mg), −15.5% (2.4 mg), −3.9% placebo (ITT)
Wegovy label Study 7Adults, oral 25 mg tablet64 weeksWeight −13.6% vs −2.4% placebo (ITT)
(New England Journal of Medicine, Mar 18, 2021) (New England Journal of Medicine, Dec 14, 2023) (New England Journal of Medicine, Jul 3, 2025) (Novo Nordisk, Jun 18, 2026)

STEP 1 corresponds to Study 2 in the Wegovy label. The estimated treatment difference was −12.4 percentage points, and 50.5% on semaglutide lost at least 15% of body weight vs 4.9% on placebo. In absolute terms, mean change was −15.3 kg vs −2.6 kg. (New England Journal of Medicine, Mar 18, 2021)

SELECT tested heart outcomes rather than weight. The hazard ratio of 0.80 (95% CI 0.72 to 0.90) is often described as a 20% relative risk reduction; that figure is derived as 1 minus 0.80. Adverse events led to permanent discontinuation in 16.6% vs 8.2%. (New England Journal of Medicine, Dec 14, 2023)

SURMOUNT-5 compared semaglutide head-to-head with tirzepatide at the maximum tolerated dose of each (semaglutide 1.7 or 2.4 mg; tirzepatide 10 or 15 mg). It was open-label and funded by Lilly, which makes tirzepatide. Waist circumference fell 13.0 cm with semaglutide vs 18.4 cm with tirzepatide. (New England Journal of Medicine, Jul 3, 2025) Trials differ in population, duration and analysis, so results from different trials in the table should not be compared directly.

Side-effect rates from the labels are in the semaglutide side effects guide.

Compounding status

Semaglutide injections were on the FDA drug shortage list from March 2022 (Wegovy) and August 2022 (Ozempic). On February 21, 2025, the FDA declared the shortage resolved. Its enforcement discretion ended on April 22, 2025 for 503A pharmacies and on May 22, 2025 for 503B outsourcing facilities. (FDA, Feb 21, 2025)

The FDA’s compounding page, current as of April 1, 2026, states that “Compounded drugs are not approved by FDA.” It adds that a product combining semaglutide with another ingredient, such as vitamin B12, may still be “essentially a copy.” (FDA, Apr 1, 2026) On February 6, 2026, the FDA announced its intent to restrict GLP-1 active ingredients used in non-approved compounded drugs. (FDA, Feb 6, 2026)

Compounded and research-labeled semaglutide are not interchangeable with Wegovy or Ozempic. Branded semaglutide comes ready to use in pens, syringes or tablets and is never reconstituted. For the arithmetic only, see the reconstitution chart and the units calculator.

Tools for semaglutide

Every tool reproduces the label or plain arithmetic. None replaces a prescription; talk to your prescriber about your treatment.

Semaglutide guides

Frequently asked questions

What is semaglutide?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, the active ingredient in Ozempic and Wegovy. Ozempic is approved for adults with type 2 diabetes. Wegovy is approved for weight reduction, cardiovascular risk reduction and noncirrhotic MASH with moderate to advanced fibrosis. Both injections are given once weekly; Wegovy also comes as a once-daily tablet.

Is semaglutide FDA approved?

Yes, as branded products. Ozempic was approved on December 5, 2017 and Wegovy on June 4, 2021, with later approvals for cardiovascular risk reduction (March 8, 2024), MASH (August 15, 2025, accelerated approval), the Wegovy pill (December 22, 2025) and Wegovy HD 7.2 mg (March 19, 2026). Compounded semaglutide is not FDA approved.

What is the difference between Ozempic and Wegovy?

Both contain semaglutide. Ozempic is labeled for type 2 diabetes, with weekly doses of 0.5, 1 or 2 mg after a 0.25 mg start. Wegovy is labeled for weight reduction and cardiovascular risk reduction, among other uses, with a recommended 2.4 mg weekly maintenance dose and an optional 7.2 mg dose for adult weight reduction.

How much weight do people lose on semaglutide?

In the STEP 1 trial of adults without diabetes, mean body-weight change at 68 weeks was −14.9% with semaglutide 2.4 mg vs −2.4% with placebo, using the treatment-policy estimand (which counts everyone regardless of whether they stayed on treatment). Half of participants on semaglutide (50.5%) lost 15% or more. Individual results vary; talk to your prescriber.

Is compounded semaglutide still allowed?

The FDA declared the semaglutide injection shortage resolved on February 21, 2025. Its enforcement discretion for compounded copies ended April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities. FDA says compounded drugs are not FDA approved, and on February 6, 2026 it announced plans to restrict GLP-1 ingredients for non-approved compounded drugs.

Sources

  1. WEGOVY (semaglutide) injection, for subcutaneous use; WEGOVY (semaglutide) tablets, for oral use - Full Prescribing Information (SPL, Revised 6/2026). Novo Nordisk / National Library of Medicine DailyMed, Jun 18, 2026. Accessed Oct 19, 2026.
  2. OZEMPIC (semaglutide) injection, for subcutaneous use - Full Prescribing Information (SPL). Novo Nordisk / National Library of Medicine DailyMed, Jun 1, 2026. Accessed Oct 19, 2026.
  3. Drugs@FDA record NDA209637 (OZEMPIC semaglutide injection) - submissions history. U.S. Food and Drug Administration (openFDA Drugs@FDA API), Oct 19, 2026. Accessed Oct 19, 2026.
  4. Drugs@FDA record NDA215256 (WEGOVY semaglutide injection) - submissions history. U.S. Food and Drug Administration (openFDA Drugs@FDA API), Oct 19, 2026. Accessed Oct 19, 2026.
  5. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. U.S. Food and Drug Administration, Mar 8, 2024. Accessed Oct 19, 2026.
  6. FDA Approves Treatment for Serious Liver Disease Known as 'MASH'. U.S. Food and Drug Administration, Aug 15, 2025. Accessed Oct 19, 2026.
  7. Novo Nordisk A/S: Wegovy® approved in the US for the treatment of MASH. Novo Nordisk A/S, Aug 15, 2025. Accessed Oct 19, 2026.
  8. FDA Approves Oral Wegovy® Pill. Novo Nordisk Inc. (US), Dec 22, 2025. Accessed Oct 19, 2026.
  9. FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide. U.S. Food and Drug Administration, Mar 19, 2026. Accessed Oct 19, 2026.
  10. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine (Wilding JPH et al.; PMID 33567185), Mar 18, 2021. Accessed Oct 19, 2026.
  11. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. New England Journal of Medicine (Lincoff AM et al.; PMID 37952131), Dec 14, 2023. Accessed Oct 19, 2026.
  12. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. New England Journal of Medicine (Aronne LJ et al.; PMID 40353578), Jul 3, 2025. Accessed Oct 19, 2026.
  13. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy). U.S. Food and Drug Administration, Feb 21, 2025. Accessed Oct 19, 2026.
  14. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. U.S. Food and Drug Administration, Apr 1, 2026. Accessed Oct 19, 2026.
  15. FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs. U.S. Food and Drug Administration, Feb 6, 2026. Accessed Oct 19, 2026.