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Semaglutide: FDA Status, Research and Uses

By Living+. Updated October 25, 2026.

Key takeaway

Semaglutide is a GLP-1 receptor agonist. The FDA first approved it in 2017. It is sold as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for weight, heart risk and MASH. FDA ended its shortage in February 2025, which closed the main path for mass compounding [1, 2, 12].

At a glance

Where it stands

Checked

  • FDA approvedYesAs Ozempic injection, Wegovy injection and tablets, Rybelsus and Ozempic tablets
  • Pharmacy compounding (503A)AllowedShortage resolved Feb 21, 2025; 503A grace period ended after the Apr 24, 2025 court ruling. FDA does not intend to act on four or fewer essentially-copy prescriptions per month (page current Apr 1, 2026).
  • Outsourcing facilities (503B)Proposed noFDA proposed not to include semaglutide on the 503B bulks list (Federal Register May 1, 2026; comment period extended to July 30, 2026 by a Jun 26, 2026 notice). No final decision found as of Oct 25, 2026. Not on the drug shortage list.
  • WADA (sport)Not listedNot prohibited; on the 2026 Monitoring Program (markers of semaglutide, in and out of competition)
Same data as the Status Tracker. Checked against 10 sources

Key facts

Class
GLP-1 receptor agonist (GLP-1 analog) [1]
Length
31 amino acids, with a fatty side chain (94% sequence match to human GLP-1) [5, 1]
Half-life
About 1 week (label) [1]
Route in studies
Under the skin once weekly (Ozempic, Wegovy) or by mouth once daily (Rybelsus, Ozempic and Wegovy tablets) [1, 2, 3]
First studied
2015 (discovery paper); first U.S. approval 2017 [4, 1]

How it works

Semaglutide is a man-made copy of GLP-1, a gut hormone the body releases after eating. The label says it shares 94% of its sequence with human GLP-1. It binds to and activates the GLP-1 receptor [1]. It is a chain of 31 amino acids with a fatty side chain attached [5].

The fatty side chain is why it lasts so long. It lets semaglutide stick to albumin, a protein in the blood. This slows how fast the kidneys clear it and protects it from breakdown. A change at position 8 shields it from the enzyme DPP-4 [1, 4]. The label gives a half-life of about one week, so the shot is given once a week [1].

When blood sugar is high, semaglutide raises insulin release and lowers glucagon release. These effects depend on glucose levels [1]. It also slows stomach emptying. GLP-1 receptors sit in brain areas that control appetite, and the Wegovy label says semaglutide lowers calorie intake, likely by acting on appetite [2].

The tablet forms contain salcaprozate sodium (SNAC), which the label calls an absorption enhancer [3]. The Wegovy label notes that blood levels after tablets vary more from person to person than after the shot [2].

What the research shows

6 human trials

  1. 2025Human trial

    ESSENCE (part 1)

    800 adults with MASH and liver fibrosis stage 2 or 3 (interim analysis) Phase 3, randomized, double-blind, placebo-controlled, 2.4 mg weekly, results at week 72

    Steatohepatitis resolved without worse fibrosis in 62.9% vs 34.3% with placebo [10]

    Read the study
  2. 2024Human trial

    FLOW

    3,533 adults with type 2 diabetes and chronic kidney disease Randomized, placebo-controlled, 1.0 mg weekly, median follow-up 3.4 years

    Risk of major kidney disease events was 24% lower than placebo (hazard ratio 0.76) [9]

    Read the study
  3. 2023Human trial

    SELECT

    17,604 adults with heart disease and overweight or obesity, without diabetes Randomized, double-blind, placebo-controlled, event-driven, mean follow-up 39.8 months

    Heart attack, stroke or heart death: 6.5% with semaglutide vs 8.0% with placebo (hazard ratio 0.80) [8]

    Read the study
  4. 2021Human trial

    STEP 1

    1,961 adults with obesity or overweight, without diabetes Randomized, double-blind, placebo-controlled, 68 weeks, 2.4 mg weekly plus lifestyle advice

    Body weight fell 14.9% with semaglutide vs 2.4% with placebo [6]

    Read the study
  5. 2019Human trial

    PIONEER 6 (oral)

    3,183 adults with type 2 diabetes at high heart risk Randomized, double-blind, placebo-controlled, event-driven, median 15.9 months

    Oral semaglutide did not raise heart risk: major heart events 3.8% vs 4.8% [11]

    Read the study
  6. 2016Human trial

    SUSTAIN-6

    3,297 adults with type 2 diabetes at high heart risk Randomized, placebo-controlled, 104 weeks, 0.5 or 1.0 mg weekly

    Major heart events: 6.6% vs 8.9% (hazard ratio 0.74). Eye (retinopathy) complications were higher with semaglutide [7]

    Read the study

Doses used in studies

Label dosing for Ozempic shots starts at 0.25 mg once weekly for 4 weeks, then 0.5 mg. The dose can step up to 1 mg and then 2 mg once weekly. The maximum is 2 mg once weekly [1]. Wegovy shots start at 0.25 mg once weekly and rise every 4 weeks. The usual maintenance dose is 2.4 mg once weekly, and the label also lists a 7.2 mg weekly dose for weight [2].

Tablets are taken once daily. Rybelsus starts at 3 mg and may rise to 7 mg and then 14 mg. Wegovy tablets start at 1.5 mg and rise to a 25 mg daily maintenance dose [3, 2]. In published trials, STEP 1, SELECT and ESSENCE used 2.4 mg weekly, SUSTAIN-6 used 0.5 or 1.0 mg weekly, and FLOW used 1.0 mg weekly [6, 8, 10, 7, 9].

Dosing is set by a licensed provider.

Side effects and safety

All semaglutide labels carry a boxed warning for thyroid C-cell tumors. Semaglutide caused these tumors in rodents, and it is not known if it causes them in humans. It must not be used by people with a personal or family history of medullary thyroid cancer or MEN 2 [1, 2].

The most common side effects on the Ozempic label are nausea, vomiting, diarrhea, stomach pain and constipation [1]. Label warnings include pancreatitis, gallbladder disease, low blood sugar when used with insulin or sulfonylureas, kidney injury from dehydration, severe stomach side effects, allergic reactions, diabetic eye (retinopathy) problems, faster heart rate, and a risk of breathing in stomach contents during anesthesia [2]. In SELECT, 16.6% stopped the drug for side effects vs 8.2% on placebo [8].

FDA warns that compounded and other unapproved versions are not reviewed for safety or quality. As of May 31, 2026, FDA had 990 adverse event reports tied to compounded semaglutide, including dosing errors. FDA also says salt forms such as semaglutide sodium and semaglutide acetate are different active ingredients from the approved drugs [13].

Common questions

Is semaglutide FDA approved?

Yes. Semaglutide was first approved in 2017. It is the active ingredient in Ozempic, Rybelsus and Wegovy [1, 2, 3].

What is the difference between Ozempic and Wegovy?

Both contain semaglutide. Ozempic is labeled for type 2 diabetes and related heart and kidney risk. Wegovy is labeled for weight reduction, heart risk in people with obesity or overweight, and MASH, and uses higher doses [1, 2].

Is there a semaglutide pill?

Yes. Rybelsus and Ozempic tablets are labeled for type 2 diabetes. Wegovy tablets were approved on Dec 22, 2025 for weight and heart risk reduction [3, 18].

Is compounded semaglutide still legal?

FDA ended the shortage on Feb 21, 2025, and its grace periods ended in spring 2025. Pharmacies may not regularly make copies of an approved drug. FDA does not plan to act on a pharmacy that fills four or fewer such prescriptions in a month [12].

Is semaglutide still in shortage?

No. FDA says semaglutide is not on its drug shortage list or on the 503B bulks list [12].

Are semaglutide sodium or acetate the same as the approved drug?

No. FDA says these salt forms are different active ingredients from those in approved semaglutide drugs [13].

Is semaglutide banned in sports?

No. It is not on the WADA 2026 Prohibited List. WADA does monitor markers of semaglutide in its 2026 Monitoring Program [20, 21].

What are the most common side effects of semaglutide?

Nausea, vomiting, diarrhea, stomach pain and constipation are the most common on the Ozempic label [1].

How long does semaglutide stay in the body?

The half-life is about one week. The label says it stays in the blood for about 5 weeks after the last dose [1].

Sources

  1. DailyMed: Ozempic (semaglutide) injection label
  2. DailyMed: Wegovy (semaglutide) injection and tablets label
  3. DailyMed: Rybelsus and Ozempic (semaglutide) tablets label
  4. Lau et al. 2015, J Med Chem: Discovery of semaglutide (PubMed)
  5. Al Musaimi et al. 2018, Pharmaceuticals: 2017 FDA peptide harvest (PMC)
  6. Wilding et al. 2021, NEJM: STEP 1 (PubMed)
  7. Marso et al. 2016, NEJM: SUSTAIN-6 (PubMed)
  8. Lincoff et al. 2023, NEJM: SELECT (PubMed)
  9. Perkovic et al. 2024, NEJM: FLOW (PubMed)
  10. Sanyal et al. 2025, NEJM: ESSENCE (PubMed)
  11. Husain et al. 2019, NEJM: PIONEER 6 (PubMed)
  12. FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
  13. FDA: Concerns with unapproved GLP-1 drugs used for weight loss
  14. FDA: FDA intends to take action against non-FDA-approved GLP-1 drugs (Feb 6, 2026)
  15. FDA: FDA proposes to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list (Apr 30, 2026)
  16. Federal Register: List of bulk drug substances for which there is a clinical need under section 503B (May 1, 2026)
  17. FDA: NDA 215256/S-024 accelerated approval letter, Wegovy for MASH (Aug 15, 2025)
  18. FDA: NDA 218316 approval letter, Wegovy (semaglutide) tablets
  19. FDA: FDA approves higher dose semaglutide (Wegovy HD) (Mar 19, 2026)
  20. WADA: 2026 Monitoring Program
  21. WADA: 2026 Prohibited List
  22. Federal Register: 503B bulks list notice, extension of comment period (Jun 26, 2026)

Updated October 25, 2026. Educational information, not medical advice.