# Semaglutide: FDA Status, Research and Uses

> Semaglutide FDA status, Ozempic, Wegovy and Rybelsus labels, the 2025 end of the shortage, compounding rules, key trials and label safety.

- Canonical URL: https://livingpluspeptides.com/peptides/semaglutide/
- Last updated: October 25, 2026
- Publisher: Living+

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].

## Regulatory status

- FDA approved: Yes: [Ozempic injection (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79), [Wegovy injection and tablets (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b), [Rybelsus and Ozempic tablets (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98)
- 503A compounding: [Component of an FDA-approved drug](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize). Shortage 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).
- 503B bulks list: [FDA proposed not to include](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal). FDA 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 prohibited: [No](https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf) (Not prohibited; on the 2026 Monitoring Program (markers of semaglutide, in and out of competition))
- FDA drug shortage: [Shortage resolved](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize). FDA declared the semaglutide injection shortage resolved Feb 21, 2025. The shortage database now lists only Rybelsus tablets (3, 7 and 14 mg) as to be discontinued (posted June 4, 2026), to be replaced by Ozempic tablets.
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize), [FDA: FDA proposes to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list](https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list), [Federal Register: 503B bulks list notice (May 1, 2026)](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal), [FDA: Concerns with unapproved GLP-1 drugs used for weight loss](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss), [WADA: 2026 Monitoring Program](https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [Federal Register: 503B bulks list notice, extension of comment period (Jun 26, 2026)](https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal), [Drugs@FDA: NDA 209637 Ozempic](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637), [openFDA drug shortages query: semaglutide](https://api.fda.gov/drug/shortages.json?search=generic_name:%22semaglutide%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: GLP-1 receptor agonist (GLP-1 analog) [1]
- Amino-acid 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 used 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

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: ESSENCE (part 1) | 2025 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/40305708/) |
| Human trial: FLOW | 2024 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/38785209/) |
| Human trial: SELECT | 2023 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/37952131/) |
| Human trial: STEP 1 | 2021 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/33567185/) |
| Human trial: PIONEER 6 (oral) | 2019 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/31185157/) |
| Human trial: SUSTAIN-6 | 2016 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/27633186/) |

## 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].

- [FDA: Concerns with unapproved GLP-1 drugs used for weight loss (page current as of Oct 1, 2026)](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss) (2026-10-01)
- [FDA: FDA intends to take action against non-FDA-approved GLP-1 drugs](https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs) (2026-02-06)

## Legal and regulatory status

- 2026-05-01: FDA published a notice proposing not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list, so outsourcing facilities could not compound them from bulk powder. A June 26, 2026 notice extended the comment period to July 30, 2026. No final decision was found as of Oct 25, 2026 [15, 16, 22]. [Source](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
- 2026-03-19: FDA approved a higher 7.2 mg dose of Wegovy injection, called Wegovy HD, for weight loss and weight maintenance in certain adults [19]. [Source](https://www.fda.gov/news-events/press-announcements/fda-approves-fourth-product-under-national-priority-voucher-program-higher-dose-semaglutide)
- 2026-02-06: FDA said it intends to restrict GLP-1 active ingredients meant for non-approved compounded drugs and to act against misleading ads, including claims that compounded products are generics [14]. [Source](https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs)
- 2026-01-01: The WADA 2026 Monitoring Program tracks markers of semaglutide in and out of competition. Semaglutide is monitored, not prohibited [20, 21]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf)
- 2025-12-22: FDA approved Wegovy (semaglutide) tablets for weight reduction and heart risk reduction in adults [18]. [Source](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218316Orig1s000ltr.pdf)
- 2025-08-15: FDA granted accelerated approval of Wegovy injection for MASH with moderate to advanced liver fibrosis in adults [17]. [Source](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s024ltr.pdf)
- 2025-05-22: End of FDA's grace period for 503B outsourcing facilities compounding semaglutide under shortage rules [12]. [Source](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)
- 2025-04-24: A federal court denied a request to block FDA's decision. FDA said the 503A grace period for pharmacies had ended [12]. [Source](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)
- 2025-02-21: FDA declared the semaglutide injection shortage resolved [12]. [Source](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-semaglutide).

## Frequently asked 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](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79)
2. [DailyMed: Wegovy (semaglutide) injection and tablets label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b)
3. [DailyMed: Rybelsus and Ozempic (semaglutide) tablets label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98)
4. [Lau et al. 2015, J Med Chem: Discovery of semaglutide (PubMed)](https://pubmed.ncbi.nlm.nih.gov/26308095/)
5. [Al Musaimi et al. 2018, Pharmaceuticals: 2017 FDA peptide harvest (PMC)](https://pmc.ncbi.nlm.nih.gov/articles/PMC6027222/)
6. [Wilding et al. 2021, NEJM: STEP 1 (PubMed)](https://pubmed.ncbi.nlm.nih.gov/33567185/)
7. [Marso et al. 2016, NEJM: SUSTAIN-6 (PubMed)](https://pubmed.ncbi.nlm.nih.gov/27633186/)
8. [Lincoff et al. 2023, NEJM: SELECT (PubMed)](https://pubmed.ncbi.nlm.nih.gov/37952131/)
9. [Perkovic et al. 2024, NEJM: FLOW (PubMed)](https://pubmed.ncbi.nlm.nih.gov/38785209/)
10. [Sanyal et al. 2025, NEJM: ESSENCE (PubMed)](https://pubmed.ncbi.nlm.nih.gov/40305708/)
11. [Husain et al. 2019, NEJM: PIONEER 6 (PubMed)](https://pubmed.ncbi.nlm.nih.gov/31185157/)
12. [FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)
13. [FDA: Concerns with unapproved GLP-1 drugs used for weight loss](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
14. [FDA: FDA intends to take action against non-FDA-approved GLP-1 drugs (Feb 6, 2026)](https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs)
15. [FDA: FDA proposes to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list (Apr 30, 2026)](https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list)
16. [Federal Register: List of bulk drug substances for which there is a clinical need under section 503B (May 1, 2026)](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
17. [FDA: NDA 215256/S-024 accelerated approval letter, Wegovy for MASH (Aug 15, 2025)](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s024ltr.pdf)
18. [FDA: NDA 218316 approval letter, Wegovy (semaglutide) tablets](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218316Orig1s000ltr.pdf)
19. [FDA: FDA approves higher dose semaglutide (Wegovy HD) (Mar 19, 2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-fourth-product-under-national-priority-voucher-program-higher-dose-semaglutide)
20. [WADA: 2026 Monitoring Program](https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf)
21. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
22. [Federal Register: 503B bulks list notice, extension of comment period (Jun 26, 2026)](https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)

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