What is Semaglutide?

The short answer

Semaglutide is a lab-made peptide that copies a hormone the gut makes after you eat. In the US, you need a prescription to get Semaglutide.

What it is
Copies the gut hormone GLP-1 and binds its receptor.
What people look into
Weight

9 sources
Status as of October 4, 2026
How we source
Ellum doesn't sell peptides.

By Ellum EditorialPublished October 6, 2026Updated October 12, 2026AI use

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What it is

Type: GLP-1 receptor agonist (peptide)
Also known as: sema
How it works: Copies the gut hormone GLP-1 and binds its receptor.

Regulatory status

FDA-approved (Rx) How we label status

As of October 4, 2026, Semaglutide is an FDA-approved prescription drug for type 2 diabetes; chronic weight management; cardiovascular risk reduction; reducing the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, Ozempic injection only; noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in adults, Wegovy injection only, under accelerated approval.

See Semaglutide in the Index →

Federal (FDA): Approved Rx (Ozempic NDA209637 2017; Wegovy NDA215256 2021; Rybelsus NDA213051 2019; Ozempic tablets NDA213051 2026; Wegovy tablet NDA218316 2025)
503A compounding: Approved-drug component; shortage resolved 2025-02-21 (503A window ended, PI denied 2025-04-24; 503B ended 2025-05-22); 'essentially a copy' limits apply (as of April 1, 2026)
WADA 2026: Not prohibited (monitoring)

Timeline

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Date	What happened	Source
May 1, 2026	FDA Federal Register notice proposes not to include semaglutide on the 503B bulks list for outsourcing facility compounding.	Federal Register, event of May 1, 2026, on federalregister.gov

US enforcement actions

78 US enforcement actions since 2023.

Actions by US federal and state agencies whose documents name Semaglutide. Each row links to the government's own document.

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Date	Agency	Action	Document
September 18, 2026	FDA	Warning letter	FDA document, warning letter, September 18, 2026, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 1 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 2 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 3 of 5 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 4 of 5 that day, on fda.gov

Show all 78 enforcement actions

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Date	Agency	Action	Document
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 5 of 5 that day, on fda.gov
July 23, 2026	US Justice Department	Other action	US Department of Justice action, July 23, 2026
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 1 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 2 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 3 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 4 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 5 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 6 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 7 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 8 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 9 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 10 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 11 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 12 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 13 of 14 that day, on fda.gov
June 8, 2026	FDA	Warning letter	FDA document, warning letter, June 8, 2026, 14 of 14 that day, on fda.gov
May 6, 2026	Connecticut Attorney General	Settlement	Connecticut document, settlement, May 6, 2026, 1 of 2 that day, on portal.ct.gov
May 6, 2026	Connecticut Attorney General	Settlement	Connecticut document, settlement, May 6, 2026, 2 of 2 that day, on portal.ct.gov
May 1, 2026	FDA	Warning letter	FDA document, warning letter, May 1, 2026, on fda.gov
April 14, 2026	FDA	Warning letter	FDA document, warning letter, April 14, 2026, on fda.gov
April 7, 2026	FDA	Warning letter	FDA document, warning letter, April 7, 2026, on fda.gov
April 1, 2026	US Justice Department	Indictment	Justice Department document, indictment, April 1, 2026, on justice.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 1 of 3 that day, on fda.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 2 of 3 that day, on fda.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 3 of 3 that day, on fda.gov
February 20, 2026	FDA	Warning letter	FDA document, warning letter, February 20, 2026, 1 of 4 that day, on fda.gov
February 20, 2026	FDA	Warning letter	FDA document, warning letter, February 20, 2026, 2 of 4 that day, on fda.gov
February 20, 2026	FDA	Warning letter	FDA document, warning letter, February 20, 2026, 3 of 4 that day, on fda.gov
February 20, 2026	FDA	Warning letter	FDA document, warning letter, February 20, 2026, 4 of 4 that day, on fda.gov
January 20, 2026	FDA	Warning letter	FDA document, warning letter, January 20, 2026, on fda.gov
January 16, 2026	FDA	Warning letter	FDA document, warning letter, January 16, 2026, on fda.gov
January 12, 2026	Alabama Attorney General	Settlement	Alabama document, settlement, January 12, 2026, on alabamaag.gov
December 3, 2025	Connecticut Attorney General	Other action	Connecticut document, other action, December 3, 2025, 1 of 3 that day, on portal.ct.gov
December 3, 2025	Connecticut Attorney General	Other action	Connecticut document, other action, December 3, 2025, 2 of 3 that day, on portal.ct.gov
December 3, 2025	Connecticut Attorney General	Other action	Connecticut document, other action, December 3, 2025, 3 of 3 that day, on portal.ct.gov
November 10, 2025	Alabama Attorney General	Other action	Alabama document, other action, November 10, 2025, on alabamaag.gov
September 11, 2025	FDA	Warning letter	FDA document, warning letter, September 11, 2025, on fda.gov
September 10, 2025	FDA	Warning letter	FDA document, warning letter, September 10, 2025, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 1 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 2 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 3 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 4 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 5 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 6 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 7 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 8 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 9 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 10 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 11 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 12 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 13 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 14 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 15 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 16 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 17 of 18 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 18 of 18 that day, on fda.gov
July 29, 2025	FDA	Warning letter	FDA document, warning letter, July 29, 2025, on fda.gov
July 9, 2025	FDA	Import alert	FDA document, import alert, July 9, 2025, on fda.gov
June 12, 2025	FDA	Warning letter	FDA document, warning letter, June 12, 2025, on fda.gov
May 21, 2025	Connecticut Attorney General	Other action	Connecticut document, other action, May 21, 2025, 1 of 2 that day, on portal.ct.gov
May 21, 2025	Connecticut Attorney General	Other action	Connecticut document, other action, May 21, 2025, 2 of 2 that day, on portal.ct.gov
May 5, 2025	FDA	Warning letter	FDA document, warning letter, May 5, 2025, on fda.gov
April 23, 2025	FDA	Warning letter	FDA document, warning letter, April 23, 2025, on fda.gov
April 14, 2025	US Justice Department	Plea	Justice Department document, plea, April 14, 2025, on justice.gov
February 26, 2025	FDA	Warning letter	FDA document, warning letter, February 26, 2025, on fda.gov
December 10, 2024	FDA	Warning letter	FDA document, warning letter, December 10, 2024, 1 of 4 that day, on fda.gov
December 10, 2024	FDA	Warning letter	FDA document, warning letter, December 10, 2024, 2 of 4 that day, on fda.gov
December 10, 2024	FDA	Warning letter	FDA document, warning letter, December 10, 2024, 3 of 4 that day, on fda.gov
December 10, 2024	FDA	Warning letter	FDA document, warning letter, December 10, 2024, 4 of 4 that day, on fda.gov
February 7, 2024	FDA	Warning letter	FDA document, warning letter, February 7, 2024, 1 of 2 that day, on fda.gov
February 7, 2024	FDA	Warning letter	FDA document, warning letter, February 7, 2024, 2 of 2 that day, on fda.gov
October 2, 2023	FDA	Warning letter	FDA document, warning letter, October 2, 2023, 1 of 2 that day, on fda.gov
October 2, 2023	FDA	Warning letter	FDA document, warning letter, October 2, 2023, 2 of 2 that day, on fda.gov

Forms and brands

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Name	Kind	Status	FDA status	As of
Compounded semaglutide	Compounded form	Not FDA-approved	Not FDA-approved (compounded drugs are not FDA-approved)	October 4, 2026
Ozempic	Brand	FDA-approved (Rx)	Approved Rx (NDA209637, 2017; tablets NDA213051, 2026; type 2 diabetes; cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease, injection; cardiovascular risk reduction in adults with type 2 diabetes at high risk for major adverse cardiovascular events, tablets; reducing the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, injection only)	October 4, 2026
Rybelsus	Brand	FDA-approved (Rx)	Approved Rx (NDA213051, 2019; type 2 diabetes; cardiovascular risk reduction in adults with type 2 diabetes at high risk for major adverse cardiovascular events)	October 4, 2026
Semaglutide sodium / acetate (salt forms)	Salt	Not FDA-approved	Not FDA-approved	October 4, 2026
Wegovy	Brand	FDA-approved (Rx)	Approved Rx (NDA215256, 2021; tablet NDA218316, 2025; chronic weight management; cardiovascular risk reduction; noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in adults, injection only, under accelerated approval)	October 4, 2026

References

Sources as of October 4, 2026