What is Tirzepatide?

The short answer

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

What it is
Copies two gut hormones, GIP and GLP-1, and binds both of their receptors.
What people look into
Weight

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

By Ellum EditorialPublished October 6, 2026Updated October 11, 2026AI use

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What it is

Type: GIP/GLP-1 dual receptor agonist (peptide)
Also known as: tirz
How it works: Copies two gut hormones, GIP and GLP-1, and binds both of their receptors.

Regulatory status

FDA-approved (Rx) How we label status

As of October 4, 2026, Tirzepatide is an FDA-approved prescription drug for type 2 diabetes; cardiovascular risk reduction in adults with type 2 diabetes at high risk for major adverse cardiovascular events, Mounjaro only; chronic weight management; obstructive sleep apnea with obesity.

See Tirzepatide in the Index →

Federal (FDA): Approved Rx (Mounjaro NDA215866 2022; Zepbound NDA217806 2023)
503A compounding: Approved-drug component; shortage resolved 2024-12-19 (503A window ended, PI denied 2025-03-05; 503B ended 2025-03-19); '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 tirzepatide on the 503B bulks list for outsourcing facility compounding.	Federal Register, event of May 1, 2026, on federalregister.gov

US enforcement actions

61 US enforcement actions since 2023.

Actions by US federal and state agencies whose documents name Tirzepatide. 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 4 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 2 of 4 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 3 of 4 that day, on fda.gov
August 24, 2026	FDA	Warning letter	FDA document, warning letter, August 24, 2026, 4 of 4 that day, on fda.gov

Show all 61 enforcement actions

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Date	Agency	Action	Document
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 5 that day, on fda.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 2 of 5 that day, on fda.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 3 of 5 that day, on fda.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 4 of 5 that day, on fda.gov
March 31, 2026	FDA	Warning letter	FDA document, warning letter, March 31, 2026, 5 of 5 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 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 1 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 2 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 3 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 4 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 5 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 6 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 7 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 8 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 9 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 10 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 11 of 12 that day, on fda.gov
September 9, 2025	FDA	Warning letter	FDA document, warning letter, September 9, 2025, 12 of 12 that day, 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
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, 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, on fda.gov

Forms and brands

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Name	Kind	Status	FDA status	As of
Compounded tirzepatide	Compounded form	Not FDA-approved	Not FDA-approved (compounded drugs are not FDA-approved)	October 4, 2026
Mounjaro	Brand	FDA-approved (Rx)	Approved Rx (NDA215866, 2022; type 2 diabetes; cardiovascular risk reduction in adults with type 2 diabetes at high risk for major adverse cardiovascular events)	October 4, 2026
Zepbound	Brand	FDA-approved (Rx)	Approved Rx (NDA217806, 2023; weight management; OSA with obesity)	October 4, 2026

References

Sources as of October 4, 2026