What is tirzepatide, and what is it approved for?

Dual GIP and GLP-1 receptor agonist

FDA approved

Tirzepatide (Mounjaro and Zepbound)

Tirzepatide is a licensed dual GIP and GLP-1 receptor agonist. It is sold as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management and obstructive sleep apnea in adults with obesity. The two are the same molecule with different labels, and insurers treat them differently as a result.

By John Weeks Updated September 7, 2026

Approved for

Type 2 diabetes (Mounjaro)
Chronic weight management in adults with obesity or overweight with a weight-related condition (Zepbound)
Moderate to severe obstructive sleep apnea in adults with obesity (Zepbound)

Compounding status

Large-scale compounding of tirzepatide has closed, and the rules that closed it differ by country. See the note for this market below.

In United States. The tirzepatide shortage was declared resolved in October 2024, and enforcement discretion for 503B outsourcing facilities ended on 19 March 2025. On 30 April 2026 the FDA proposed removing tirzepatide from the 503B bulks list. A 503A pharmacy may still compound it for an individual patient where a prescriber documents a clinical need an approved product cannot meet. The FDA has explicitly rejected affordability and access as constituting clinical need.

Key facts

Approval status: Approved
Brand names: Mounjaro (diabetes), Zepbound (weight, sleep apnea)
Large-scale compounding: Closing. Proposed off the 503B bulks list, April 30, 2026

Sources

Every claim above is checked against the primary text, and the date is the day we last opened it.

2 cited records

1
Zepbound savings and self-pay pricing
Eli Lilly and Company Primary text read and checked Checked August 25, 2026
2
FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
U.S. Food and Drug Administration Primary text read and checked Checked August 25, 2026