Tirzepatide
Also known as: LY3298176, Mounjaro, Zepbound
Tirzepatide is currently approved product — specific indication/route for fda-approved drug product.
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A dual GIP/GLP-1 receptor agonist peptide. FDA has approved it as the active ingredient in Mounjaro and Zepbound for specific indications, routes, strengths, and products.
Current status
FDA-approved drug product: Approved product — specific indication/route; National drug shortage: Shortage resolved; 503A compounding of copies: Copy restrictions apply after shortage resolution
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Approved product — specific indication/route | Nov 8, 2023 | United States federal | Mounjaro (tirzepatide) injection approved 2022-05-13 for T2D; Zepbound (tirzepatide) injection approved 2023-11-08 for chronic weight management. | |
| National drug shortage | Shortage resolved | Dec 19, 2024 | United States federal | FDA determined the tirzepatide injection shortage was resolved on 2024-12-19. Localized supply disruptions may still occur. | |
| 503A compounding of copies | Copy restrictions apply after shortage resolution | Dec 19, 2024 | United States federal | Compounded drugs that are essentially copies of Mounjaro/Zepbound are generally restricted under 503A now that the shortage is resolved. FDA's 60/90-day enforcement-discretion period has ended. |
What this means
- ✓ FDA-approved drug product: Approved product — specific indication/route. Mounjaro (tirzepatide) injection approved 2022-05-13 for T2D; Zepbound (tirzepatide) injection approved 2023-11-08 for chronic weight management.
- ✓ National drug shortage: Shortage resolved. FDA determined the tirzepatide injection shortage was resolved on 2024-12-19. Localized supply disruptions may still occur.
- ✓ 503A compounding of copies: Copy restrictions apply after shortage resolution. Compounded drugs that are essentially copies of Mounjaro/Zepbound are generally restricted under 503A now that the shortage is resolved. FDA's 60/90-day enforcement-discretion period has ended.
What this does not mean
- ✗ Status in one jurisdiction does not automatically apply elsewhere.
- ✗ An approved active ingredient is not the same as an approved finished product.
- ✗ “Research use” labeling does not make an unapproved drug lawful for human use.
Timeline
FDA resolves tirzepatide shortage
final/effectiveDeclaratory order ends shortage status and limits compounding-copy exceptions.
FDA approves Zepbound
finalApproved for chronic weight management.
FDA approves Mounjaro
finalApproved for glycemic control in adults with type 2 diabetes.
Controlling sources
- Mounjaro (tirzepatide) Approval Letter
U.S. Food and Drug Administration · Approval letter · NDA 215866
- Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products
U.S. Food and Drug Administration · Declaratory order · Drug Shortages