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Zepbound
Zepbound is a brand of tirzepatide from Eli Lilly, first approved by the FDA on 2023-11-08 under application NDA217806, not separately authorised in the European Union under this name, with no open FDA supply records.
Zepbound is Eli Lilly's brand of tirzepatide, approved under NDA217806. The same molecule is also sold as Mounjaro — a separate application with its own approved uses and its own supply record, which is why the two are tracked apart here rather than merged. Its current FDA label, effective 2026-08-28, covers obesity, sleep apnea. Nothing under this name is currently on the FDA shortage list.
Zepbound and Mounjaro are the same molecule. They are marketed under separate FDA applications with different approved indications, so they are distinct products on the regulatory record even though the active ingredient is identical. Compare the applications below. Side by side: Zepbound vs Mounjaro.
- Active ingredient
- tirzepatide
- Sponsor
- Eli Lilly
- FDA applications
- NDA217806
- First FDA action
- 2023-11-08
- Most recent FDA action
- 2026-08-26
- FDA actions on file
- 45
- EU authorisation
- Not under this name
- Active trials of tirzepatide
- 99
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
FDA record
Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.
| Date | Action | Application |
|---|---|---|
| 2026-08-26 | Efficacy | NDA217806 · label |
| 2026-08-26 | Efficacy | NDA217806 · label |
| 2026-08-26 | Efficacy | NDA217806 · label |
| 2026-02-25 | Labeling | NDA217806 · label |
| 2026-02-25 | Labeling | NDA217806 · label |
| 2026-02-25 | Labeling | NDA217806 · label |
| 2026-01-20 | Labeling | NDA217806 · label |
| 2026-01-20 | Labeling | NDA217806 · label |
| 2026-01-20 | Labeling | NDA217806 · label |
| 2026-01-07 | Manufacturing (CMC) | NDA217806 · label |
| 2026-01-07 | Manufacturing (CMC) | NDA217806 · label |
| 2026-01-07 | Manufacturing (CMC) | NDA217806 · label |
| 2025-09-25 | Labeling | NDA217806 · label |
| 2025-09-25 | Labeling | NDA217806 · label |
| 2025-09-25 | Labeling | NDA217806 · label |
| 2025-02-07 | Labeling | NDA217806 · label |
| 2025-02-07 | Labeling | NDA217806 · label |
| 2025-02-07 | Labeling | NDA217806 · label |
| 2024-12-20 | Efficacy | NDA217806 · label |
| 2024-12-20 | Efficacy | NDA217806 · label |
| 2024-12-20 | Efficacy | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Efficacy | NDA217806 · label |
| 2024-10-18 | Efficacy | NDA217806 · label |
| 2024-10-18 | Efficacy | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-10-18 | Labeling | NDA217806 · label |
| 2024-03-28 | Labeling | NDA217806 · label |
| 2024-03-28 | Labeling | NDA217806 · label |
| 2024-03-28 | Labeling | NDA217806 · label |
| 2023-11-08 | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated original | NDA217806 · label |
| 2023-11-08 | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated original | NDA217806 · label |
| 2023-11-08 | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated original | NDA217806 · label |
| Labeling | NDA217806 · label | |
| Labeling | NDA217806 · label | |
| Labeling | NDA217806 · label |
For the molecule behind this brand — every trial, every indication under study and the full research record — see tirzepatide.