ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/BLA 217806, 2026)
Eli Lilly and Company · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
Eli Lilly's Zepbound (tirzepatide) received FDA approval on December 20, 2024, for treating moderate to severe obstructive sleep apnea (OSA) in obese adults. This sNDA approval, supported by two pivotal 52-week Phase 3 trials (GPI1 and GPI2), demonstrated significant reductions in the Apnea-Hypopnea Index (AHI) and improvements in sleep-related outcomes. Zepbound's efficacy stems from substantial weight loss, consistent with its established safety profile, which includes common gastrointestinal issues and a warning for thyroid C-cell tumors. The FDA waived pediatric studies for ages 0-5 and deferred for 6-17, requiring postmarketing studies. The approval includes updated labeling and dosage recommendations for the 10mg or 15mg once-weekly subcutaneous injection.
Key findings — cited to the page
| Hypotension (ZEPBOUND 15 mg) | 2 % | Study 1 and Study 2 · p.16 |
| pH of ZEPBOUND solution | 6.5 – 7.5 | · p.20 |
| Applicant Proposed Indication | treatment for moderate to severe obstructive sleep apnea (OSA) in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) | Zepbound (tirzepatide) injection · p.57 |
| Recommendation on Regulatory Action | Approval | Zepbound (tirzepatide) injection · p.57 |
| Recommended Indication | treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity | Zepbound (tirzepatide) injection · p.57 |
| Approval date for T2DM indication | May 13, 2022 | Zepbound (tirzepatide) · p.76 |
| Approval date for chronic weight management indication | November 8, 2023 | Zepbound (tirzepatide) · p.76 |
| Recommended regulatory action for OSA with obesity | Approval | Zepbound (tirzepatide) · p.76 |
| Approval date | May 13, 2022 | Mounjaro (tirzepatide) · United States · p.90 |
| Approval date | November 8, 2023 | Zepbound (tirzepatide) · United States · p.90 |
| Difference from Placebo in AHI (LS Mean) | -23.8 | GPI2 · p.140 |
| Nausea (ZEPBOUND 5 mg) | 25 % | Study 1 and Study 2 · p.16 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →