Eli Lilly and Company — Zepbound FDA Review (NDA217806, ORIG 1, 2023)
Eli Lilly and Company · 2023 · FDA Review (openFDA) · company profile →
Report summary
The FDA recommends approval for Eli Lilly's Zepbound (tirzepatide), a dual GLP-1/GIP receptor agonist, for chronic weight management in adults with obesity or overweight and at least one weight-related comorbidity. Supported by Phase 3 trials SURMOUNT-1 and SURMOUNT-2, Zepbound demonstrated significant and durable weight loss and improved metabolic markers. Administered as a once-weekly subcutaneous injection (5, 10, or 15 mg maintenance doses after escalation), its efficacy and safety were robustly evaluated. Safety findings included balanced serious adverse events, but increased gastrointestinal issues, hypersensitivity, and injection site reactions. Labeling updates address risks like acute kidney injury, pancreatitis, hypoglycemia, and suicidal ideation, with postmarketing requirements including pediatric studies and long-term medullary thyroid carcinoma surveillance.
Key findings — cited to the page
| Irritability (Psychiatric TEAE) | 0.1 % | · p.198 |
| Irritability (Psychiatric TEAE) | 0.0 % | · p.198 |
| NDA number | 217806 | Zepbound (tirzepatide) · p.12 |
| Applicant | Eli Lilly and Company (Lilly) | · p.2 |
| Dosage Form | Injection 2.5 mg/0.5 mL in a single-dose pen | Zepbound (tirzepatide) · p.2 |
| Dosage Form | Injection 5 mg/0.5 mL in a single-dose pen | Zepbound (tirzepatide) · p.2 |
| Dosage Form | Injection 10 mg/0.5 mL in a single-dose pen | Zepbound (tirzepatide) · p.2 |
| Dosage Form | Injection 7.5 mg/0.5 mL in a single-dose pen | Zepbound (tirzepatide) · p.2 |
| Dosage Form | Injection 12.5 mg/0.5 mL in a single-dose pen | Zepbound (tirzepatide) · p.2 |
| Dosage Form | Injection 15 mg/0.5 mL in a single-dose pen | Zepbound (tirzepatide) · p.2 |
| Trial name | GPHK (SURMOUNT-1) | Zepbound (tirzepatide) · p.12 |
| Maximum dosage | 15 mg mg | Zepbound (tirzepatide) · p.2 |
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 →