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The first approval came in **May 2022**, when the FDA cleared tirzepatide as **Mounjaro** (NDA 215866) for the treatment of type 2 diabetes in adults, to be used alongside diet and exercise.[1] Eli Lilly developed it as a first-in-class **dual GIP/GLP-1 receptor agonist** — meaning it activates both the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor simultaneously, unlike semaglutide, which targets only GLP-1.[5] The approval was based on the SURPASS clinical trial program, which enrolled over 10,000 patients across five Phase 3 trials.[6] The second approval arrived in **November 2023**, when the FDA cleared tirzepatide as **Zepbound** for chronic weight management in adults with a BMI ≥30 kg/m², or ≥27 kg/m² with at least one weight-related comorbidity.[2] The SURMOUNT-1 trial, which enrolled 2,539 adults, showed participants on the 15 mg dose achieved a mean body weight reduction of approximately 20.9% over 72 weeks — the largest weight loss result recorded in a Phase 3 trial for any anti-obesity medication at the time of publication.[7] Both approvals are **full NDA approvals**, not accelerated approvals or breakthrough designations
