● TIER 1 — FDA-approved / recognizedGRADE AGLP-1 / incretins & amylin
Tirzepatide
GIP/GLP-1 dual agonist. Research verification: Yes (TGA pending). 3 human study record(s) in the FitClinicMD studies database.
GOALS · Weight loss
FDA status
Approved: Mounjaro (T2D), Zepbound (obesity; moderate-severe OSA with obesity).
Compounding (503A/503B)
Shortage resolved (declaratory order Dec 19 2024); 503A/503B discretion ended Mar 19 2025
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
Dual GIP/GLP-1R agonist; t½ ~5 d.
Human evidence · 3
OSA+obesity: AHI reduction, basis of OSA indication. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.
n=2,539, 72 wk: −20.9% (15 mg) vs −3.1%. Tirzepatide Once Weekly for the Treatment of Obesity.
T2D, n=1,879: superior HbA1c and weight vs semaglutide 1 mg. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.
Reference only. This page summarizes publicly available regulatory and research information about Tirzepatide. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.