Metabolic
A once-weekly GIP and GLP-1 medicine
FDA-approved · by prescriptionFDA-approved as Mounjaro and Zepbound for type 2 diabetes and chronic weight management, among other indications.
Consultations are opening state by state.
Tirzepatide is a once-weekly injectable that activates both the GIP and GLP-1 receptors. It is FDA-approved as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management. In a head-to-head trial in type 2 diabetes (SURPASS-2), it lowered A1c and body weight more than semaglutide 1 mg. Like semaglutide, it went through a multi-year national shortage with major consequences for compounding pharmacies.
Also known as Mounjaro · Zepbound · LY3298176
Y-[Aib]-EGTFTSDYSI-[Aib]-LDKIAQ-K(AEEA-AEEA-gammaGlu-C20 diacid)-AFVQWLIAGGPSSGAPPPS-NH2 (39 aa; GIP-backbone-derived)
A 39-amino-acid synthetic peptide engineered as a single-molecule dual agonist of the GIP and GLP-1 receptors. Combined incretin agonism amplifies glucose-dependent insulin secretion, suppresses glucagon, delays gastric emptying, and acts centrally to reduce appetite, producing greater weight loss than GLP-1 agonism alone.
Evidence · FDA-approved · regulatory-grade trials
In SURMOUNT-1, tirzepatide 5, 10 and 15 mg produced mean weight changes of -15.0%, -19.5% and -20.9% vs -3.1% with placebo at 72 weeks (primary treatment-regimen estimand; -16.0% to -22.5% if all participants stayed on treatment), the pivotal trial supporting Zepbound approval.
2,539 adults, BMI >=30 (or >=27 with comorbidity), SURMOUNT-1
In a head-to-head trial, all three tirzepatide doses produced superior A1c and body-weight reductions compared with semaglutide 1 mg in type 2 diabetes.
adults with T2D on metformin, SURPASS-2
FDA's Dec 19, 2024 declaratory order found the tirzepatide (Mounjaro/Zepbound) shortage resolved, revoking and replacing its Oct 2, 2024 decision, which a court had remanded to FDA at FDA's own request during compounder litigation.
n/a - US drug supply, all presentations
FDA's Dec 19, 2024 order set enforcement-discretion end dates for compounding 'essentially a copy' of tirzepatide: Feb 18, 2025 for 503A pharmacies and Mar 19, 2025 for 503B outsourcing facilities.
n/a - regulatory
FDA proposed excluding tirzepatide (with semaglutide and liraglutide) from the 503B bulks list entirely, citing no demonstrated clinical need for outsourcing-facility compounding.
n/a - rulemaking
Based on: the FDA-approved label.
Checked 2026-09
Approved use. Tirzepatide is FDA-approved as Mounjaro to improve blood-sugar control in type 2 diabetes in adults and children 10 and older and to lower the risk of major cardiovascular events in adults with type 2 diabetes at high cardiovascular risk, and as Zepbound for chronic weight management and for moderate-to-severe obstructive sleep apnea with obesity.
When consultations open, a licensed clinician in your state will review your health history and prescribe Tirzepatide only if it’s appropriate for you. A licensed U.S. pharmacy will dispense it.