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Is tirzepatide FDA approved for weight loss?
Executive summary
Yes — the FDA has approved tirzepatide (branded as Zepbound) for chronic weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight‑related condition; the approval was announced November 8, 2023 (FDA and Eli Lilly) [1] [2]. Pivotal SURMOUNT trials showed large mean weight losses (e.g., ~18% in people without diabetes at higher doses and up to ~20% in some reports), which the FDA cited in its decision [3] [4].
1. FDA approval: what was approved and when
The FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at least one weight‑related condition on November 8, 2023 — the agency’s press release and Eli Lilly’s announcement both state this indication and date [1] [2]. Multiple clinical and trade outlets reported the same approval and the approved indication tied to diet and increased physical activity [3] [5].
2. Who qualifies under the FDA label
Under the FDA labeling, Zepbound is indicated for adults with a BMI of 30 kg/m² or greater (obesity) or a BMI of 27 kg/m² or greater (overweight) with at least one weight‑related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia — the FDA announcement and summaries of the approval make this explicit [1] [6].
3. Why the FDA approved it: trial evidence and magnitude of weight loss
The approval was based primarily on the SURMOUNT program, notably SURMOUNT‑1 (adults without diabetes) and SURMOUNT‑2 (with diabetes). Published summaries and reporting say participants on higher doses lost on average roughly 15–20% of body weight at 72 weeks, with some summaries citing ~18% and others reporting up to ~20.9% in the highest dose group — figures referenced by Healio, Time, and trial summaries cited by the FDA [4] [7] [3].
4. Safety warnings, common side effects and limits of knowledge
Labeling and reporting note common gastrointestinal adverse events (nausea, diarrhea, vomiting, constipation) and other reactions such as injection‑site reactions and hair loss; the label also carries a boxed warning about thyroid C‑cell tumors observed in rats and contraindications for patients with a personal or family history of medullary thyroid carcinoma or MEN2 [3] [2]. The FDA and company statements also caution that co‑administration with other GLP‑1 agents has not been established as safe or effective [2] [5].
5. Relation to diabetes formulations and off‑label use
Tirzepatide was already marketed as Mounjaro for type 2 diabetes; Zepbound uses the same active ingredient but is the FDA‑approved brand and indication for chronic weight management. Reporting and FDA notes distinguish the previously approved diabetes indication from the new weight‑management approval [1] [2]. Earlier to the weight‑management approval, tirzepatide was used off‑label for weight loss; StatPearls notes its efficacy led to off‑label obesity use prior to the formal weight‑loss approval [8].
6. Commercial context, access and pricing considerations
Eli Lilly announced Zepbound’s approval and planned commercial rollout; press coverage mentions an expected list price and Lilly programs to improve access, while other outlets highlighted demand and shortages across weight‑loss medications as context for the approval [2] [9] [3]. Available sources do not provide a comprehensive, current account of payer coverage or real‑world availability beyond those commercial statements (not found in current reporting).
7. Competing viewpoints and remaining questions
Medical reporting framed the approval as a major advance because of larger weight‑loss magnitudes compared with older agents [5] [7]. Some coverage places the results in the context of long‑term management questions — e.g., weight regain after discontinuation seen in trials and the need for long‑term safety data — and notes that cardiovascular outcome trials are ongoing [10] [4]. Sources differ in exact percentage figures cited for mean weight loss (ranging ~15–21% in different summaries), reflecting differences across trials, doses, and how numbers were rounded in reporting [4] [7] [10].
8. Bottom line for patients and clinicians
For adults meeting the BMI and comorbidity criteria, tirzepatide (Zepbound) is FDA‑approved as a prescription option for chronic weight management in combination with lifestyle measures [1] [2]. Clinicians and patients should weigh the substantial efficacy shown in SURMOUNT trials against known side effects, the boxed thyroid warning, contraindications, and uncertainties about long‑term outcomes; all of these points are emphasized in FDA and medical reporting [3] [2].
Limitations: This summary relies solely on the provided documents, which primarily cover the FDA approval announcements, trial toplines and company material; payer coverage decisions, up‑to‑date supply/availability or post‑marketing safety developments beyond those sources are not covered here (not found in current reporting).