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Zepbound Regulatory Status: US, EU, Canada, and UK Approvals for Tirzepatide

By
Terry Dubrow, MD

Medically reviewed by Terry Dubrow, MD

Founder and Chief Medical Officer · Board certified in obesity medicine

Published Updated
5 linked public sourcesEditorial, sourcing, and corrections policy

HealthRX.com

Zepbound is FDA approved for weight and sleep apnea

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Key numbers

  • 15 mgMaximum weekly Zepbound dose for any indication, including sleep apneaSource: dailymed.nlm.nih.gov, as cited Nov 7, 2026
  • 2.5 mgStarting dose taken once weekly for 4 weeks, for initiation onlySource: dailymed.nlm.nih.gov, as cited Nov 7, 2026
  • -5.5%Weight change from week 36 to week 88 in SURMOUNT-4 patients who continued tirzepatideSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026

See the public record for Tirzepatide

At a glance

  • FDA approval / November 8, 2023, for chronic weight management [2]
  • Second indication / Moderate-to-severe obstructive sleep apnea in adults with obesity [1]
  • Drug class / Dual GIP and GLP-1 receptor agonist [1]
  • Route / Once-weekly subcutaneous injection [1]
  • Maintenance doses / 5, 10 or 15 mg weekly; 10 or 15 mg for OSA; maximum 15 mg [1]
  • Boxed warning / Thyroid C-cell tumors [1]

What the FDA approved

The FDA approved Zepbound (tirzepatide) injection on November 8, 2023 for chronic weight management in adults with a body-mass index of 30 or higher, or 27 or higher with at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol, in addition to a reduced-calorie diet and increased physical activity [2].

The current label lists two indications: to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight plus at least one weight-related comorbid condition, and to treat moderate-to-severe obstructive sleep apnea in adults with obesity [1]. The label states that coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended, and that safety and effectiveness in pediatric patients have not been established [1].

Questions worth asking

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What the approval was based on

Effectiveness was established in two randomized, double-blind, placebo-controlled trials that measured weight reduction at 72 weeks in 2,519 patients given Zepbound and 958 given placebo [2].

In SURMOUNT-1, 2,539 adults with a BMI of 30 or higher, or 27 or higher plus a weight-related complication and no diabetes, lost a mean 15.0% (5 mg), 19.5% (10 mg) and 20.9% (15 mg) of body weight at 72 weeks, against 3.1% with placebo [3]. SURMOUNT-2 enrolled 938 adults with a BMI of 27 or higher and type 2 diabetes [4].

In SURMOUNT-4, 783 adults received open-label tirzepatide for 36 weeks. At week 36, 670 participants were randomized: 335 continued tirzepatide and 335 switched to placebo. The 670 had a mean weight reduction of 20.9% at that point, and from week 36 to week 88 weight changed by -5.5% in those who continued tirzepatide and +14.0% in those who switched to placebo [5].

Doses the label approves

Zepbound starts at 2.5 mg once weekly for 4 weeks; the label states that 2.5 mg is for treatment initiation and is not approved as a maintenance dose [1]. The dose then rises to 5 mg and can increase in 2.5 mg steps after at least 4 weeks on the current dose [1]. Maintenance is 5, 10 or 15 mg weekly for weight reduction and 10 or 15 mg weekly for obstructive sleep apnea, with 15 mg weekly the maximum for any indication [1].

The boxed warning

Zepbound carries a boxed warning for thyroid C-cell tumors. In rats, tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures, and whether it causes such tumors, including medullary thyroid carcinoma, in humans is unknown [1]. The label contraindicates Zepbound in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [1].

Check what you know

Think you have it? Try 3 quick questions and see what the article says.

1. According to the article, which of these is one of Zepbound's two current label indications?

Question 1 of 3

Score: 0 right, 0 of 3 answered

Frequently asked questions

Is Zepbound FDA approved?
Yes. The FDA approved it on November 8, 2023 for chronic weight management in adults with a BMI of 30 or higher, or 27 or higher with at least one weight-related condition [2]. The current label also covers moderate-to-severe obstructive sleep apnea in adults with obesity [1].
What is Zepbound approved to treat?
Two uses, each with a reduced-calorie diet and more physical activity: reducing excess body weight and maintaining weight reduction long term in adults with obesity or overweight plus a weight-related condition, and moderate-to-severe obstructive sleep apnea in adults with obesity [1].
How does Zepbound differ from Mounjaro?
They are separate FDA-approved products with different indications. Mounjaro is approved for type 2 diabetes in adults and in children 10 and older, and to reduce the risk of major cardiovascular events in adults with type 2 diabetes at high risk. It is not labeled for weight loss. Weight management and obstructive sleep apnea are Zepbound indications [1].
What doses of Zepbound are approved?
2.5 mg once weekly for 4 weeks as an initiation dose, then 5 mg, with 2.5 mg steps after at least 4 weeks on each dose. Maintenance is 5, 10 or 15 mg for weight reduction and 10 or 15 mg for OSA, with 15 mg weekly as the maximum [1].
What is Zepbound's boxed warning?
Thyroid C-cell tumors occurred in rats at clinically relevant exposures, and human relevance is unknown. The label contraindicates use in patients with a personal or family history of medullary thyroid carcinoma or MEN 2 [1].

References

Show all 5 referencesHide references
  1. U.S. National Library of Medicine, DailyMed. Zepbound injection (tirzepatide) prescribing information. Zepbound injection (tirzepatide) label
  2. FDA Approves New Medication for Chronic Weight Management | FDA.
  3. Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022;387(3):205-216.
  4. Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613-626.
  5. Aronne LJ, Sattar N, Horn DB, Bays HE, Wharton S, Lin WY, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024;331(1):38-48.
Evidence overview for Zepbound Regulatory Status: US, EU, Canada, and UK Approvals for Tirzepatide