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Zepbound (tirzepatide) has been available in the United States since November 8, 2023, when the FDA approved it for chronic weight management in adults with obesity or overweight with weight-related health conditions. This dual GIP/GLP-1 receptor agonist represents a relatively new option in obesity pharmacotherapy, with just over one year of real-world clinical use. While Zepbound itself is recent, the same active ingredient was previously approved as Mounjaro for type 2 diabetes in May 2022, providing additional safety and efficacy data. Understanding Zepbound's timeline helps patients and clinicians contextualize its evidence base and post-marketing experience.
Quick Answer: Zepbound has been available since November 8, 2023, when the FDA approved it for chronic weight management in adults with obesity or overweight.
Zepbound (tirzepatide) received FDA approval for chronic weight management on November 8, 2023, making it a relatively new medication in the obesity treatment landscape. The approval was granted under the brand name Zepbound specifically for weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia.
The medication became commercially available in US pharmacies shortly after FDA approval in late November 2023, though initial supply constraints affected accessibility for some patients during the first several months after launch. Patients should be aware that Zepbound and Mounjaro contain the same active ingredient (tirzepatide) and should never be used together.
It is important to note that while Zepbound itself has been available since November 2023, the active ingredient tirzepatide was previously approved under the brand name Mounjaro for type 2 diabetes management in May 2022. This earlier approval provided substantial real-world safety and efficacy data that informed the subsequent weight management indication. The relatively recent market entry means that long-term post-marketing surveillance data beyond the clinical trial period is still accumulating, though the medication's safety profile has been extensively studied in the diabetes population.
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The clinical development program for tirzepatide as a weight management agent spanned several years before Zepbound's 2023 approval. The pivotal SURMOUNT clinical trial program began enrolling patients in 2019 and included multiple Phase 3 studies evaluating tirzepatide's efficacy and safety specifically for chronic weight management. The SURMOUNT-1 trial, published in The New England Journal of Medicine in 2022, demonstrated that tirzepatide produced substantial weight loss, with participants losing an average of 15-20% of their body weight depending on the dose used (5 mg, 10 mg, or 15 mg weekly).
Additional studies evaluated tirzepatide in specific populations, including individuals with type 2 diabetes and obesity (SURMOUNT-2), patients with obstructive sleep apnea (SURMOUNT-OSA), and those with heart failure with preserved ejection fraction (SUMMIT trial). These trials collectively enrolled thousands of participants and provided data on metabolic effects and tolerability over 72-week treatment periods.
The FDA's approval was based on robust evidence demonstrating clinically meaningful weight loss, improvements in cardiometabolic risk factors including blood pressure and lipid profiles, and an acceptable safety profile. Notably, the clinical development program for tirzepatide built upon earlier research into dual GIP/GLP-1 receptor agonism that began in the early 2010s, representing over a decade of scientific investigation into this novel mechanism.
Since its market launch in November 2023, Zepbound has been used by patients seeking effective pharmacotherapy for obesity. Real-world experience has generally aligned with clinical trial findings, with patients reporting significant weight loss when combined with lifestyle modifications including reduced-calorie diet and increased physical activity. Healthcare providers have observed that patient adherence to the once-weekly subcutaneous injection regimen tends to be favorable compared to daily medications.
Common adverse effects reported in clinical practice mirror those documented in trials, with gastrointestinal symptoms being most frequent. These include nausea (reported in 20-30% of patients), diarrhea, constipation, vomiting, and abdominal discomfort. Most gastrointestinal side effects are mild to moderate in severity and tend to diminish over time as patients acclimate to the medication. Starting at the lowest dose (2.5 mg weekly) and gradually titrating upward every four weeks helps minimize these effects.
Patients should be counseled to report persistent or severe abdominal pain (which may indicate pancreatitis or gallbladder disease), signs of dehydration or reduced urine output (potential acute kidney injury), jaundice, fever, or allergic reactions (including angioedema or anaphylaxis). Hypoglycemia risk is increased when used with insulin or sulfonylureas, which may require dose adjustments of these medications. Women using oral contraceptives should use backup contraception for 4 weeks after Zepbound initiation and after each dose increase, as the medication may reduce contraceptive effectiveness due to delayed gastric emptying.
Zepbound (tirzepatide) is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist approved for chronic weight management. It represents the first medication in its class to activate both incretin receptors simultaneously, distinguishing it from single GLP-1 receptor agonists like semaglutide. The medication is administered as a once-weekly subcutaneous injection using a pre-filled, single-dose pen injector, available in six dose strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg weekly.
The mechanism of action involves multiple pathways that contribute to weight reduction. GLP-1 receptor activation decreases appetite by acting on brain regions that regulate food intake, slows gastric emptying to promote satiety, and enhances glucose-dependent insulin secretion while suppressing inappropriate glucagon release. The additional GIP receptor agonism may further enhance insulin sensitivity and potentially augment the weight loss effects beyond GLP-1 activation alone, though the precise contribution of GIP agonism to weight loss remains an area of ongoing research.
Zepbound is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m² or greater (obesity), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition. The medication is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, and in those with serious hypersensitivity to tirzepatide or any of the product components. Zepbound is not recommended during pregnancy and should be discontinued if pregnancy occurs. Patients should be counseled about the boxed warning regarding thyroid C-cell tumors and instructed to report symptoms such as a neck mass, dysphagia, or persistent hoarseness. Treatment requires ongoing medical supervision with regular assessment of weight loss progress, tolerability, and cardiovascular risk factor improvement.
Zepbound became commercially available in US pharmacies in late November 2023, shortly after receiving FDA approval on November 8, 2023. Initial supply constraints affected accessibility for some patients during the first several months after launch.
Zepbound and Mounjaro contain the same active ingredient (tirzepatide) but are approved for different indications. Mounjaro was approved for type 2 diabetes in May 2022, while Zepbound was approved for chronic weight management in November 2023. These medications should never be used together.
The SURMOUNT clinical trial program, which began enrolling patients in 2019, provided the pivotal evidence for Zepbound's approval. These Phase 3 studies evaluated tirzepatide's efficacy and safety over 72-week treatment periods in various populations including adults with obesity and those with weight-related comorbid conditions.
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