Is tirzepatide approved for long-term use?: A Comprehensive Look at its Chronic Therapy Status

October 10, 2025 •

4 min read

In November 2023, the U.S. Food and Drug Administration (FDA) officially approved tirzepatide (marketed as Zepbound) for chronic weight management, directly answering the question: is tirzepatide approved for long-term use? for this specific purpose. This approval was based on robust clinical trial data showing sustained efficacy over extended periods, highlighting a significant shift towards considering obesity and related conditions as chronic diseases requiring long-term treatment.

Quick Summary

Tirzepatide is approved by the FDA for chronic use in managing type 2 diabetes and obesity. Clinical trials, including the SURMOUNT program, demonstrate that continued therapy is necessary to sustain its benefits, such as significant weight loss and improved glycemic control. The medication generally exhibits an acceptable long-term safety profile under medical supervision, despite potential side effects.

Key Points

FDA Approval for Chronic Use: Tirzepatide (Zepbound) was specifically approved by the FDA in November 2023 for chronic weight management, alongside its earlier approval (Mounjaro) for type 2 diabetes.
Maintenance Requires Continuous Treatment: Evidence from the SURMOUNT-4 trial showed that patients who stopped tirzepatide after initial weight loss regained a significant portion of their weight, demonstrating the need for continuous, long-term therapy.
Long-Term Efficacy is Proven: Multi-year clinical studies, such as the 176-week SURMOUNT-1 analysis, confirm that tirzepatide offers sustained and significant weight loss and helps prevent the progression of diabetes.
Generally Favorable Long-Term Safety Profile: The medication's safety has been established over long durations, with common gastrointestinal side effects typically manageable and decreasing over time. Regular medical monitoring is necessary.
Distinct Mechanism of Action: As a dual GIP/GLP-1 receptor agonist, tirzepatide offers a potent mechanism for regulating appetite and blood sugar, which supports lasting therapeutic results.
Obesity as a Chronic Disease: Tirzepatide's chronic approval aligns with the medical view of obesity and type 2 diabetes as long-term conditions requiring ongoing management rather than a short-term fix.

FDA Approvals for Chronic Conditions

Tirzepatide is available under two brand names with distinct primary indications, both relevant to chronic care:

Mounjaro (tirzepatide): Approved in May 2022, Mounjaro is an adjunct to diet and exercise for improving blood sugar in adults with type 2 diabetes. As type 2 diabetes is a chronic disease, Mounjaro is intended for long-term therapy.
Zepbound (tirzepatide): Approved in November 2023, Zepbound is indicated for chronic weight management in adults with obesity or overweight with a weight-related comorbidity. This approval specifically allows for the long-term, chronic use of tirzepatide for weight management.

Evidence for Long-Term Efficacy and Maintenance

Clinical trial data, particularly from the SURMOUNT program, supports the need for long-term tirzepatide use to maintain benefits.

The SURMOUNT-4 Trial

In the SURMOUNT-4 trial, participants with obesity initially received tirzepatide for 36 weeks and achieved substantial weight loss. When randomized to continue tirzepatide or switch to placebo for another 52 weeks, those who continued maintained and slightly increased their weight loss, while the placebo group regained a significant amount of weight. This highlights that continuous treatment is crucial for sustaining effects.

The SURMOUNT-1 3-Year Analysis

A 3-year analysis of the SURMOUNT-1 trial involving adults with pre-diabetes and obesity demonstrated that 176 weeks of sustained tirzepatide treatment maintained significant weight loss and prevented progression to type 2 diabetes in almost all participants.

The Long-Term Safety Profile of Tirzepatide

Long-term safety data from the SURPASS and SURMOUNT programs characterizes tirzepatide's safety over extended periods.

Common Side Effects

Common side effects are primarily gastrointestinal and often occur during initial dose increases, including nausea, diarrhea, vomiting, and constipation. These are usually mild to moderate and decrease over time. Discontinuation due to side effects is relatively infrequent.

Rare and Serious Side Effects

Tirzepatide has a boxed warning about a potential risk of thyroid C-cell tumors based on animal studies, although it's unclear if this applies to humans. It should not be used in patients with a history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. Other rare but serious side effects can include pancreatitis, gallbladder issues, severe allergic reactions, and kidney problems. Regular medical monitoring is important for managing potential side effects and ensuring long-term safety and effectiveness.

How Tirzepatide Works for Lasting Results

Tirzepatide's action as the first GIP and GLP-1 receptor agonist mimics natural gut hormones, impacting metabolic functions through:

Appetite Regulation: Reducing appetite and increasing fullness.
Blood Sugar Control: Promoting insulin release when blood sugar is high and reducing liver glucose production.
Gastric Emptying: Slowing stomach emptying, contributing to satiety.

These combined effects support sustainable weight loss and improved glycemic control over time.

Comparing Tirzepatide to Other Long-Term Treatments


Feature	Tirzepatide (Zepbound/Mounjaro)	Semaglutide (Wegovy/Ozempic)	Other GLP-1 Agonists	Bariatric Surgery
Mechanism	Dual GIP/GLP-1 Receptor Agonist	GLP-1 Receptor Agonist	GLP-1 Receptor Agonists (e.g., dulaglutide)	Anatomical modification of digestive system
FDA Status	Chronic weight management (Zepbound) and type 2 diabetes (Mounjaro).	Chronic weight management (Wegovy) and type 2 diabetes (Ozempic).	Approved for type 2 diabetes; some may be used off-label for weight loss.	Surgical procedure, not a medication.
Long-Term Data	Robust data up to 176 weeks, showing sustained weight loss.	Extensive long-term data, including large cardiovascular outcome trials.	Varies by specific agent; generally has solid long-term safety profiles in diabetes.	Long-standing evidence for sustained, significant weight loss.
Efficacy	Highly effective, with studies showing significant weight reduction (~21-25% in clinical trials).	Also highly effective, with slightly less average weight loss compared to tirzepatide in trials (~15-17%).	Efficacy levels can vary; generally less potent for weight loss than tirzepatide and semaglutide.	Considered the most effective intervention for weight loss, though invasive.
Administration	Once-weekly subcutaneous injection.	Once-weekly subcutaneous injection for most indications.	Once-weekly (dulaglutide) or daily (liraglutide) subcutaneous injection.	One-time procedure, but with potential for re-operations.
Risks	Boxed warning for thyroid C-cell tumors; risk of pancreatitis, gallbladder issues.	Boxed warning for thyroid C-cell tumors; risk of pancreatitis, gallbladder issues.	Boxed warnings and risks vary by agent.	Surgical risks including bleeding, infection, and nutritional deficiencies.

Conclusion: The New Standard in Chronic Care

Yes, tirzepatide is approved for long-term use in managing type 2 diabetes and chronic weight management. The FDA’s approval for chronic weight management highlights the understanding of obesity as a chronic disease requiring ongoing treatment. Clinical trials demonstrate significant efficacy in maintaining weight loss and improving metabolic health with continuous use. While common gastrointestinal side effects occur, the overall safety profile supports long-term therapy under medical supervision. Tirzepatide is a valid option for chronic care in eligible patients.

For more information on the FDA approval of tirzepatide for chronic weight management, you can read the official press release on the FDA website.

Frequently Asked Questions

For chronic conditions like obesity and type 2 diabetes, patients often remain on tirzepatide indefinitely to maintain treatment benefits. Clinical trials have studied continuous use for up to 176 weeks (3+ years), showing maintained efficacy.

Clinical trial data from the SURMOUNT-4 study showed that many patients who discontinued tirzepatide therapy experienced significant weight regain. Continued use is typically necessary to sustain the weight loss and other metabolic improvements achieved.

Based on available clinical data, tirzepatide has an acceptable long-term safety profile when used under medical supervision. Side effects are typically most frequent and prominent at the beginning of therapy during dose escalation.

The most common side effects are gastrointestinal (nausea, diarrhea, constipation), which tend to be mild or moderate and improve over time. Other potential long-term effects include risks related to the pancreas and gallbladder, requiring ongoing monitoring.

While tirzepatide carries a boxed warning based on a risk of thyroid C-cell tumors in rodents, it is not known if this risk applies to humans. It is contraindicated in patients with a history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

By activating both GIP and GLP-1 receptors, tirzepatide helps maintain weight loss by suppressing appetite and increasing satiety, which counteracts the body's hormonal signals that drive weight regain after dieting.

Yes, regular medical monitoring is essential for long-term use. This includes assessing for side effects, monitoring overall health (including metabolic and GI parameters), and potentially adjusting dosage based on tolerance and treatment goals.