How long has Zepbound been around? A timeline of its approval and availability

First approved by the U.S. Food and Drug Administration (FDA) on November 8, 2023, Zepbound has a relatively recent but impactful history in the field of chronic weight management. This powerful injectable, based on the active ingredient tirzepatide, has rapidly shaped the conversation around how long has Zepbound been around as an obesity treatment.

Quick Summary

Zepbound (tirzepatide) received FDA approval for chronic weight management in November 2023, though its active component was already available for diabetes. This article explores its history, from clinical trials and market launch to its dual-action pharmacology and comparative effectiveness against similar medications.

Key Points

• Recent FDA Approval: Zepbound received FDA approval for chronic weight management on November 8, 2023, making it a relatively new medication.

• Longer Active Ingredient History: Its active ingredient, tirzepatide, was first approved in May 2022 for type 2 diabetes under the brand name Mounjaro.

• Dual-Action Pharmacology: Zepbound is a dual GIP and GLP-1 receptor agonist, a unique mechanism that helps control appetite and slow digestion.

• Demonstrated Superiority: In head-to-head clinical trials, Zepbound demonstrated greater average weight loss compared to Wegovy (semaglutide).

• Initial Supply Challenges: The medication faced some supply shortages in early 2024 due to high demand, but availability has since improved.

• Alternative Formats Introduced: To address demand, Eli Lilly introduced Zepbound in single-dose vials in August 2024, in addition to the original pens.

• Additional FDA Approval: In December 2024, Zepbound also received FDA approval to treat moderate-to-severe obstructive sleep apnea in adults with obesity.

The road to Zepbound: A familiar active ingredient

While Zepbound is a new brand name, its active ingredient, tirzepatide, has been available longer. Eli Lilly and Company developed tirzepatide, which the FDA initially approved in May 2022 as Mounjaro for type 2 diabetes treatment. Observing significant weight loss in patients using Mounjaro for diabetes, Eli Lilly pursued FDA approval for weight management, leading to the development of Zepbound.

The official launch: FDA approval and initial availability

Zepbound officially entered the weight management market on November 8, 2023, when the FDA approved tirzepatide for chronic weight management in adults with obesity or those overweight with at least one weight-related condition. This approval followed positive results from the SURMOUNT clinical trial program. Zepbound became available in U.S. pharmacies in early December 2023.

Key clinical findings from Zepbound's trials:

• SURMOUNT-1: Adults without diabetes using the highest dose (15 mg) lost an average of 48 pounds (20.9% of body weight) over 72 weeks.
• SURMOUNT-2: Adults with type 2 diabetes on the highest dose (15 mg) saw an average weight reduction of 15.7% (34.4 pounds).

How Zepbound works: The dual-receptor advantage

Zepbound is effective due to its mechanism as a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. This dual action mimics two natural gut hormones, distinguishing it from weight loss drugs that only target the GLP-1 receptor. By activating both receptors, Zepbound helps reduce appetite by affecting the brain's appetite centers, slows gastric emptying for prolonged fullness, and aids in lowering blood sugar in those with type 2 diabetes by stimulating insulin and suppressing glucagon.

Zepbound vs. the competition: A head-to-head comparison

Zepbound is often compared to Wegovy, which contains semaglutide. The SURMOUNT-5 trial directly compared these two medications.

Comparison of Zepbound and Wegovy in Clinical Trials	Feature	Zepbound (Tirzepatide)	Wegovy (Semaglutide)
Mechanism	Dual GIP and GLP-1 receptor agonist	Single GLP-1 receptor agonist
FDA Approval (Weight Loss)	November 2023	June 2021
SURMOUNT-5 Trial Result	Average 20.2% weight loss over 72 weeks	Average 13.7% weight loss over 72 weeks
SURMOUNT-1/STEP 1 Trial Result	Up to 22.5% average weight loss (non-diabetic adults)	Up to 14.9% average weight loss (non-diabetic adults)
Manufacturer	Eli Lilly and Company	Novo Nordisk

Availability and supply chain challenges

High demand after launch led to initial supply issues for Zepbound in early 2024. Eli Lilly responded by increasing manufacturing and introducing single-dose vials to boost supply and offer a lower price for those without insurance. While availability has improved, it is advisable to check pharmacy stock and plan for refills in advance.

Tips for managing Zepbound availability during shortages:

• Check multiple pharmacies: Explore various pharmacies, including online options, if your usual one is out of stock.
• Order refills early: Request your prescription refill ahead of time to avoid gaps in treatment.
• Consider longer prescriptions: Discuss obtaining a two- or three-month supply with your doctor, which may also align with savings programs.
• Utilize online services: LillyDirect and Amazon Pharmacy offer online ordering and delivery.
• Stay informed: Refer to the FDA's Drug Shortages website for current information on tirzepatide availability.

Conclusion: A lasting impact on weight management

Since its FDA approval in November 2023, Zepbound has quickly impacted chronic obesity treatment. Utilizing the dual-incretin agonist tirzepatide, it has shown impressive weight loss in trials, often exceeding competitors like Wegovy. Despite early supply challenges, the manufacturer has taken steps to meet demand. With ongoing research and improving accessibility, Zepbound is set to remain a key option in medication-managed weight loss for adults with obesity and related health issues.

Frequently Asked Questions

When was Zepbound first approved by the FDA?

Zepbound was first approved by the U.S. Food and Drug Administration (FDA) for chronic weight management on November 8, 2023.

What is the difference between Zepbound and Mounjaro?

Both Zepbound and Mounjaro contain the same active ingredient, tirzepatide, but they have different FDA-approved indications. Mounjaro is approved for type 2 diabetes, while Zepbound is approved for chronic weight management.

Has Zepbound had any supply shortages?

Yes, Zepbound experienced some supply shortages, particularly in early 2024, due to high demand. However, the manufacturer increased production and availability has improved since then.

How does Zepbound work differently from other weight loss drugs?

Zepbound is a dual GIP and GLP-1 receptor agonist, meaning it mimics two different gut hormones to reduce appetite and food intake. This is distinct from drugs like Wegovy, which only mimic GLP-1.

When did Zepbound become available in pharmacies?

Following its FDA approval in November 2023, Zepbound became available in U.S. pharmacies starting in December 2023.

What were the results of the clinical trials for Zepbound?

In the SURMOUNT-1 clinical trial, adults without diabetes lost an average of up to 20.9% of their body weight on the highest dose over 72 weeks. The SURMOUNT-2 trial showed significant weight loss in adults with diabetes as well.

Was Zepbound approved for any other conditions after its initial launch?

Yes, in December 2024, the FDA approved Zepbound for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity.