by Vaibhavi M.

6 minutes

All You Need to Know About Compounded Terzepatide

Discover the complexities of compounded tirzepatide, its benefits, risks, and how it addresses shortages in type 2 diabetes treatment.

All You Need to Know About Compounded Terzepatide

Tirzepatide is a newly famous drug for its efficiency in treating type 2 diabetes and contribution to weight loss. Its success has led to the existence of compounded versions, which are available to patients during challenges. However, compounded tirzepatide comes with its own set of complexities and considerations. Pharma Now will provide you answers to all the questions about compounded tirzepatide. 


What is Tirzepatide? 

Tirzepatide is the main component of brand names like Mounjaro and Zepbound, two other drugs approved by the FDA and produced by Eli Lilly. Tirzepatide is a dual agonist for the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. 

The drug leads to significantly improved glycemic control and weight reduction in patients with type 2 diabetes mellitus, maximizing benefits similar to GLP-1 medications such as semaglutide.


Mechanism Of Tirzepatide 

Tirzepatide is a synthetic polypeptide dual agonist for GLP-1 and GIP. The medication comprises 39 amino acids and is an analogue of the gastric inhibitory polypeptide (GIP). Functionally, tirzepatide stimulates insulin release from the pancreas and reduces hyperglycemia. In addition, tirzepatide also increases the levels of adiponectin. The dual agonism ability decreases hyperglycemia significantly more than GLP-1 agonist agents and reduces the patient's appetite.


Why Compounded Tirzepatide? 

Tirzepatide, when compounded, became immensely popular during the short supply of FDA-approved versions during the COVID-19 pandemic. The reason that compounding pharmacies began to develop tirzepatide preparations is that they can be personalised to some patient characteristics. These were particularly appealing due to: 

Lower Costs: There is a view that compounded versions are cheaper as compared to branded products.

Availability: They provided a solution during the disruptions of the FDA drug Tirzepatide supply chain.

Customization: The preparations could be bent according to the patient’s needs.


The Risks of Compounded Tirzepatide

Even if it's compounded, it comes with a risk.

Lack of FDA Approval: Tirzepatide is a substance not approved by the FDA for compound use, and there is distrust regarding its quality, safety and effectiveness.

Variable Quality: Compounded medications, thus, might have different potency and could be less pure than branded drugs.

Regulatory Crackdown: Now that the shortage of tirzepatide is over, the FDA has released guidelines restricting compounding pharmacies from manufacturing the drug. 


The Reason For the Rise In Demand

Compounded tirzepatide is relatively cheaper than other brands and thus easily accessible. Although, this aspect should be considered by the patient and the healthcare provider, being conscious that the FDA does not accredit such medications and may actually have some certain risks to the patient. In most cases, it is based on factors such as availability of branded drugs, family/national budgets and health states.


Future Of Compounded Tirzepatide

The demand for compounded versions of tirzepatide is anticipated to decrease as the shortage reduces and access to FDA-approved drugs improves. However, the circumstance highlights the significance of strong pharmaceutical supply chains and the function of compounding in meeting unmet demands in emergency situations.


Legality of Compound Tirzepatide 

Eli Lilly, the original developer of tirzepatide, has actively defended its intellectual property rights:

The firm has become a part of legal cases against compounding pharmacies that are manufacturing bogus tirzepatide.

In particular, FDA underlines that the use of compounded tirzepatide must be justified by several conditions, among which drug shortages are no longer valid.

 

Conclusion

Tirzepatide is available in classic compounded form during periods of shortages, thus being capable of filling this cavity, though with many compromises on its benefits. As availability increases, patients opt to use those recommended by the FDA as there is confidence in the drugs’ quality. Large pharma companies such as Eli Lilly are improving their supply chain capability, which means that attention is now being rightfully turned back towards providing superior, reliable healthcare goods.

Being aware of the features of compounded medications can help patients become knowledgeable about the cost, risks, and benefits of improving their health.


FAQs

1. Is compounded tirzepatide safe?

While it may be effective, compounded tirzepatide lacks FDA approval, posing potential safety and quality concerns.

2. Why is Eli Lilly taking legal action?

To protect its intellectual property(IP) and ensure that patients use FDA-approved, high-quality medications.

3. Are compounded versions cheaper?

Yes, but the lower cost comes with increased quality consistency and potency risks.

What should I do if I’ve been using compounded tirzepatide?

Speak with your healthcare provider about transitioning to an FDA-approved alternative.

Author Profile

Vaibhavi M.

Associate Content Writer

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Author Profile

Vaibhavi M.

Associate Content Writer

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