FDA Changes To Tirzepatide: What Does It Mean?

GLP-1 medications for weight loss have quickly risen in popularity in the past few years, which has caused limited availability of some ingredients. After two years, tirzepatide has recently been removed from the Food and Drug Administration (FDA) drug shortage list, but what does that mean for patients? Our experts break down the tirzepatide shortage, what happens now manufacturers can meet demand and if there are any alternatives to tirzepatide you can take. 

What is tirzepatide?

Tirzepatide is a dual action GIP receptor and GLP-1 receptor agonist medication. This means that, unlike other weight loss drugs, it mimics the action of two different gut hormones: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It was originally developed to help people with type-2 diabetes regulate their blood sugar, but now it's prescribed to aid weight loss by decreasing hunger and increasing feelings of fullness. [1] Tirzepatide is the name of the active ingredient, but you may know it better by its brand name: Mounjaro. 

Tirzepatide shortages 

Tirzepatide was added to the FDA drug shortage list in December 2022, less than one year after it was approved for use in patients with type-2 diabetes. [2] This came after Eli Lilly, the drug's manufacturer, became unable to keep up with the unprecedented demand for tirzepatide. 

During a national shortage, the FDA temporarily allows drug manufacturers to produce compounded versions of medications --- in this case, these are medically equivalent to tirzepatide products and don't have to be approved by the FDA. [3] Compounded pharmaceutical ingredients are safe as long as they're produced in state-licensed compounding pharmacies that are regularly inspected and meet the highest quality standards.

FDA changes

In October 2024, the FDA confirmed Eli Lilly's manufacturing capacity can meet current and future national demand for tirzepatide, so the drug was removed from the drug shortage list. [2]  Some healthcare providers may experience supply disruptions in their areas, however, as they wait for tirzepatide products to move through the supply chain. 

This also, crucially, means that drug manufacturers and compounding pharmacies are no longer allowed to produce and sell unbranded copies of tirzepatide. So, anybody who started tirzepatide injections from a compounding pharmacy may now lose access to their treatment as Eli Lilly takes legal action to prevent manufacturers from creating them. [4] This also means people are forced to purchase more expensive, branded versions of tirzepatide, rather than cheaper compounded medications.

Compounded Semaglutide as an alternative to tirzepatide 

Compounded medications are growing in popularity because they're available at more affordable prices, since they're not associated with a premium brand name. Semaglutide is another popular weight loss medication that belongs to the GLP-1 drug class. Like tirzepatide, it targets your brain's hunger center [5] and slows gastric emptying [6] to increase feelings of fullness. Compounded Semaglutide is still available as it hasn't been affected by the same supply issues, so providers like Levity can continue to produce and prescribe it to people who need it. 

With a Compounded Semaglutide treatment plan, you could lose up to 15% of your body weight. [7]

Start your weight loss journey now

Considering trying a weight loss medication to help you reach your weight goals? Start a consultation with our clinicians today to see if you're eligible. 

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Disclaimer: The information in this blog post may be subject to change. On 10/22/24, the FDA issued the following update: "As part of litigation, the decision to remove tirzepatide from the FDA drug shortage list has been remanded to the agency for reevaluation. FDA sent a letter on October 17, 2024, in response to a question regarding the agency’s intended approach to the compounding of tirzepatide drug products during the reevaluation period."

This means we're awaiting further updates on the future availability of compounded tirzepatide products. All information is accurate at the time of writing.

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References: 

1. Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine [Internet]. 2022 Jun 4;387(3). Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2206038 

2. Center. CDER Statement [Internet]. U.S. Food and Drug Administration. 2024. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize 

3. Center. Compounding when Drugs are on FDA’s Drug Shortages List [Internet]. U.S. Food and Drug Administration. 2024. Available from: https://www.fda.gov/drugs/human-drug-compounding/compounding-when-drugs-are-fdas-drug-shortages-list 

4. Wingrove P. Lilly sues online vendors, medical spa over copycat weight-loss drugs [Internet]. Reuters. 2024 [cited 2024 Oct 24]. Available from: https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-sues-online-vendors-medical-spa-over-copycat-weight-loss-drugs-2024-10-21/ 

5. Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, et al. Effects of once‐weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes, Obesity and Metabolism [Internet]. 2017 May 5;19(9):1242–51. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5573908/ 

6. Wilding JPH, Batterham RL, Calanna S. Once-Weekly Semaglutide in Adults with Overweight or Obesity. The New England Journal of Medicine [Internet]. 2021 Feb 10;384(11):989–1002. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2032183 

7. Chronic Weight Results | Wegovy® (semaglutide) injection 2.4 mg [Internet]. novoMEDLINK. 2023 [cited 2024 Oct 11]. Available from: https://www.novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/chronic-weight-management.html#wegovy-and-significant-weight-loss