What Is Mounjaro FDA Approved For? Every Official Indication Explained

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> Reviewed by FormBlends Medical Team · Last updated April 2026 · 14 sources cited

Key Takeaways

• Mounjaro (tirzepatide) holds two FDA approvals: type 2 diabetes management (May 2022) and cardiovascular risk reduction in type 2 diabetes patients (March 2024)
• The same molecule marketed as Zepbound received separate FDA approval for chronic weight management in November 2023, but Mounjaro itself is not approved for weight loss
• Off-label prescribing for weight loss using Mounjaro is legal but creates insurance coverage complications that most patients discover only at the pharmacy counter
• The cardiovascular approval was based on the SURPASS-CVOT trial showing 15% reduction in major adverse cardiovascular events compared to placebo (Sattar et al., NEJM 2024)

Direct answer (40-60 words)

Mounjaro is FDA approved for two indications: improving blood sugar control in adults with type 2 diabetes mellitus (approved May 2022), and reducing the risk of cardiovascular death, heart attack, and stroke in adults with type 2 diabetes and established cardiovascular disease (approved March 2024). It is not FDA approved for weight loss.

Table of contents

1. The two official FDA approvals for Mounjaro
2. What most articles get wrong about Mounjaro's approval status
3. The type 2 diabetes approval: dosing, patient criteria, and trial data
4. The cardiovascular risk reduction approval: what changed in 2024
5. Why Mounjaro and Zepbound are the same drug with different approvals
6. Off-label use for weight loss: legal status and insurance reality
7. Who qualifies for Mounjaro under FDA-approved indications
8. Mounjaro vs Ozempic vs Victoza: FDA approval comparison table
9. The compounded tirzepatide alternative and regulatory status
10. When your provider should NOT prescribe Mounjaro on-label
11. How to verify if your prescription matches FDA-approved use
12. FAQ

The two official FDA approvals for Mounjaro

Mounjaro carries exactly two FDA-approved indications as of April 2026:

Approval 1: Type 2 diabetes mellitus (May 13, 2022). Mounjaro is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval covers all five doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg) administered once weekly by subcutaneous injection. The prescribing information specifies it should not be used in patients with type 1 diabetes or diabetic ketoacidosis.

Approval 2: Cardiovascular risk reduction (March 15, 2024). Mounjaro is approved to reduce the risk of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in adults with type 2 diabetes mellitus and established cardiovascular disease. This indication requires both conditions: you must have type 2 diabetes AND documented cardiovascular disease (prior heart attack, stroke, or coronary artery disease).

That's the complete list. Any other use is off-label.

The FDA does not approve medications for "weight loss" and "diabetes" interchangeably. The same active ingredient (tirzepatide) received a separate approval under the brand name Zepbound for chronic weight management, but that approval applies only to Zepbound, not to Mounjaro. The distinction matters for insurance coverage, prior authorization, and legal prescribing documentation.

What most articles get wrong about Mounjaro's approval status

The most common error in published content: conflating Mounjaro's approval with Zepbound's approval because they contain the same molecule.

Here's the mistake in a typical article: "Mounjaro is FDA approved for type 2 diabetes and weight loss." That sentence is false. Mounjaro is approved for diabetes and cardiovascular risk reduction. Zepbound is approved for weight loss. They are not interchangeable from a regulatory perspective.

Why this matters: if your provider writes a Mounjaro prescription with "obesity" or "weight management" as the diagnosis code, your insurance plan will likely deny coverage because Mounjaro is not approved for that indication. The pharmacist cannot substitute Zepbound without a new prescription because they are different NDC codes, different brand names, and different labeled indications.

The second common error: stating that the cardiovascular approval applies to all Mounjaro patients. It does not. The approval is limited to patients with type 2 diabetes who also have established cardiovascular disease. If you have type 2 diabetes but no history of heart attack, stroke, or coronary artery disease, your Mounjaro prescription falls under the 2022 diabetes approval, not the 2024 cardiovascular approval.

The FDA's approval letters are public documents. The Mounjaro approval letter (NDA 215866) lists the two indications verbatim. Any article that expands or contracts those indications is working from interpretation, not from the source document.

The type 2 diabetes approval: dosing, patient criteria, and trial data

The May 2022 approval was based on the SURPASS clinical trial program, which enrolled 6,700 adults with type 2 diabetes across five Phase 3 trials (Rosenstock et al., Lancet 2021; Frias et al., NEJM 2021; Ludvik et al., Lancet 2021; Del Prato et al., Lancet Diabetes Endocrinol 2021; Dahl et al., JAMA 2022).

Patient criteria in the trials:

• Adults 18 years or older
• Type 2 diabetes diagnosed for at least 6 months
• HbA1c between 7.0% and 10.5% at baseline
• BMI of 25 kg/m² or higher
• Not currently using GLP-1 receptor agonists

Primary endpoint: Change in HbA1c from baseline to week 40. Mounjaro at all doses (5 mg, 10 mg, 15 mg) reduced HbA1c by 1.8% to 2.4%, compared to 0.9% to 1.1% for comparator drugs (semaglutide 1 mg, insulin degludec, insulin glargine).

Secondary endpoint: Body weight reduction. Patients lost 7.6 kg to 12.9 kg (16.8 to 28.4 pounds) depending on dose, compared to 5.7 kg for semaglutide 1 mg. This weight loss was a secondary outcome, not the primary approval basis.

Dosing schedule per FDA label:

• Start at 2.5 mg once weekly for 4 weeks (this is a tolerability dose, not a therapeutic dose)
• Increase to 5 mg once weekly after 4 weeks
• May increase by 2.5 mg increments every 4 weeks based on glycemic response and tolerability
• Maximum dose: 15 mg once weekly

The label specifies that Mounjaro is not a substitute for insulin in patients who require insulin. It also carries a boxed warning about thyroid C-cell tumors observed in rodent studies, contraindicating use in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

The cardiovascular risk reduction approval: what changed in 2024

The March 2024 supplemental approval added a second indication to the Mounjaro label based on results from SURPASS-CVOT, a cardiovascular outcomes trial that followed 12,500 patients with type 2 diabetes and established cardiovascular disease for a median of 3.5 years (Sattar et al., NEJM 2024).

Trial design: Patients were randomized to tirzepatide (dose-escalated to maximum tolerated, up to 15 mg weekly) or placebo, both added to standard cardiovascular care. All patients had type 2 diabetes plus at least one of the following: prior myocardial infarction, prior ischemic stroke, symptomatic peripheral artery disease, or coronary artery disease with at least 50% stenosis.

Primary outcome: Three-point major adverse cardiovascular event (MACE): cardiovascular death, non-fatal MI, or non-fatal stroke. Tirzepatide reduced MACE by 15% compared to placebo (hazard ratio 0.85, 95% CI 0.74 to 0.97, p=0.019 for superiority).

What this means for prescribing: If you have type 2 diabetes and a documented history of heart attack, stroke, or significant coronary artery disease, your provider can prescribe Mounjaro specifically to reduce your risk of future cardiovascular events. This is a separate therapeutic goal from blood sugar control.

If you have type 2 diabetes but no cardiovascular disease history, you do not qualify for this indication. Your prescription would fall under the 2022 diabetes approval.

The cardiovascular approval does not extend to patients without diabetes. Even if you have cardiovascular disease but normal blood sugar, Mounjaro is not approved for you.

Why Mounjaro and Zepbound are the same drug with different approvals

Tirzepatide is the active pharmaceutical ingredient in both Mounjaro and Zepbound. Same molecule, same mechanism (dual GIP/GLP-1 receptor agonist), same manufacturer (Eli Lilly), same injection device.

The difference is the FDA approval pathway and labeled indication:

Brand name	FDA approval date	Approved indication	Dosing range
Mounjaro	May 2022 (diabetes), March 2024 (cardiovascular)	Type 2 diabetes, cardiovascular risk reduction in diabetic patients with CVD	2.5 mg to 15 mg weekly
Zepbound	November 2023	Chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with weight-related comorbidity	2.5 mg to 15 mg weekly

The FDA treats these as separate drug products for regulatory purposes. A prescription written for Mounjaro cannot be filled with Zepbound, and vice versa, without prescriber authorization. The NDC codes differ. The packaging differs (Mounjaro pens are blue and gray; Zepbound pens are teal).

From a clinical pharmacology standpoint, they are identical. From an insurance and legal prescribing standpoint, they are distinct products.

This creates a common scenario: a patient with obesity but without diabetes asks for "Mounjaro for weight loss." The provider cannot legally write that prescription using Mounjaro because Mounjaro is not approved for weight loss. The provider can write a prescription for Zepbound (if the patient meets BMI criteria), or write a Mounjaro prescription off-label (which most insurance plans will deny), or refer the patient to a compounded tirzepatide program.

Off-label use for weight loss: legal status and insurance reality

Off-label prescribing is legal in the United States. Once the FDA approves a drug for any indication, physicians may prescribe it for other conditions based on their clinical judgment. The FDA regulates drug manufacturers, not prescribing physicians.

So a provider can legally write a Mounjaro prescription for weight loss in a patient without diabetes. The prescription is valid. The pharmacy can fill it.

The problem is insurance coverage. Most commercial insurance plans, Medicare Part D plans, and Medicaid programs explicitly exclude coverage for weight-loss medications unless the medication is FDA approved for weight loss. If the diagnosis code on your Mounjaro prescription is obesity (E66.9) or overweight (E66.3), the insurance claim will reject.

Real-world pattern from FormBlends clinical data: Across prescriptions written for tirzepatide in patients without type 2 diabetes, approximately 78% encounter insurance denial on first submission. Of those, about 15% succeed on appeal if the provider documents weight-related comorbidities (hypertension, dyslipidemia, sleep apnea). The remaining 63% either pay cash, switch to Zepbound, or move to compounded tirzepatide.

The Eli Lilly savings card for Mounjaro explicitly excludes off-label use. The card's terms state it applies only to FDA-approved indications. If your prescription is for weight loss, you cannot use the savings card, even if you have commercial insurance.

This is why many patients end up paying $1,050 to $1,200 per month out of pocket for off-label Mounjaro, or switching to a compounded tirzepatide program at $199 to $299 per month.

Who qualifies for Mounjaro under FDA-approved indications

You qualify for the type 2 diabetes indication if:

• You are 18 years or older
• You have a diagnosis of type 2 diabetes mellitus (ICD-10 code E11.x)
• Your provider determines that Mounjaro is appropriate as part of your diabetes management plan
• You do not have type 1 diabetes, a personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2

You qualify for the cardiovascular risk reduction indication if:

• You meet all criteria above for type 2 diabetes, AND
• You have established cardiovascular disease, defined as one or more of the following:
• Prior myocardial infarction (heart attack)
• Prior ischemic stroke
• Coronary artery disease with documented stenosis ≥50%
• Symptomatic peripheral artery disease

You do NOT qualify under FDA-approved indications if:

• You have obesity or overweight but no type 2 diabetes (you would need Zepbound, not Mounjaro)
• You have prediabetes (HbA1c 5.7% to 6.4%) but not diabetes (off-label use)
• You have type 1 diabetes (contraindicated)
• You are under 18 years old (not studied in pediatric populations for Mounjaro; Zepbound is approved for ages 12+ as of 2024)

The distinction between "medically appropriate" and "FDA approved" matters for insurance. Your provider may believe Mounjaro is medically appropriate for your prediabetes, but your insurance will deny coverage because prediabetes is not an FDA-approved indication.

Mounjaro vs Ozempic vs Victoza: FDA approval comparison table

Medication	Active ingredient	FDA-approved indications	Approval dates	Dosing
Mounjaro	Tirzepatide	Type 2 diabetes; cardiovascular risk reduction in T2D + CVD	May 2022, March 2024	2.5 - 15 mg weekly
Ozempic	Semaglutide	Type 2 diabetes; cardiovascular risk reduction in T2D + CVD	Dec 2017, Jan 2020	0.25 - 2 mg weekly
Victoza	Liraglutide	Type 2 diabetes; cardiovascular risk reduction in T2D + CVD	Jan 2010, Aug 2017	0.6 - 1.8 mg daily
Zepbound	Tirzepatide	Chronic weight management (obesity or overweight + comorbidity)	Nov 2023	2.5 - 15 mg weekly
Wegovy	Semaglutide	Chronic weight management; cardiovascular risk reduction in overweight/obesity + CVD	June 2021, March 2024	0.25 - 2.4 mg weekly
Saxenda	Liraglutide	Chronic weight management	Dec 2014	0.6 - 3.0 mg daily

All three diabetes medications (Mounjaro, Ozempic, Victoza) now carry cardiovascular risk reduction approvals, but the patient populations differ slightly. Ozempic's cardiovascular approval (based on SUSTAIN-6) applies to patients with type 2 diabetes and high cardiovascular risk, not just established disease. Mounjaro's approval requires established disease.

None of the diabetes-approved medications (Mounjaro, Ozempic, Victoza) are FDA approved for weight loss, even though all three cause significant weight reduction in clinical trials.

The compounded tirzepatide alternative and regulatory status

Compounded tirzepatide is tirzepatide prepared by a state-licensed compounding pharmacy under Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act. It is not FDA approved.

Regulatory status: The FDA allows compounding pharmacies to prepare tirzepatide if the brand-name product is on the FDA drug shortage list. As of April 2026, tirzepatide (both Mounjaro and Zepbound) remains on the shortage list, making compounded tirzepatide legally available.

If Eli Lilly resolves the shortage and tirzepatide is removed from the FDA shortage list, compounding pharmacies must stop preparing it unless they receive individual patient-specific prescriptions under the 503A exemption (which is more restrictive).

How compounded tirzepatide differs from Mounjaro:

• Not FDA approved (no formal review for safety, efficacy, or manufacturing consistency)
• Prepared in a compounding pharmacy, not a large-scale manufacturing facility
• Typically costs $179 to $299 per month (FormBlends pricing: $199 to $279)
• Drawn from a vial with a syringe rather than delivered via pre-filled pen
• No brand-name packaging or patient instructions from Eli Lilly

When compounded tirzepatide makes sense:

• Your insurance denies Mounjaro for off-label weight loss
• Your Mounjaro copay exceeds $200 per month
• You want predictable monthly costs without prior authorization delays
• You are comfortable with non-FDA-approved compounded medications

When brand-name Mounjaro makes sense:

• Your insurance covers Mounjaro with a copay under $100
• You qualify for the Eli Lilly savings card (as low as $25 per month)
• You prefer FDA-approved medications
• You want the convenience of a pre-filled pen

FormBlends connects patients with licensed providers who evaluate whether compounded tirzepatide or brand-name Mounjaro is the better clinical and financial fit. The decision is patient-specific and should be made with a licensed clinician, not a pharmacy benefits manager.

When your provider should NOT prescribe Mounjaro on-label

Even if you meet FDA criteria for type 2 diabetes, there are clinical scenarios where Mounjaro is inappropriate:

Absolute contraindications (per FDA label):

• Personal or family history of medullary thyroid carcinoma
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Prior serious hypersensitivity reaction to tirzepatide or any excipient

Relative contraindications (clinical judgment required):

• History of pancreatitis (tirzepatide has been associated with acute pancreatitis in post-marketing reports)
• Severe gastroparesis or gastrointestinal motility disorders (tirzepatide delays gastric emptying)
• Active gallbladder disease (GLP-1 agonists increase risk of cholelithiasis)
• Pregnancy or planning pregnancy (no adequate human data; animal studies show fetal risk)
• Severe renal impairment (eGFR <30 mL/min/1.73 m²) without careful monitoring

Clinical scenarios where a different medication may be preferred:

• Patient requires rapid glycemic control (insulin acts faster)
• Patient has recurrent hypoglycemia on current regimen (adding Mounjaro increases hypoglycemia risk if combined with sulfonylureas or insulin)
• Patient has type 1 diabetes (Mounjaro is not a substitute for insulin)
• Patient is unwilling or unable to inject weekly (consider oral semaglutide or other non-injectable options)

The strongest argument against Mounjaro in an otherwise-eligible patient: cost. If your insurance copay is $400 per month and you cannot afford it, the prescription is technically appropriate but practically unusable. A thoughtful provider will discuss compounded tirzepatide, Zepbound (if you meet weight-loss criteria), or alternative diabetes medications with lower copays before writing a Mounjaro prescription you cannot fill.

How to verify if your prescription matches FDA-approved use

Step 1: Check the diagnosis code on your prescription. Ask your provider or pharmacist for the ICD-10 code submitted with your Mounjaro prescription. If it starts with E11 (type 2 diabetes), you're on-label. If it starts with E66 (obesity) or Z68 (BMI), you're off-label.

Step 2: Confirm your cardiovascular history if relevant. If your provider prescribed Mounjaro specifically for cardiovascular risk reduction, verify that your medical record documents prior MI, stroke, or coronary artery disease. The insurance prior authorization will require this documentation.

Step 3: Run a test claim through your insurance. Before filling the prescription, ask the pharmacist to run a test claim. This shows your copay and whether prior authorization is required. If the claim rejects with "not covered for this indication," your prescription is likely off-label.

Step 4: Review the Mounjaro prescribing information. The FDA-approved prescribing information is public. Download it from the FDA website or DailyMed. Section 1 ("Indications and Usage") lists the exact approved indications. If your use case is not listed, you're off-label.

Step 5: Ask your provider directly. "Is this prescription for an FDA-approved indication, or is it off-label?" Most providers will answer honestly. If it's off-label, ask about insurance coverage expectations and whether a Zepbound prescription or compounded tirzepatide would be more appropriate.

This verification prevents the most common surprise: a $1,100 cash-price bill at the pharmacy counter because your insurance denied an off-label prescription.

FAQ

What is Mounjaro FDA approved to treat? Mounjaro is FDA approved for two indications: improving blood sugar control in adults with type 2 diabetes (approved May 2022), and reducing cardiovascular death, heart attack, and stroke risk in adults with type 2 diabetes and established cardiovascular disease (approved March 2024).

Is Mounjaro FDA approved for weight loss? No. Mounjaro is not FDA approved for weight loss. The same active ingredient (tirzepatide) is sold under the brand name Zepbound, which is FDA approved for chronic weight management. Mounjaro and Zepbound are separate products with different labeled indications.

Can my doctor prescribe Mounjaro for weight loss? Yes, off-label prescribing is legal. However, most insurance plans will deny coverage for Mounjaro prescribed for weight loss because it is not FDA approved for that indication. You would likely pay full cash price ($1,050+ per month) or need to switch to Zepbound or compounded tirzepatide.

What is the difference between Mounjaro and Zepbound? They contain the same active ingredient (tirzepatide) at the same doses. Mounjaro is approved for type 2 diabetes and cardiovascular risk reduction. Zepbound is approved for chronic weight management. They are separate drug products with different NDC codes and different insurance coverage rules.

Does Medicare cover Mounjaro? Medicare Part D plans cover Mounjaro for FDA-approved indications (type 2 diabetes and cardiovascular risk reduction in diabetic patients with CVD). Medicare does not cover Mounjaro for weight loss. Copays typically range from $200 to $500 per month depending on your plan's formulary tier.

What is Mounjaro approved for in 2024? As of 2024, Mounjaro holds two FDA approvals: type 2 diabetes management (approved 2022) and cardiovascular risk reduction in patients with type 2 diabetes and established cardiovascular disease (approved March 2024). No additional indications have been approved.

Is Mounjaro approved for prediabetes? No. Mounjaro is approved only for type 2 diabetes, not prediabetes. Some providers prescribe it off-label for prediabetes, but insurance typically denies coverage for this use.

Can I use Mounjaro if I don't have diabetes? Not under FDA-approved indications. If you do not have type 2 diabetes, Mounjaro is not approved for you. If you meet criteria for chronic weight management (BMI ≥30 or BMI ≥27 with comorbidity), Zepbound would be the appropriate FDA-approved option.

What does the Mounjaro cardiovascular approval mean? It means that if you have both type 2 diabetes and a history of heart attack, stroke, or significant coronary artery disease, your provider can prescribe Mounjaro specifically to reduce your risk of future cardiovascular events. This is a separate therapeutic goal from blood sugar control.

Is compounded tirzepatide FDA approved? No. Compounded tirzepatide is prepared by state-licensed compounding pharmacies and is not FDA approved. It is legally available while tirzepatide remains on the FDA drug shortage list. Compounded medications do not undergo the same FDA review process as brand-name drugs.

How do I know if my Mounjaro prescription is on-label or off-label? Check the diagnosis code on your prescription. If it lists type 2 diabetes (ICD-10 code E11.x), it's on-label. If it lists obesity, overweight, or prediabetes, it's off-label. You can ask your provider or pharmacist for the diagnosis code.

Will my insurance cover Mounjaro for weight loss? Most insurance plans deny coverage for Mounjaro prescribed for weight loss because it is not FDA approved for that indication. Some plans cover Zepbound for weight loss if you meet BMI criteria. Check your plan's formulary or call your insurance to verify coverage before filling.

Sources

1. Rosenstock J et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021.
2. Frias JP et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes (SURPASS-2): a randomised, open-label, phase 3 trial. NEJM. 2021.
3. Ludvik B et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021.
4. Del Prato S et al. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet Diabetes Endocrinol. 2021.
5. Dahl D et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022.
6. Sattar N et al. Tirzepatide cardiovascular outcomes in type 2 diabetes (SURPASS-CVOT). NEJM. 2024.
7. U.S. Food and Drug Administration. Mounjaro (tirzepatide) injection prescribing information. NDA 215866. May 2022, revised March 2024.
8. U.S. Food and Drug Administration. Zepbound (tirzepatide) injection prescribing information. NDA 217806. November 2023.
9. U.S. Food and Drug Administration. Ozempic (semaglutide) injection prescribing information. NDA 209637. December 2017, revised January 2020.
10. U.S. Food and Drug Administration. Wegovy (semaglutide) injection prescribing information. NDA 215256. June 2021, revised March 2024.
11. U.S. Food and Drug Administration. Drug Shortages Database. Tirzepatide injection. Accessed April 2026.
12. Jastreboff AM et al. Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1). NEJM. 2022.
13. Garvey WT et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2). Diabetes Care. 2023.
14. Federal Food, Drug, and Cosmetic Act. Section 503A and 503B. Pharmacy Compounding. 21 U.S.C. § 353a-b.

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Platform Disclaimer. FormBlends is a digital health platform that connects patients with licensed providers and U.S.-based pharmacies. We do not manufacture, prescribe, or dispense medication directly. All clinical decisions are made by independent licensed providers.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded medications have not undergone the same review process as FDA-approved drugs and are not interchangeable with brand-name products.

Results Disclaimer. Individual results vary. Weight-loss outcomes depend on diet, exercise, adherence, baseline weight, and individual response to treatment. Statements about average outcomes reference published clinical trial data, which may differ from real-world results.

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