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FDA-Approved GLP-1 Medications: Complete Reference List

Transformation Health Medical Team April 21, 2026 7 min read

If you are researching GLP-1 medications, you have probably encountered brand names, generic terms, and confusing distinctions. Is semaglutide the same thing as the brand-name product you have heard of? What does it mean if something is FDA-approved? And what is the difference between FDA-approved drugs and compounded medications?

This page is a reference guide to every FDA-approved GLP-1 and GLP-1/GIP receptor agonist medication currently available. It exists to help you understand what FDA approval means, how these medications differ from one another, and how they differ from compounded versions.

What FDA Approval Actually Means

FDA approval is more specific than many people realize. When the FDA approves a medication, the agency is approving it for a specific indication, not approving the ingredient in general.

FDA approval means:

  • The manufacturer submitted clinical trial data, safety reports, manufacturing standards, and labeling to the FDA
  • FDA reviewers evaluated whether the evidence supports that the medication is safe and effective for that specific indication
  • The drug can only be legally marketed and prescribed for the indication the FDA approved, unless a provider prescribes it off-label

This is critical: a drug approved for type 2 diabetes is not automatically approved for weight management. The FDA reviews these as separate indications with separate evidence.

Compounded medications follow a different legal path. Compounded GLP-1s are prepared by state-licensed pharmacies under 503A/503B compounding law. They are not reviewed by the FDA for safety, efficacy, or quality. They exist because the FDA has designated semaglutide and tirzepatide as drugs in shortage, which allows compounding pharmacies to prepare them. This legal framework is completely separate from FDA approval.

Semaglutide: FDA-Approved Medications

There are three different FDA-approved semaglutide products. All contain semaglutide as the active ingredient, but they are three separate medications with different approved uses and dose ranges.

Semaglutide for type 2 diabetes, injectable, 0.5mg, 1mg, 2mg

FDA approval: Type 2 diabetes. Injectable, once weekly.

Maximum dose: 2mg per week.

Cardiovascular indication: This semaglutide product also carries approval for cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease (approved 2024, based on SELECT trial data).[1]

Who this is for: Adults with type 2 diabetes as an adjunct to diet and exercise. Also indicated for reducing cardiovascular death, heart attack, and stroke in adults with type 2 diabetes and established CVD.

This formulation is not FDA-approved for weight management in people without type 2 diabetes, though providers may prescribe it off-label for weight loss in some cases.

Semaglutide for chronic weight management, injectable, 2.4mg

FDA approval: Chronic weight management.

Indication details: FDA-approved for adults with BMI 30 or higher, or BMI 27 or higher with at least one weight-related condition (such as hypertension, type 2 diabetes, dyslipidemia, sleep apnea, or cardiovascular disease).

Maximum dose: 2.4mg per week. This is higher than the diabetes-indicated semaglutide maximum of 2mg.

Cardiovascular indication: This product also carries approval for cardiovascular risk reduction in adults with obesity or overweight and established cardiovascular disease (approved 2024).[2]

Who this is for: Adults seeking GLP-1 medication specifically for weight management who meet BMI or health condition criteria. This is the branded semaglutide product explicitly approved for that indication.

Oral semaglutide for type 2 diabetes, 3mg, 7mg, 14mg

FDA approval: Type 2 diabetes only.

Route: Oral tablets, taken once daily.

Weight management approval: This oral formulation is NOT FDA-approved for weight management.

Who this is for: Adults with type 2 diabetes who prefer or need an oral formulation rather than an injectable.

Absorption depends on taking the tablet on an empty stomach with a small glass of water, which makes adherence more complex than weekly injections.

Tirzepatide: FDA-Approved Medications

There are two FDA-approved tirzepatide products. Like semaglutide, both contain the same active ingredient but are approved for different indications.

Tirzepatide for type 2 diabetes, injectable, 2.5mg-15mg

FDA approval: Type 2 diabetes.

Route: Injectable, once weekly. Comes in dose strengths from 2.5mg to 15mg.

Who this is for: Adults with type 2 diabetes as an adjunct to diet and exercise.

This formulation is not FDA-approved for weight management, though some providers prescribe it off-label for weight loss.

Tirzepatide for chronic weight management, injectable, 2.5mg-15mg

FDA approval: Chronic weight management.

Indication details: FDA-approved for adults with BMI 30 or higher, or BMI 27 or higher with at least one weight-related condition.

Route: Injectable, once weekly.

Obstructive sleep apnea indication: This product received FDA approval in December 2024 for treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. This makes it the first GLP-1/GIP medication approved for sleep apnea as a primary indication.[3]

Who this is for: Adults seeking GLP-1/GIP medication for weight management who meet BMI criteria, or adults with moderate-to-severe OSA and obesity.

Other FDA-Approved GLP-1 Medications

These are older GLP-1 receptor agonists. They are less commonly prescribed than semaglutide and tirzepatide, and they are not typically used for compounding.

Liraglutide

Type 2 diabetes: FDA-approved for type 2 diabetes. Daily injection.

Weight management: FDA-approved for chronic weight management. Daily injection.

Status: Liraglutide was the first GLP-1 approved for weight management (2014). It is older than semaglutide and tirzepatide and requires daily injections rather than weekly ones, which affects adherence. It is rarely compounded.

Dulaglutide

FDA approval: Type 2 diabetes only.

Route: Weekly injection.

Weight management approval: Dulaglutide is not a primary weight management medication, though some off-label prescribing occurs.

Status: Older GLP-1. Less commonly prescribed.

Exenatide (Byetta, Bydureon)

FDA approval: Type 2 diabetes.

Status: One of the original GLP-1 receptor agonists (approved 2005). Byetta requires twice-daily injections; Bydureon is weekly. Both are older and less commonly used than modern GLP-1s.

Albiglutide (Tanzeum)

Status: Discontinued. This medication is no longer manufactured or available.

FDA Indications Explained

FDA approval for GLP-1 medications falls into three main categories (sometimes overlapping):

Type 2 Diabetes Indication

Branded semaglutide (diabetes-indicated), branded tirzepatide (diabetes-indicated), liraglutide (diabetes-indicated), dulaglutide, and exenatide products are all approved for type 2 diabetes. This indication means the medication has been shown to help lower blood sugar in adults with type 2 diabetes when used alongside diet and exercise. Type 2 diabetes is the indication for which GLP-1s were originally developed.

Chronic Weight Management Indication

Branded semaglutide (weight-management-indicated), branded tirzepatide (weight-management-indicated), and liraglutide (weight-management-indicated) are FDA-approved specifically for chronic weight management. This indication means the medication has been shown to help adults with obesity or overweight lose weight and sustain that loss when used alongside diet and exercise, according to FDA-reviewed clinical trial data.

The criteria for eligibility are: BMI of 30 or higher, or BMI of 27 or higher with at least one weight-related condition.

Cardiovascular Risk Reduction Indication

As of 2024, both branded semaglutide products (the diabetes-indicated and weight-management-indicated formulations) carry a separate FDA approval for cardiovascular risk reduction in adults with established cardiovascular disease and obesity or overweight. This is based on the SELECT trial, which showed that semaglutide reduced the risk of cardiovascular death, heart attack, and stroke in this population.[4]

Tirzepatide does not yet have this indication, though similar trials are underway.

Obstructive Sleep Apnea Indication

The weight-management-indicated tirzepatide product received a unique FDA approval in December 2024 for treatment of moderate-to-severe obstructive sleep apnea in adults with obesity. This approval was based on the SURMOUNT-OSA trial, which showed that tirzepatide reduced sleep apnea severity. This is the first GLP-1/GIP medication approved for sleep apnea as a primary indication.[5]

Compounded vs. FDA-Approved: The Key Distinction

You will encounter the term “compounded GLP-1” frequently. Understanding how it differs from FDA-approved versions is essential.

FDA-approved branded semaglutide and tirzepatide products:

  • Are manufactured by the drug company using controlled processes
  • Have been reviewed by the FDA for safety, efficacy, and manufacturing quality
  • Have completed clinical trials demonstrating efficacy for their approved indication
  • Have a standardized formulation, purity, and potency
  • Are regulated throughout their shelf life
  • Carry FDA-approved labeling with detailed safety and efficacy information

Compounded GLP-1 medications containing semaglutide or tirzepatide:

  • Are prepared by state-licensed compounding pharmacies, not by pharmaceutical manufacturers
  • Are not FDA-approved products and have not undergone FDA review for safety, efficacy, or quality
  • Are prepared under a different legal framework (the drug shortage list and 503A/503B compounding law)
  • May vary in formulation, purity, and potency from batch to batch
  • Have not completed the clinical trials required for FDA approval
  • Do not have FDA-approved labeling

Compounded GLP-1 medications exist because the FDA has designated semaglutide and tirzepatide as drugs in shortage. This allows compounding pharmacies to prepare them for patients when the branded versions are unavailable or unaffordable.[6] However, this legal permission does not make them FDA-approved, and they carry different risks and uncertainties than brand-name products.

Transformation Health programs use compounded versions prepared by US-based, licensed compounding pharmacies. These are not the same as FDA-approved branded medications. Your independent provider will review your health history and determine whether compounded GLP-1 is appropriate for your situation.

Key Takeaways

  • FDA approval is indication-specific. A drug approved for type 2 diabetes is not approved for weight management unless the FDA separately approves it for that indication.
  • Semaglutide and tirzepatide each have two separate FDA-approved products: one for diabetes, one for weight management. They are not interchangeable.
  • Branded oral semaglutide is only approved for diabetes, not weight management.
  • Branded tirzepatide is the only GLP-1/GIP medication FDA-approved for sleep apnea.
  • Compounded GLP-1 medications are not FDA-approved. They are prepared by state-licensed pharmacies under different legal rules. They differ from branded versions in formulation, purity, and regulation.
  • Whether you pursue branded or compounded GLP-1, the clinical decision is made by an independent, licensed provider who evaluates whether the medication is appropriate for your health history and goals.

Important: Compounded medications are not FDA-approved products. They are prepared by US-based, state-licensed compounding pharmacies and have not been independently evaluated by the FDA for safety, efficacy, or quality. Brand-name semaglutide and tirzepatide products are registered trademarks of their respective manufacturers. Transformation Health is not affiliated with or endorsed by any manufacturer of branded GLP-1 medications. All prescriptions require evaluation by an independent, licensed healthcare provider. Not all patients will qualify. Results vary by individual.

Citations

[1] Lincoff AM et al. “Semaglutide and cardiovascular outcomes in obesity without diabetes.” New England Journal of Medicine 2023;389(22):2029-2041. https://pubmed.ncbi.nlm.nih.gov/37952131/

[2] FDA. “FDA Approves New Medication for Chronic Weight Management.” FDA News. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf

[3] FDA. “FDA Approves New Medication for Chronic Weight Management and to Improve Cardiovascular Outcomes for Overweight and Obese Patients.” FDA Press Release, December 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf

[4] Lincoff AM et al. “Semaglutide and cardiovascular outcomes in obesity without diabetes.” New England Journal of Medicine 2023;389(22):2029-2041. https://pubmed.ncbi.nlm.nih.gov/37952131/

[5] FDA. “Prescribing Information for tirzepatide for chronic weight management and obstructive sleep apnea.” December 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf

[6] FDA. “Medications in Shortage.” U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-shortages

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What is the difference between branded semaglutide for diabetes and branded semaglutide for weight management?
Both contain semaglutide, but they are FDA-approved for different indications. The diabetes-indicated product is approved for type 2 diabetes at a maximum 2mg weekly dose. The weight-management-indicated product is approved for chronic weight management at a higher 2.4mg weekly maximum. They are different FDA-approved branded products, though the active ingredient is the same.
Is tirzepatide approved for weight loss?
Yes. Tirzepatide is FDA-approved as a branded product for chronic weight management in adults with BMI 30 or higher, or BMI 27 or higher with at least one weight-related condition. A separate branded tirzepatide product is FDA-approved for type 2 diabetes only.
Is compounded GLP-1 the same as these FDA-approved medications?
No. Compounded GLP-1 medications contain semaglutide or tirzepatide as the active pharmaceutical ingredient, but they are not FDA-approved products. They are prepared by licensed compounding pharmacies under state pharmacy law and specific federal provisions, and have not been independently reviewed by the FDA for safety, efficacy, or quality. This is a meaningful distinction.
Are there GLP-1 medications approved specifically for sleep apnea?
Yes. Tirzepatide (under its branded weight-management product) received FDA approval in December 2024 for treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. It is the first medication approved specifically for this indication. This is separate from its weight management approval.

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Medical Disclaimer: All medical services are provided by independent, U.S.-licensed healthcare providers. Compounded medications are not FDA-approved. Results vary by individual and are not guaranteed. Our providers only prescribe when clinically appropriate. For residents of AR, DC, DE, MS, NM, RI, and WV, state regulations require an initial live video consultation before a prescription can be written.

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Transformation Health is a modern technology platform designed to connect you with high-quality, convenient telehealth services. We facilitate your access to medical care; we do not provide the medical care ourselves.

All medical services are provided by independent, U.S.-licensed healthcare providers. These dedicated professionals are responsible for all clinical decisions, including diagnosis, treatment, and prescribing. Your confidential doctor-patient relationship is established directly with your independent provider to ensure your care is compliant, personalized, and focused on your unique health goals.

Understanding Your Medication: Compounded Formulations

The medications available through this platform are prepared by U.S.-based, state-licensed compounding pharmacies. These facilities are highly regulated and must adhere to standards set by their respective State Boards of Pharmacy.

Compounding allows pharmacists to create personalized medication formulations to meet specific patient needs, such as providing an alternative for a medication that is in shortage or creating a formulation without an ingredient a patient is allergic to.

It is important to understand that, as is the case with all compounded medications, these specific formulations are not FDA-approved. The FDA-approval process is designed for mass-produced, branded drugs. Compounded medications (which may utilize salt forms like semaglutide sodium/acetate) are prepared for individual patients and do not undergo the same large-scale FDA review for safety and efficacy. Your licensed provider will determine if this type of medication is the appropriate treatment for you. Transformation Health is not affiliated with, nor endorsed by, the manufacturers of any brand-name medications mentioned (e.g., Ozempic®, Wegovy®, Mounjaro®).

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We are passionate about providing helpful, informative content on our website. Please note that this information is intended for educational purposes only and does not constitute professional medical advice, diagnosis, or treatment. Your health journey is unique, so we encourage you to always consult your personal physician or another qualified health provider with any questions about a medical condition or before starting any new treatment program.

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It's important to understand that results are not guaranteed and will vary from person to person. Your personal success depends on a wide range of factors, including your starting point, your adherence to the program, lifestyle habits, and your unique medical history.

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You may see references to brand-name medications like Wegovy®, Ozempic®, Mounjaro®, and Zepbound®. These are registered trademarks of their respective owners (Novo Nordisk A/S and Eli Lilly and Company) and are FDA-approved medications. The compounded medications available through this platform are not affiliated with or endorsed by the owners of these trademarks. They are alternative formulations prescribed by your provider to meet your specific clinical needs.