FDA-Approved GLP-1 Medications: Why We Don't Publish a List

If you searched for a list of FDA-approved GLP-1 medications, you were probably trying to sort out a few honest questions. Which medications has the FDA actually approved? What does approval mean? And how do the compounded medications offered by telehealth companies, including the ones we offer, fit into that picture?

We will answer those questions. But first, an honest note about what this page does and does not do.

An editorial decision: why we no longer publish a medication list

This page was originally a reference list of FDA-approved GLP-1 and GLP-1/GIP medications, organized by brand name and indication. We have removed that list on purpose.

The FDA has published guidance for telehealth companies on what to know when promoting compounded drugs. A central concern in that guidance, and in the warning letters the FDA has sent to telehealth companies, is marketing that implies a compounded medication is the same as an FDA-approved branded product. Placing a list of FDA-approved brand names next to our own compounded offerings risks creating exactly that impression, even when it is not intended.

So we made an editorial choice. We do not publish the brand names of FDA-approved GLP-1 medications on this page, because we do not want anything we write to blur the line between those products and the compounded medications we provide. The two are not the same, and the clearest way to say so is to keep them clearly separate.

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 for the indication the FDA approved, unless a provider prescribes it off-label

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

Compounded medications follow a different legal path entirely. They are prepared by state-licensed pharmacies under 503A/503B compounding law. They are not reviewed by the FDA for safety, efficacy, or quality. That legal framework is separate from FDA approval, which is the heart of the distinction below.

The medications we offer are compounded. By definition, they are not FDA-approved.

Every GLP-1 medication currently available through Transformation Health is a compounded medication. Compounded medications are prepared by US-based, state-licensed compounding pharmacies for an individual patient. They are not reviewed or approved by the FDA for safety, effectiveness, or quality.

This is not a technicality or a marketing distinction. It is the definition of a compounded drug. We state it plainly because the FDA has been clear that telehealth companies should not imply otherwise, and because you deserve to make this decision with accurate information.

What the FDA has approved, described in general terms

For context, here is what the FDA approval history looks like, described in general terms and without brand names. We have intentionally left the brand names out, because naming them is what creates the risk of implying our compounded medications are equivalent to them.

• The FDA approved a branded injectable formulation containing semaglutide for type 2 diabetes, and separately approved a higher-dose branded formulation containing semaglutide for chronic weight management in adults who meet specific BMI and health criteria.
• Branded formulations containing semaglutide later received approval for reducing cardiovascular risk in certain adults, based on the SELECT trial.^[2]
• A branded oral formulation containing semaglutide is approved for type 2 diabetes.
• The FDA approved a branded injectable formulation containing tirzepatide for type 2 diabetes, and separately for chronic weight management. In December 2024, a tirzepatide formulation became the first medication approved for moderate-to-severe obstructive sleep apnea in adults with obesity, based on the SURMOUNT-OSA trial.
• Older GLP-1 receptor agonists, including liraglutide (approved for both type 2 diabetes and chronic weight management) and others approved for diabetes, came earlier and are less commonly used today.

Each of these is a distinct product the FDA has approved for a specific use. If you want the specific branded products and their labeling, the FDA’s own resources are the most reliable place to find them.

Compounded medications can be tailored to the individual

One practical feature of compounded preparation is that a formulation is made for an individual patient rather than mass-produced. Because of that, a provider can request a formulation that includes more than the GLP-1 ingredient alone.

Some compounded formulations add other ingredients. Vitamin B12, for example, is sometimes included for patients who report low energy, and some formulations include ingredients intended to help manage common GLP-1 side effects such as nausea. Whether any of this is appropriate for you is a clinical decision made by your independent provider, based on your health history.

One point needs to stay clear: a compounded formulation that includes additional ingredients is still a compounded medication, and it is still not FDA-approved.

Compounded GLP-1 medications used by more than 2 million

Compounded GLP-1 medications became widely used during the period when the FDA listed semaglutide and tirzepatide as drugs in shortage. One published estimate, in the Journal of Comparative Effectiveness Research, reported that as of October 2024 more than 2 million Americans had received treatment with compounded versions of GLP-1 drugs.^[1]

That figure reflects how common these medications became during the shortage period. It is not an endorsement of their safety or effectiveness, which the FDA has not evaluated.

Compounded vs. branded: the distinction in plain terms

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
• 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 and have not undergone FDA review for safety, efficacy, or quality
• Are prepared under a different legal framework (state pharmacy law and 503A/503B compounding provisions)
• May vary in formulation, purity, and potency
• Have not completed the clinical trials required for FDA approval
• Do not have FDA-approved labeling

Transformation Health programs use compounded medications prepared by US-based, licensed compounding pharmacies. These are not FDA-approved products, and they are not the same as branded medications. Our pricing is all-inclusive: your monthly fee covers your medication, lab work (Quest or Labcorp), and medical weight loss coaching, with no hidden fees. An independent, licensed provider reviews your health history and determines whether a compounded GLP-1 medication is appropriate for you.

Key takeaways

• We made an editorial decision not to publish a list of FDA-approved GLP-1 brand names, so that nothing on this page implies our compounded medications are equivalent to products the FDA has approved.
• 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 use.
• The GLP-1 medications offered through Transformation Health are compounded. By definition, they are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness, or quality.
• Compounded medications can be tailored for an individual, including formulations with added ingredients such as B12. A tailored formulation is still compounded and still not FDA-approved.
• Whether compounded GLP-1 is appropriate for you is a decision made by an independent, licensed provider who evaluates your health history and goals.

Citations

[1] Pearson SD, Whaley CM, Emond SK. “Affordable access to GLP-1 obesity medications: strategies to guide market action and policy solutions in the US.” Journal of Comparative Effectiveness Research 2025;14(9):e250083. https://pubmed.ncbi.nlm.nih.gov/40641455/

[2] Lincoff AM et al. “Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.” New England Journal of Medicine 2023;389(24):2221-2232. https://pubmed.ncbi.nlm.nih.gov/37952131/