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 sold by some telehealth programs 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 list does not hold still. Between December 2025 and April 2026, the FDA approved two new GLP-1 tablets for chronic weight management: a semaglutide tablet and orforglipron, a small-molecule (non-peptide) GLP-1 receptor agonist.^[3][4] Existing products also gain new uses through label updates, such as the cardiovascular risk indication added after the SELECT trial. A static list on a guide can be out of date the day after the FDA acts.

So we made an editorial choice. Instead of maintaining our own list, we describe the approval history in general terms below and point you to the FDA’s Drugs@FDA database, which the agency updates itself and which links to each product’s current label and approval letters.^[5] That keeps the source of record in one place, and it keeps approved products clearly separate from compounded ones, a distinction the FDA emphasizes in its guidance for telehealth companies on what to know when promoting compounded drugs.

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.

Compounded medications are not FDA-approved: what to check

Some telehealth programs sell compounded GLP-1 medications. Compounded medications are prepared by state-licensed compounding pharmacies (503A) or FDA-registered outsourcing facilities (503B). They are not reviewed or approved by the FDA for safety, effectiveness, or quality. This is the definition of a compounded drug, not a marketing distinction. As of 2026-10-16, FDA’s drug shortage database does not list semaglutide injection or tirzepatide as in shortage, which limits when pharmacies may compound them.

If you are comparing programs, a few questions help you see which kind of product you would be getting. Is the product FDA-approved brand-name or compounded? If compounded, which pharmacy prepares it, and is it a 503A pharmacy or a 503B outsourcing facility? Does the program say clearly that compounded products are not FDA-approved? You can check any product’s approval status yourself on Drugs@FDA. Transformation Health does not accept payment from providers. How we make money.

What the FDA has approved, described in general terms

For context, here is what the FDA approval history looks like, described by active ingredient rather than as a product list. For current product names, labels, and approval letters, Drugs@FDA is the source of record.

• The FDA approved an injectable semaglutide product for type 2 diabetes in 2017, and separately approved a higher-dose injectable semaglutide product for chronic weight management in 2021, for people who meet specific BMI and health criteria.
• In March 2024, injectable semaglutide for weight management also received approval for reducing the risk of major cardiovascular events in certain adults, based on the SELECT trial.^[2] In August 2025, it received accelerated approval for a form of liver disease (MASH with moderate to advanced fibrosis) in adults.^[3]
• An oral semaglutide tablet has been approved for type 2 diabetes since 2019. In December 2025, the FDA approved a semaglutide tablet for chronic weight management and cardiovascular risk reduction in certain adults.^[3]
• The FDA approved an injectable tirzepatide product for type 2 diabetes in 2022, and separately approved one for chronic weight management in 2023. In December 2024, a tirzepatide product became the first medication approved for moderate-to-severe obstructive sleep apnea in adults with obesity, based on the SURMOUNT-OSA trial.
• In April 2026, the FDA approved orforglipron, a once-daily GLP-1 receptor agonist tablet, for chronic weight management in adults with obesity, or with overweight and at least one weight-related condition.^[4]
• Older GLP-1 receptor agonists, including liraglutide (approved for both type 2 diabetes and chronic weight management) and others approved for diabetes, came earlier.

Each of these is a distinct product the FDA has approved for a specific use. These medications also carry risks. The most common side effects are gastrointestinal (nausea, diarrhea, vomiting, constipation), and the labels for these products carry a boxed warning about thyroid C-cell tumors. See GLP-1 side effects and each product’s FDA label for the full safety information.

Compounded medications can be tailored to the individual

Under 503A rules, a compounded formulation is prepared for an individual patient’s prescription rather than mass-produced. Because of that, a prescriber can request a formulation that includes more than the GLP-1 ingredient alone.

Some compounded formulations sold by programs add other ingredients, such as vitamin B12. These combinations have not been studied in the clinical trials of the FDA-approved products, and the FDA has not reviewed them. Whether any of this is appropriate for you is a clinical decision made by the licensed provider you choose, 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

When you compare programs, check which of these two categories the product falls into, and compare the total cost: medication, dose increases, visits, labs, shipping, membership fees, and cancellation terms. At most telehealth programs, a licensed provider reviews your health history and decides whether a prescription is appropriate, and which product fits. Prices vary by program and dose.

Key takeaways

• We made an editorial decision not to maintain our own list of FDA-approved GLP-1 medications, because approvals and indications change often. Drugs@FDA is the source of record.
• 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.
• Compounded GLP-1 medications sold by some programs are, by definition, 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 any GLP-1 medication is appropriate for you is a decision made by a 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/

[3] FDA. WEGOVY (semaglutide) injection and tablets prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s007lbl.pdf

[4] FDA. FOUNDAYO (orforglipron) tablets prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934Orig1s000lbl.pdf

[5] FDA. Drugs@FDA: FDA-Approved Drugs (database). https://www.accessdata.fda.gov/scripts/cder/daf/