Quick answer: FDA has approved a number of peptide drugs, each as a specific brand product with its own label, listed in the first table below with label dates read on 2026-10-07. FDA has approved no product containing BPC-157, CJC-1295, ipamorelin, TB-500 or retatrutide. Sermorelin's brand drug was discontinued, and FDA's approval of it was withdrawn effective 2009-06-18. Compounded medications are not FDA-approved.
An approved drug is a particular product, with a label that says what it is approved for and what risks it carries. This page lists the approved peptide drugs we could confirm, then the popular peptides that have no approved product, with the dated FDA statements behind each. Some links elsewhere on this site are affiliate links; there are none on this page.
Approved peptide drugs: a dated table
The table lists products whose current labels we read in DailyMed on 2026-10-07. Original approval dates come from openFDA's Drugs@FDA data. Indication wording is quoted from each label in the final column, abbreviated, because it uses medical terms we do not use ourselves. We did not check each drug's chain length against FDA's 40-amino-acid line, and the table is not a complete list of every approved peptide.
| Brand (active ingredient) | Original approval | Label effective date | Indication, as the label words it |
|---|---|---|---|
| Wegovy (semaglutide) | 2021-06-04 | 2026-06-18 | with a reduced calorie diet and increased physical activity, reduce risk of major adverse cardiovascular events in adults with established cardiovascular disease and obesity or overweight; reduce excess body weight and maintain weight reduction in adults and pediatric patients 12 and older with obesity; further indications are listed on the label |
| Ozempic (semaglutide) | 2017-12-05 | 2026-06-01 | adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes; reduce risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; further indications are listed on the label |
| Rybelsus (oral semaglutide) | 2019-09-20 | 2026-01-30 | adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes; cardiovascular indication also listed |
| Zepbound (tirzepatide) | 2023-11-08 | 2026-08-28 | with a reduced-calorie diet and increased physical activity, reduce excess body weight and maintain weight reduction in adults with obesity or overweight plus a comorbidity; treat moderate to severe obstructive sleep apnea in adults with obesity |
| Mounjaro (tirzepatide) | 2022-05-13 | 2026-08-27 | adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 and older with type 2 diabetes; cardiovascular indication also listed |
| Saxenda (liraglutide) | 2014-12-23 | 2026-02-25 | with reduced calorie diet and increased physical activity, reduce excess body weight and maintain weight reduction in adults and pediatric patients 12 and older with obesity, and adults with overweight plus a comorbidity |
| Victoza (liraglutide) | 2010-01-25 | 2025-10-14 | adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 and older with type 2 diabetes; cardiovascular indication also listed |
| Egrifta WR (tesamorelin) | 2010-11-10 (as Egrifta) | 2026-07-29 | reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy; the label also says it is not indicated for weight loss management |
| Forteo (teriparatide) | 2002-11-26 | 2026-08-03 | treatment of postmenopausal women with osteoporosis at high risk for fracture; further indications are listed on the label |
| Sandostatin injection (octreotide) | 1988-10-21 | 2026-07-22 | acromegaly; symptomatic treatment of metastatic carcinoid tumors; VIPomas |
| Vyleesi (bremelanotide) | 2019-06-21 | 2025-11-13 | premenopausal women with acquired, generalized hypoactive sexual desire disorder meeting the label's criteria; the label says it is not indicated to enhance sexual performance |
| Imcivree (setmelanotide) | 2020-11-25 | 2026-04-01 | reduce excess body weight and maintain reduction in adults and pediatric patients with acquired hypothalamic obesity and with syndromic or monogenic obesity due to BBS, POMC/PCSK1 or LEPR deficiency |
As of 2026-10-07. Sources: DailyMed labels (SPL XML) for the set IDs in the sources list; openFDA Drugs@FDA application data. Rybelsus date: openFDA also lists a second original-application entry dated 2020-01-16 whose meaning we did not establish. Egrifta SV, a second Egrifta label, was not read.
A few reading notes. The semaglutide, tirzepatide and liraglutide brands carry a boxed warning titled "RISK OF THYROID C-CELL TUMORS," according to their labels. Egrifta WR, Forteo, Sandostatin, Vyleesi and Imcivree labels showed no boxed-warning section in the label data we read. The Wegovy label also covers a tablet form; we state nothing about the tablet's own indication. Peptide side effects covers what the labels list.
An approval belongs to the product and its stated uses. Seeing semaglutide or tirzepatide in this table does not make a compounded version approved. Compounded medications are not FDA-approved, and the difference is explained in compounded peptides.
Sermorelin: approved once, withdrawn, and still discussed
Sermorelin is the case people ask about most, because it was approved and then was not. The Federal Register notice of 2013-03-04 (78 FR 14095) gives the record. The ampule product (NDA 19-863) was initially approved on 1990-12-28. The vial product (NDA 20-443) was initially approved on 1997-09-26. Both were held by EMD Serono. The notice says the vial was indicated for idiopathic growth hormone deficiency in children with growth failure.
Its maker's letters in 2008 said it was being discontinued. FDA announced in the Federal Register on 2009-05-19 that it was withdrawing approval of both applications, effective 2009-06-18. In 2013, after a citizen petition, FDA determined the Geref products "were not withdrawn from sale for reasons of safety or effectiveness." The notice does not give the maker's reason for discontinuing, so we do not offer one.
Today openFDA lists both Geref applications as "Discontinued," and we found no current DailyMed label for Geref. So sermorelin has no FDA-approved product on the market. FDA's 503B category document (updated 2025-03-21) lists sermorelin acetate in Category 1 with a mark for components of FDA-approved drugs, and the 503A document (updated 2026-05-14) does not list it. See buy sermorelin online for the route detail.
Popular peptides with no FDA-approved product
The second table covers peptides that come up often in searches. "No FDA-approved product" means we found none in Drugs@FDA or DailyMed on 2026-10-07 and none in FDA's documents named below.
| Peptide | FDA-approved product? | What FDA's documents say | Source and date |
|---|---|---|---|
| BPC-157 | None found | FDA staff briefing says it is not a component of an FDA-approved drug and is marketed in the US as an ingredient in dietary supplement products. FDA's safety-risks page lists it as previously in Category 2 and withdrawn by the nominators, and still prints a safety concern. Staff wrote that the evaluation criteria "weigh against" the 503A bulks list; the advisory committee met over two days in July 2026, and FDA has published no outcome that we could find on 2026-10-07 | FDA briefing memo dated 2026-05-11; safety-risks page current as of 2026-04-22 |
| CJC-1295 | None found | Listed on the same page as previously in Category 2 and withdrawn by the nominators. The same entry mentions reported serious events such as a raised heart rate and a vasodilatory reaction, and describes the clinical data as limited. Not listed in the 503A or 503B category documents | Safety-risks page current as of 2026-04-22 |
| Ipamorelin | None found | An active Category 2 entry for outsourcing facilities (503B), added 2023-09-29, with an immunogenicity risk; also repeated in the withdrawn table. Not in the 503A document | Safety-risks page current as of 2026-04-22; 503B document updated 2025-03-21 |
| TB-500 | None found | Listed as previously in Category 2 and withdrawn. FDA says it has not identified any human exposure data for the drug products. FDA's staff briefing proposed not adding it to the 503A bulks list | Safety-risks page current as of 2026-04-22; FDA briefing memo dated 2026-05-15 |
| Retatrutide | None found | FDA says retatrutide cannot be used in compounding under federal law and has not been found safe and effective for any condition. Not on the category lists | FDA GLP-1 page current as of 2026-10-01 |
| Sermorelin | None marketed. Brand drug discontinued; approval withdrawn effective 2009-06-18 | See the section above | Federal Register 2013-03-04; openFDA |
As of 2026-10-07. Sources are the pages named in each row; see the sources list below.
FDA's ruling language needs care. Its safety-risks page puts BPC-157 and CJC-1295 in a table titled for substances "nominated but withdrawn," and introduces it as a list of substances previously in Category 2 that were withdrawn by the nominators. We do not describe either as currently in Category 2, and we do not describe either as banned. What the page shows is that FDA still prints safety concerns for them. FDA has not told us that a pharmacy may compound BPC-157 or CJC-1295, either: we found no FDA sentence on the legal effect for a 503A pharmacy.
How to check any peptide's status yourself
These steps use free federal databases.
- Search Drugs@FDA. Enter the brand name or active ingredient. A result with an application number and an approval date means FDA has approved that product. No result means no approved product under that name.
- Open the label on DailyMed. The label shows the current indications, boxed warnings and effective date. Confirm that the label's maker matches the product you are being offered.
- Check FDA's compounding category pages. If a pharmacy compounds the ingredient, look for it on FDA's 503A and 503B category documents and its safety-risks page, and note the date at the top of each.
- Search FDA's drug alert and warning-letter pages. FDA publishes notices on unapproved products, including GLP-1 drugs.
- Ask the seller in writing. Ask for the product's FDA status in plain words. If the answer is "research use" or "not for human consumption," FDA's warning letters say that wording does not change what the product is meant for. See research peptides explained.
The same logic scales to the legal questions in is it legal to buy peptides online, and the five-point seller test is in how to choose a peptide company.
What approval does and does not mean
Approval means FDA reviewed an application for a specific product and its labeled uses. For a peptide with no approved product, FDA's briefings describe limited or missing safety information for several of them. That is a reason to ask who made the product, what it contains and why an approved option is not the one offered.
Sources
- DailyMed: Wegovy label effective 2026-06-18, read 2026-10-07
- DailyMed: Ozempic label effective 2026-06-01, read 2026-10-07
- DailyMed: Rybelsus label effective 2026-01-30, read 2026-10-07
- DailyMed: Zepbound label effective 2026-08-28, read 2026-10-07
- DailyMed: Mounjaro label effective 2026-08-27, read 2026-10-07
- DailyMed: Saxenda label effective 2026-02-25, read 2026-10-07
- DailyMed: Victoza label effective 2025-10-14, read 2026-10-07
- DailyMed: Egrifta WR label effective 2026-07-29, read 2026-10-07
- DailyMed: Forteo label effective 2026-08-03, read 2026-10-07
- DailyMed: Sandostatin label effective 2026-07-22, read 2026-10-07
- DailyMed: Vyleesi label effective 2025-11-13, read 2026-10-07
- DailyMed: Imcivree label effective 2026-04-01, read 2026-10-07
- openFDA: Drugs@FDA application data read 2026-10-07
- Federal Register: Determination that Geref (sermorelin acetate) was not withdrawn for safety or effectiveness, 2013-03-04 read 2026-10-07
- FDA: Certain bulk drug substances that may present significant safety risks page current as of 2026-04-22, read 2026-10-07
- FDA: 503A bulk drug substances category document updated 2026-05-14, read 2026-10-07
- FDA: 503B bulk drug substances category document updated 2025-03-21, read 2026-10-07
- FDA: BPC-157 briefing document memo dated 2026-05-11, read 2026-10-07
- FDA: TB-500 briefing document memo dated 2026-05-15, read 2026-10-07
- FDA: Pharmacy Compounding Advisory Committee meeting, 2026-07-23 and 2026-07-24 page current as of 2026-08-06, read 2026-10-07
- FDA: Concerns with unapproved GLP-1 drugs used for weight loss page current as of 2026-10-01, read 2026-10-07
FAQ
Which peptides are FDA-approved?
Several, each as a named product. The table above covers the semaglutide, tirzepatide and liraglutide brands, Egrifta WR (tesamorelin), Forteo, Sandostatin, Vyleesi and Imcivree, with label dates read on 2026-10-07. It is not a complete list of every approved peptide.
Is BPC-157 FDA-approved?
No. FDA's staff briefing, dated 2026-05-11, says BPC-157 is not a component of an FDA-approved drug. We found no approved BPC-157 product.
Is sermorelin FDA-approved?
Not today. The Geref brand was approved in 1990 and 1997. FDA's approval of it was withdrawn effective 2009-06-18, after its maker discontinued it, and FDA found in 2013 that it was not withdrawn for reasons of safety or effectiveness.
Are CJC-1295 and ipamorelin approved?
No product containing either is FDA-approved. Ipamorelin acetate has an active Category 2 entry for 503B outsourcing facilities. CJC-1295 appears among substances withdrawn by the nominators from Category 2, and FDA still prints safety concerns for it.
Is a compounded version of an approved peptide approved?
No. Compounded medications are not FDA-approved. A product can contain the same ingredient as an approved drug without being approved itself.
How do I check whether a peptide is approved?
Search Drugs@FDA for an application and approval date, open the label on DailyMed, then check FDA's compounding category pages. Write down the page dates when you do.
Not medical advice. See the medical disclaimer.
