What Peptides Are FDA Approved? The Complete 2026 List

Last updated: September 30, 2026

Search for a list of FDA-approved peptides and the first page of results will tell you 14, then 34, then more than 80. All three numbers sit on sites that look authoritative. Most of those lists also mix approved prescription drugs with compounds sold in vials online, so the count falls apart before you finish reading it.

This page sets out to do three things. It lists every FDA-approved peptide drug, grouped by what the drug treats, with the year of first approval. A second section gives a plain verdict on the popular peptides that are not approved. The last one names compounds sitting in late-stage trials, because future approvals will come from there.

Approval is a narrow thing, and the narrowness is the whole point. When the FDA approves a peptide, it has reviewed safety and efficacy data for one product, from one manufacturer, for one labeled use. A chemical carrying the same name and sold for laboratory research has been through none of that. Two vials can hold the same molecule on paper and sit in completely different regulatory worlds. Hold on to that distinction and the rest of this page reads easily.

The short answer

As of September 2026, this page lists 47 FDA-approved peptide drugs, the earliest approved in 1960. The FDA publishes no official total, and the peer-reviewed counts in circulation each cover a different window. That number comes from a peer-reviewed harvest of FDA approvals published in 2026, not from the agency, because the FDA publishes no official total.

None of the peptides sold as research chemicals appear on that list. BPC-157, TB-500, KPV, GHK-Cu, ipamorelin, CJC-1295 and Semax are all unapproved as of September 2026.

Three investigational drugs sit near the line without crossing it. Retatrutide, CagriSema and survodutide are in phase 3 trials, and none of them is approved.

Full tables follow, grouped by therapeutic area. To check any single compound yourself, skip to the verification section near the end, which names the FDA databases that give a straight answer.

Why you'll see three different numbers (14, 34, 80)

The three figures are not competing claims about the same thing. Each one counts something different, and only one of them carries a source you can check.

Take the figure 14 first, which several competitor pages print as though the FDA published it. No agency document backs that number. It is a curated selection, usually the drugs the writer found interesting, presented as a total.

The 34 figure comes from the 2025 FDA TIDES Harvest, a review published in Pharmaceuticals in 2026. It cites 34 FDA peptide approvals between 2016 and 2024, and separately reports the total of approved oligonucleotide therapeutics at 24 since 1998. The 34 figure is quoted from an earlier source rather than counted by the authors. The window is stated, the method is stated, and the paper is indexed.

That leaves 80, a figure traced to a 2022 review in Signal Transduction and Targeted Therapy. The review counted more than 80 peptide drugs on the global market as of February 2022. Global is doing heavy lifting in that sentence. The figure includes products approved outside the United States and products no longer sold. It also counts 33 non-insulin peptide drugs approved worldwide since 2000.

No FDA-published aggregate exists to settle the argument. The agency's December 2023 draft guidance defines a peptide as a molecule of 40 or fewer amino acids regulated as a drug. That guidance states no total anywhere.

So when a site announces 14 FDA-approved peptides, it is showing you a selection. The 34 figure is sourced, dated and defined, but it counts approvals inside a nine-year window rather than everything on the market. It also stops at 2024, so it excludes elamipretide, which the same review reports as a 2025 approval.

Every FDA-approved peptide, grouped by what it treats

The tables below group drugs by therapeutic area. Years give the first US FDA approval of the ingredient, not of every brand that later carried it. A dagger (†) marks a product discontinued in the United States that remains historically approved. Accelerated approvals carry a double dagger (‡).

One thing to notice before you scroll. These tables carry 47 rows, because they count every approved peptide drug rather than approvals inside one window. Thirty-two of those rows fall outside the 2016 to 2024 window the 34 count covers, and fifteen fall inside it. The review also counts more approvals inside that window than this page lists in it. Its authors applied their own definition of a peptide therapeutic. What follows is a fuller historical record. The two measure different things, and neither one is wrong.

Diabetes, weight and metabolic

Bone, growth and hormone

Cancer and neuroendocrine

Heart, blood and clotting

Reproductive and fertility

Gut

Rare disease, infection and other

Read the years down the first table and a pattern shows itself. Metabolic peptides dominate the recent record, with semaglutide and tirzepatide each collecting new labeled uses after their first approval rather than staying put.

Older approvals cluster somewhere else entirely. Endocrinology, oncology and critical care account for most of what came before 2010. A page built only around weight-loss peptides therefore misses most of the field.

Three entries in those tables carry daggers. Fuzeon, Natrecor and Adlyxin were approved, sold, and then pulled from the US market by their manufacturers. They stay on this list because historical approval is a fact that does not expire. Their absence from pharmacy shelves also confuses people who find them on older lists.

The four newest approvals (2024-2025)

Four peptide drugs reached approval in the last two years, and most competing lists predate all four.

Pegulicianine (Lumisight) was approved on April 17, 2024. Surgeons use it as an imaging drug during breast lumpectomy, where it helps detect cancerous tissue.

Palopegteriparatide (Yorvipath) followed on August 9, 2024, for hypoparathyroidism in adults. Levacetylleucine (Aqneursa) arrived on September 24, 2024, for the neurological symptoms of Niemann-Pick disease type C.

Elamipretide (Forzinity) is the interesting one. On September 19, 2025, the FDA granted it accelerated approval as the first treatment for Barth syndrome. Accelerated approval is not the same as full approval. The agency granted it on knee-muscle strength data judged reasonably likely to predict clinical benefit, and a confirmatory trial is required. If that trial fails, the approval can be withdrawn.

Why single out a two-year window? Most FDA-approved peptide lists in this niche were written before these four existed. None of them will tell you that one of the four sits on a conditional footing.

Popular peptides that are not FDA-approved

A peptide being sold online, argued about on forums, or recommended by a committee is not the same as a peptide being FDA-approved. The compounds below are the ones people ask about most, and every one of them gets the same verdict.

BPC-157 is a synthetic peptide related to a sequence found in gastric juice. Not FDA-approved. TB-500, a fragment of the protein thymosin beta-4, is not FDA-approved either. KPV, a three-amino-acid fragment, is not FDA-approved.

Six of these compounds share a specific 2026 wrinkle. In July 2026, the FDA's Pharmacy Compounding Advisory Committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon for the 503A bulks list. A recommendation from that committee is advisory only. None of the six appears on the codified list at 21 CFR 216.23, and none is FDA-approved as of September 2026. Emideltide, also called DSIP, was reviewed and not recommended. Our breakdown of the July 2026 PCAC vote covers the tallies and what they do and do not change.

GHK-Cu, a copper-binding tripeptide complex, follows a different path and reaches the same destination. Its non-injectable form returned to Category 1 in May 2026, and the injectable nomination was withdrawn. Category 1 is a compounding category, not an approval.

Ipamorelin and CJC-1295 are both growth hormone secretagogue compounds, and neither is FDA-approved. Semax, MOTS-c and Epitalon are not approved either.

Research peptides are sold for laboratory research use only and are not for human use. A research-use label on a vial is not a drug approval. An approval held by a drug of the same name does not extend to it.

One closing point matters more than the list itself. Not approved does not mean proven dangerous, and it does not mean safe. It means the FDA has not reviewed the compound as a drug, so nobody has weighed its safety and efficacy data in that formal way. Enforcement activity has picked up around this gap, which our September 2026 peptide crackdown explainer walks through.

Sermorelin was approved once and has been gone since 2009

Sermorelin is the trickiest entry on any FDA-approved peptide list, which is why it gets a section instead of a table row.

The approval history here is entirely real. On December 28, 1990, the FDA approved NDA 19-863 for Geref at 0.05 mg per ampule. That product was a diagnostic for assessing pituitary growth hormone secretion. A second approval followed on September 26, 1997, when NDA 20-443 covered Geref at 0.5 and 1.0 mg per vial. Its labeled use was idiopathic growth hormone deficiency in children with growth failure. EMD Serono was the sponsor of both applications.

Then the company walked away from both. It discontinued the 0.05 mg product on July 11, 2008, and the vials on December 2, 2008. Withdrawal of both NDAs was requested that same December. The FDA's withdrawal of both approvals took effect on June 18, 2009.

A 2013 notice muddies things for people who find it out of context. On March 4, 2013, the Federal Register published a determination that Geref was not withdrawn for safety or effectiveness reasons. In plain terms, that ruling lets the FDA approve future generic copies referencing Geref. It did not put any sermorelin product back on the market, and no generic followed.

Current status as of September 2026 is unambiguous. Both NDAs show a marketing status of Discontinued in openFDA data, and DailyMed returns zero current labels for sermorelin. No FDA-approved sermorelin product is marketed in the United States.

Calling sermorelin FDA-approved without that qualification misleads the reader. The drug was genuinely approved once. It is not available, and it has not been for well over a decade.

Retatrutide, CagriSema and survodutide are still in trials

Three metabolic peptides get asked about as though approval already happened. None of the three is approved as of September 2026.

Retatrutide is Eli Lilly's once-weekly triple agonist, hitting GIP, GLP-1 and glucagon receptors. It is running through the phase 3 TRIUMPH program, and TRIUMPH-2 results were presented on September 29, 2026. No application has been filed with the FDA. Lilly plans a submission in the first quarter of 2027. The company describes retatrutide in its own materials as an investigational molecule that cannot be legally sold or marketed for human use.

CagriSema pairs cagrilintide, an amylin agonist, with semaglutide in one once-weekly injection from Novo Nordisk. The phase 3 REDEFINE and REIMAGINE programs cover obesity and type 2 diabetes. Novo Nordisk calls the combination investigational. The company submitted an application for weight management in December 2025, and an FDA decision is expected in the fourth quarter of 2026. No decision had been announced as of September 30, 2026.

Survodutide is a once-weekly glucagon and GLP-1 dual agonist from Boehringer Ingelheim, licensed from Zealand Pharma, now in the phase 3 SYNCHRONIZE program. It holds FDA Fast Track designation from 2021 and Breakthrough Therapy designation from September 2024 for MASH. Neither of those designations is an approval. Designations speed up review and communication, and they permit no marketing at all.

Pipeline drugs are where the next approvals come from, and a CagriSema decision could land within months of this page going live. That is exactly why the date at the top matters.

What changed in 2026

Three developments this year tightened the line between approved drugs and everything else.

On July 23 and 24, 2026, the Pharmacy Compounding Advisory Committee voted to recommend six peptides for the 503A bulks list. Those six were BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon, while emideltide was not recommended. FDA staff had recommended against all seven before the vote. As of September 22, 2026, none had been added to the codified list at 21 CFR 216.23. None was FDA-approved, and no proposed rule had appeared.

April brought a quieter change with a confusing name. The FDA moved several nominated peptides out of the Category 2 table and into a withdrawn-nominations table after the nominators pulled their submissions. Sitting in a withdrawn-nominations table is not the same as sitting in Category 1, though the two get conflated constantly. Our Category 2 and Category 1 reclassification explainer sorts out which peptide moved where.

GLP-1 compounding changed on a separate track. The tirzepatide shortage was resolved on October 2, 2024, and the semaglutide shortage on February 21, 2025. Those resolutions removed the legal basis for compounding copies of either one. Deadlines for 503A and 503B facilities to stop passed during the first half of 2025.

Each of those developments pushed in the same direction. The gap between an approved drug and an unapproved compound got harder to blur in 2026. A list of only approved drugs becomes worth keeping at exactly that moment.

Approved, compounded, investigational and research-use are four different things

Most confusion about FDA-approved peptides comes from collapsing four categories into two. Here is what separates the four.

An approved drug has been through FDA review of safety and efficacy data for a specific product and a specific labeled use. Every drug in the tables above sits here.

A compounded drug is prepared for an individual patient by a 503A pharmacy, or in batches by a 503B outsourcing facility. Those rules do not include premarket approval. Compounded drugs are not FDA-approved, even when they copy the active ingredient of a drug that is. Semaglutide and tirzepatide copies are the clearest recent case, and our guide to their current legal status explains what changed once the shortages ended.

An investigational drug is in clinical trials. Retatrutide, CagriSema and survodutide are the examples on this page, and none of them can be legally sold or marketed for human use.

A research-use-only chemical is sold for laboratory work and is not for human use. The RUO label does not make a compound a drug. An approval held by a drug with the same name never reaches across to it. Our overview of RUO compliance in the United States covers where that line sits.

The practical rule here is a short one. Match the claim to the bucket. A committee vote, a Category 1 listing, or a positive trial result never moves a peptide into the approved bucket.

How to verify any peptide's status yourself

Four public databases answer this question without any interpretation from a vendor or a blog.

Drugs@FDA holds the full approval history. Search the ingredient name, then read the approval dates and the marketing status attached to each application.

DailyMed holds the current product labels. A current label means a marketed product exists. Zero labels, which is what sermorelin returns today, means nothing is currently marketed under that ingredient.

The Orange Book's Discontinued Drug Product List captures the middle case, showing drugs that were approved and are no longer sold.

Withdrawal determinations and notices tied to advisory committee activity appear in the Federal Register, including the PCAC material discussed above.

One caution applies across all four. A discontinued listing proves historical approval and nothing about current availability. An active listing proves a marketed product exists, not that a given seller's version is that product.

The bottom line

Three numbers circulate for FDA-approved peptides, and only one of them carries a checkable definition. This page uses its own table as the list, and cites 34 only as a sourced count of approvals in one window. The tables use a wider standard and reach back to 1960.

None of the peptides sold as research chemicals appears on either list. BPC-157, TB-500, KPV, GHK-Cu, ipamorelin, CJC-1295, Semax, MOTS-c and Epitalon are all unapproved as of September 2026, whatever a committee recommended in July.

Check the date at the top before relying on any of this. A CagriSema decision is expected in the fourth quarter of 2026, and one approval would change both the tables and the pipeline section.

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