Which Peptides Are FDA-Approved? Complete List

When someone mentions "peptides," the conversation often drifts toward research compounds -- BPC-157, CJC-1295, TB-500, and the like. But these are not FDA-approved drugs. They occupy a legal gray area that the FDA has been closing rapidly since 2024.

When someone mentions "peptides," the conversation often drifts toward research compounds -- BPC-157, CJC-1295, TB-500, and the like. But these are not FDA-approved drugs. They occupy a legal gray area that the FDA has been closing rapidly since 2024.

What many people do not realize is that dozens of peptide drugs already have full FDA approval. Semaglutide (Ozempic, Wegovy) gets the headlines, but the history of FDA-approved peptides stretches back decades. Insulin was the first, isolated in 1921 and commercially available by the early 1920s. Since then, the FDA has authorized roughly 100 peptide-based therapeutics covering diabetes, cancer, osteoporosis, growth hormone deficiency, sexual dysfunction, rare genetic conditions, and more.

This article provides a comprehensive, category-by-category list of FDA-approved peptide drugs with their brand names, indications, and approval dates. If you want to know whether a specific peptide is legal for medical use in the United States, this is the reference.


Table of Contents


What Makes a Peptide "FDA-Approved"

An FDA-approved peptide drug has gone through the full regulatory process: preclinical studies, Phase 1/2/3 clinical trials, a New Drug Application (NDA) or Biologics License Application (BLA), and FDA review. The approval means the FDA has determined the drug is safe and effective for its approved indication(s) when used as directed.

This matters because many peptides sold online or through compounding pharmacies have never completed this process. "Research use only" peptides, "gray market" peptides, and compounded peptides (where the active ingredient is not itself FDA-approved) exist outside this framework.

A peptide being FDA-approved does not mean it is approved for every possible use. Semaglutide, for example, is approved for type 2 diabetes and chronic weight management -- not for anti-aging or cognitive enhancement, even though some providers prescribe it off-label.

The THPdb2 database, maintained by researchers at the CSIR-Institute of Microbial Technology, catalogs 894 FDA-approved therapeutic proteins, including 85 peptides and polypeptides. The Purdue University CDEK database provides another searchable index of FDA-approved peptide products.


GLP-1 and Incretin-Based Peptides (Diabetes and Weight Management)

This is the category that changed public perception of peptides. The GLP-1 receptor agonist class has become one of the most commercially successful drug categories in pharmaceutical history, with the peptide therapeutics market projected to reach $49.68 billion in 2026.

Generic NameBrand Name(s)FDA ApprovalIndications
ExenatideByetta, Bydureon2005 (Byetta), 2012 (Bydureon)Type 2 diabetes
LiraglutideVictoza, Saxenda2010 (Victoza), 2014 (Saxenda)Type 2 diabetes, chronic weight management
LixisenatideAdlyxin2016Type 2 diabetes
SemaglutideOzempic, Rybelsus, Wegovy2017 (Ozempic), 2019 (Rybelsus), 2021 (Wegovy), 2025 (oral Wegovy)Type 2 diabetes, chronic weight management, CV risk reduction, CKD risk reduction
DulaglutideTrulicity2014Type 2 diabetes, CV risk reduction
TirzepatideMounjaro, Zepbound2022 (Mounjaro), 2023 (Zepbound)Type 2 diabetes, chronic weight management, obstructive sleep apnea (2024)

Key Details

Semaglutide is a 31-amino acid peptide analog of human GLP-1 with 94% sequence homology to the native hormone. Ozempic was first approved December 5, 2017. In January 2025, it received an expanded indication to reduce kidney disease progression in patients with type 2 diabetes and CKD. In December 2025, the FDA approved the first oral semaglutide for weight management (Wegovy 25 mg tablets), making it the first oral GLP-1 pill indicated for obesity.

Tirzepatide is a dual GIP/GLP-1 receptor agonist -- the first in its class. The SURMOUNT trials demonstrated up to 22.5% body weight reduction. In December 2024, Zepbound was approved for moderate-to-severe obstructive sleep apnea in adults with obesity.

Liraglutide was the second GLP-1 agonist approved. Saxenda was the first GLP-1 specifically approved for weight management (2014).

Exenatide was the original GLP-1 drug, derived from a compound found in Gila monster saliva (exendin-4). Bydureon BCise, the once-weekly formulation, simplified dosing.

See also: Semaglutide vs. Tirzepatide comparison, Ozempic vs. Wegovy, Branded GLP-1 drugs market comparison


Growth Hormone and GHRH Analogs

Generic NameBrand Name(s)FDA ApprovalIndications
Somatropin (recombinant hGH)Genotropin, Humatrope, Norditropin, Saizen, Nutropin, OmnitropeVarious (1987-2006)Growth hormone deficiency (pediatric and adult), Turner syndrome, Prader-Willi syndrome, short bowel syndrome, HIV wasting
TesamorelinEgrifta, Egrifta SV2010HIV-associated lipodystrophy
SermorelinGeref1997 (discontinued by manufacturer)Diagnostic agent for GH deficiency; still available through compounding
SomapacitanSogroya2020Adult growth hormone deficiency (once-weekly)
LonapegsomatropinSkytrofa2021Pediatric growth hormone deficiency (once-weekly)

Key Details

Tesamorelin is a 44-amino acid GHRH analog. It remains the only FDA-approved GHRH analog currently marketed, approved specifically for reducing excess abdominal fat in HIV-infected patients with lipodystrophy. See the tesamorelin clinical trials review.

Sermorelin was FDA-approved as a diagnostic agent, but the commercial product (Geref) was discontinued by its manufacturer. However, sermorelin remains available through compounding pharmacies because it meets the criteria for compounding (it was an active ingredient in an FDA-approved drug). This makes it one of the few GHRH analogs still legally available through compounding. See CJC-1295 vs. sermorelin comparison.

Somatropin is recombinant human growth hormone, a 191-amino acid protein. Multiple branded versions exist. Prescription is restricted to documented GH deficiency and specific conditions.


GnRH Analogs (Reproductive and Oncology)

Gonadotropin-releasing hormone (GnRH) analogs are among the most widely used peptide drugs in oncology and reproductive medicine.

Generic NameBrand Name(s)FDA ApprovalIndications
LeuprolideLupron, Lupron Depot, Eligard, Fensolvi1985Prostate cancer, endometriosis, uterine fibroids, central precocious puberty
GoserelinZoladex1989Prostate cancer, breast cancer, endometriosis
NafarelinSynarel1990Endometriosis, central precocious puberty
HistrelinSupprelin LA, Vantas2004 (Supprelin), 2004 (Vantas)Central precocious puberty, prostate cancer
DegarelixFirmagon2008Advanced prostate cancer
GonadorelinLutrepulse (discontinued)1982Diagnostic; hypothalamic amenorrhea
ElagolixOrilissa2018Endometriosis pain
RelugolixOrgovyx2020Advanced prostate cancer (first oral GnRH antagonist)
LinzagolixYselty2024Uterine fibroids

Key Details

Leuprolide was one of the earliest approved peptide drugs (April 9, 1985). It is a synthetic nonapeptide analog of GnRH. Lupron Depot, the long-acting formulation, is one of the most prescribed peptide drugs in the world.

Degarelix is a GnRH antagonist (not agonist), which means it blocks GnRH receptors immediately rather than causing an initial surge. This makes it useful in prostate cancer cases where a testosterone flare could be dangerous.

Relugolix (Orgovyx) was the first oral GnRH antagonist for prostate cancer, eliminating the need for injections.


Somatostatin Analogs

Generic NameBrand Name(s)FDA ApprovalIndications
OctreotideSandostatin, Sandostatin LAR, Mycapssa1988 (injectable), 2020 (Mycapssa oral)Acromegaly, carcinoid syndrome, VIPomas
LanreotideSomatuline Depot2007Acromegaly, gastroenteropancreatic neuroendocrine tumors
PasireotideSignifor, Signifor LAR2012Cushing's disease, acromegaly

Key Details

Octreotide is an octapeptide (8 amino acids) that mimics somatostatin. Initially approved October 21, 1988, it is now available in injectable and oral (Mycapssa, approved 2020) forms. Mycapssa was the first oral somatostatin analog, a significant advance for patients requiring long-term treatment.

Lanreotide is administered as a deep subcutaneous injection every 4 weeks, providing a longer-acting alternative to standard octreotide.


Bone and Calcium Metabolism Peptides

Generic NameBrand Name(s)FDA ApprovalIndications
TeriparatideForteo, Bonsity2002 (Forteo), 2019 (Bonsity biosimilar)Osteoporosis (high fracture risk)
AbaloparatideTymlos2017Osteoporosis in postmenopausal women
Calcitonin (salmon)Miacalcin, Fortical1995 (nasal), 2005 (updated)Osteoporosis, Paget's disease, hypercalcemia
Elcatonin(Available in other countries)Not FDA-approved in U.S.--

Key Details

Teriparatide is the first 34 amino acids of human parathyroid hormone (PTH 1-34). Unlike most osteoporosis drugs that slow bone loss, teriparatide actually stimulates new bone formation -- it is anabolic rather than anti-resorptive. It was approved in November 2002.

Abaloparatide is a synthetic analog of PTH-related protein (PTHrP). It shares teriparatide's bone-building mechanism but may have a more favorable side effect profile regarding hypercalcemia.


Cardiovascular and Hematologic Peptides

Generic NameBrand Name(s)FDA ApprovalIndications
VasopressinVasostrict2014Vasodilatory shock
NesiritideNatrecor2001Acute decompensated heart failure
BivalirudinAngiomax2000Anticoagulation during PCI
EptifibatideIntegrilin1998Acute coronary syndrome, PCI
IcatibantFirazyr2011Hereditary angioedema attacks

Key Details

Vasopressin has an unusual regulatory history. The peptide was isolated and marketed in the U.S. as early as 1928, but no manufacturer sought formal FDA approval until Par Pharmaceutical did so in 2014. It is a 9-amino acid peptide critical in ICU settings for managing septic shock.

Bivalirudin is a synthetic 20-amino acid peptide that directly inhibits thrombin. It largely replaced heparin in many cardiac catheterization procedures because of its more predictable pharmacokinetics.


Gastrointestinal Peptides

Generic NameBrand Name(s)FDA ApprovalIndications
LinaclotideLinzess2012IBS-C, chronic idiopathic constipation
PlecanatideTrulance2017Chronic idiopathic constipation, IBS-C
TeduglutideGattex2012Short bowel syndrome
GlucagonGlucaGen, Baqsimi (nasal)1998 (injectable), 2019 (nasal)Severe hypoglycemia
SecretinSecreFlo2004Diagnostic (pancreatic function, gastrinoma)
Larazotide(Not yet approved)Phase 3Celiac disease (investigational)

Key Details

Linaclotide is a 14-amino acid peptide that activates guanylate cyclase-C receptors in the intestinal epithelium. It was a breakthrough for IBS-C treatment when approved in 2012.

Teduglutide is a GLP-2 analog (different from the GLP-1 drugs used for diabetes/weight loss). It promotes intestinal growth and is used in patients with short bowel syndrome who are dependent on parenteral nutrition.


Neurological and Rare Disease Peptides

Generic NameBrand Name(s)FDA ApprovalIndications
DesmopressinDDAVP, Stimate, Nocdurna1978Diabetes insipidus, nocturnal enuresis, von Willebrand disease
ZiconotidePrialt2004Severe chronic pain (intrathecal)
DifelikefalinKorsuva2021Pruritus in hemodialysis patients
TrofinetideDaybue2023Rett syndrome
VoclosporinLupkynis2021Lupus nephritis
Elamipretide(Barth syndrome)2025Barth syndrome

Key Details

Desmopressin is a synthetic analog of vasopressin (antidiuretic hormone). First approved in 1978, it has one of the longest track records of any peptide drug. It is a 9-amino acid peptide with two modifications from natural vasopressin that extend its duration of action.

Trofinetide (Daybue) was approved in March 2023 as the first treatment ever for Rett syndrome, a rare neurodevelopmental disorder. It is a tripeptide -- only three amino acids -- making it one of the shortest FDA-approved peptide drugs.

Elamipretide was approved in 2025 for Barth syndrome, becoming the first disease-specific treatment for this rare mitochondrial condition. It targets the inner mitochondrial membrane.

Ziconotide is derived from the venom of the marine cone snail Conus magus. It must be administered directly into the spinal fluid (intrathecally) and is reserved for severe, intractable pain.


Melanocortin-Based Peptides

Generic NameBrand Name(s)FDA ApprovalIndications
BremelanotideVyleesi2019Hypoactive sexual desire disorder (HSDD) in premenopausal women
SetmelanotideImcivree2020Obesity due to POMC, PCSK1, or LEPR deficiency
CosyntropinCortrosyn1970Diagnostic (adrenal insufficiency)
AfamelanotideScenesse2019Erythropoietic protoporphyria

Key Details

Bremelanotide (Vyleesi) was approved June 21, 2019, for HSDD in premenopausal women. It is a melanocortin-4 receptor agonist and the first peptide drug approved for female sexual dysfunction. It is related to Melanotan II and PT-141 (its development name). See PT-141 FDA approval studies breakdown.

Setmelanotide (Imcivree) targets MC4 receptors to reduce hunger in patients with specific rare genetic obesity disorders. It was approved in 2020 and represents a precision medicine approach -- it works only in patients with documented POMC, PCSK1, or LEPR gene mutations.

Afamelanotide is a synthetic analog of alpha-MSH that increases eumelanin production in the skin. It was approved for erythropoietic protoporphyria (EPP), a painful condition caused by light sensitivity.


Anti-Infective and Immune Peptides

Generic NameBrand Name(s)FDA ApprovalIndications
VancomycinVancocin1958Serious Gram-positive infections, C. difficile colitis
DaptomycinCubicin2003Complicated skin infections, bacteremia
TelavancinVibativ2009Hospital-acquired pneumonia, skin infections
OritavancinOrbactiv2014Acute bacterial skin infections
DalbavancinDalvance2014Acute bacterial skin infections
EnfuvirtideFuzeon2003HIV-1 (fusion inhibitor)
PegcetacoplanEmpaveli2021Paroxysmal nocturnal hemoglobinuria

Key Details

Vancomycin is a glycopeptide antibiotic and one of the oldest FDA-approved peptide-derived drugs. It was first approved in 1958, long before modern peptide drug development.

Enfuvirtide (Fuzeon) is a 36-amino acid synthetic peptide that blocks HIV-1 fusion with host cells. It requires twice-daily subcutaneous injection, which limits its use, but it represented a novel mechanism of action when approved.

Pegcetacoplan contains two copies of a tridecapeptide conjugated to polyethylene glycol (PEG). It inhibits complement C3 and was approved for PNH in 2021.


Other FDA-Approved Peptide Drugs

Generic NameBrand Name(s)FDA ApprovalIndications
OxytocinPitocin1980Labor induction, postpartum hemorrhage
CarbetocinDuratocin(Not FDA-approved in U.S.; WHO essential medicine)Postpartum hemorrhage prevention
CyclosporineSandimmune, Neoral, Restasis1983Organ transplant rejection, autoimmune conditions, dry eye
CarfilzomibKyprolis2012Multiple myeloma
BortezomibVelcade2003Multiple myeloma, mantle cell lymphoma
PramlintideSymlin2005Type 1 and type 2 diabetes (amylin analog)
ZilucoplanZilbrysq2023Generalized myasthenia gravis
MotixafortideAphexda2023Hematopoietic stem cell mobilization
PaltusotineMycapssa (oral)2020Acromegaly (maintenance)

Key Details

Oxytocin (Pitocin) is the most widely administered peptide drug in the world by volume. It is a 9-amino acid cyclic peptide used in virtually every hospital labor and delivery unit. See our oxytocin science guide.

Cyclosporine is technically a cyclic undecapeptide (11 amino acids) derived from a fungus. It revolutionized organ transplantation when approved in 1983 by providing the first effective immunosuppressant that did not broadly destroy bone marrow.

Pramlintide is a synthetic analog of amylin, a peptide hormone co-secreted with insulin by pancreatic beta cells. It is used alongside insulin in patients with diabetes.


Recent Approvals: 2023-2025

The pace of peptide drug approvals has accelerated. Here are the most notable recent additions:

2023

  • Trofinetide (Daybue) -- First-ever treatment for Rett syndrome. Oral tripeptide.
  • Zilucoplan (Zilbrysq) -- Complement C5 inhibitor for generalized myasthenia gravis. Subcutaneous injection.
  • Motixafortide (Aphexda) -- First peptide CXCR4 antagonist for stem cell mobilization.
  • Zepbound (tirzepatide) -- Tirzepatide approved for chronic weight management (November 2023).

2024

  • Zepbound expanded indication -- Tirzepatide approved for obstructive sleep apnea in adults with obesity (December 2024).
  • Linzagolix (Yselty) -- Oral GnRH antagonist for uterine fibroids.

2025

  • Elamipretide -- First disease-specific treatment for Barth syndrome. Targets the inner mitochondrial membrane.
  • Oral Wegovy (semaglutide 25 mg) -- First oral GLP-1 pill for weight management (December 2025).
  • Ozempic expanded indication -- Semaglutide approved for CKD risk reduction in type 2 diabetes (January 2025).

The Pipeline: Peptides Nearing Approval

Several peptide drugs are in late-stage clinical trials and may receive FDA approval in the coming years:

PeptideClassPhaseTarget Indication
RetatrutideTriple agonist (GIP/GLP-1/glucagon)Phase 3Obesity, type 2 diabetes
SurvodutideDual agonist (GLP-1/glucagon)Phase 3NASH/MASH, obesity
OrforglipronOral GLP-1 agonistPhase 3Type 2 diabetes, obesity
CagriSemaSemaglutide + cagrilintidePhase 3Obesity
PemvidutideDual agonist (GLP-1/glucagon)Phase 2NASH
MazdutideDual agonist (GLP-1/glucagon)Phase 3Type 2 diabetes, obesity

Retatrutide is the most closely watched candidate. As a triple agonist (GIP, GLP-1, and glucagon receptors), Phase 2 data showed up to 24.2% body weight loss at 48 weeks. Eli Lilly is conducting multiple Phase 3 trials, with potential FDA approval expected in 2027-2028. See also tirzepatide vs. retatrutide comparison.

Orforglipron is notable because it is an oral, non-peptide GLP-1 agonist -- a small molecule that mimics GLP-1's effects without being a peptide itself. Eli Lilly's Phase 3 trials are underway. See the orforglipron Phase 3 updates.


Common Peptides That Are NOT FDA-Approved

To clear up common confusion, here are popular peptides that people frequently assume are FDA-approved but are not:

PeptideStatusWhy People Confuse It
BPC-157Not approved; Category 2Widely used in compounding before 2024
TB-500 (Thymosin Beta-4)Not approved; Category 2Commonly compounded for tissue repair
CJC-1295Not approved; under PCAC reviewPopular GH secretagogue
IpamorelinNot approved; under PCAC reviewOften stacked with CJC-1295
Thymosin Alpha-1Not FDA-approved; approved in some other countries (as Zadaxin)Approved outside U.S. causes confusion
AOD-9604Not approvedMarketed for fat loss
MK-677Not approved; technically not a peptide (small molecule)Sold alongside peptides; acts on GH pathway
SelankNot approved; approved in RussiaRussian approval causes confusion
SemaxNot approved; approved in RussiaSame issue as Selank
Melanotan IINot approved; Category 2Widely sold online for tanning
DSIPNot approvedUsed for sleep; no human trials
EpitalonNot approvedRussian research only
GHK-Cu (injectable)Not approved for injectionTopical GHK-Cu is Category 1; injectable is not

If a peptide is not in the tables above, it is very likely not FDA-approved. The definitive source is the FDA's Drugs@FDA database, which you can search at accessdata.fda.gov/scripts/cder/daf/.


FAQ

How many peptides has the FDA approved in total?

Roughly 80-100, depending on how you count. The THPdb2 database catalogs 85 peptides and polypeptides among the 894 FDA-approved therapeutic proteins. The exact number depends on whether you include glycopeptide antibiotics, cyclic peptides like cyclosporine, and peptide-drug conjugates.

Is insulin a peptide?

Insulin is a 51-amino acid protein composed of two peptide chains (A chain: 21 amino acids, B chain: 30 amino acids) linked by disulfide bonds. It is often classified as a small protein rather than a peptide, but the line between "large peptide" and "small protein" is somewhat arbitrary. Insulin is typically categorized as a protein therapeutic rather than a peptide drug.

Can my doctor prescribe an FDA-approved peptide off-label?

Yes. Once a drug is FDA-approved, physicians can prescribe it for any condition they believe it may benefit, even if that condition is not an approved indication. Off-label prescribing is legal and common. However, insurance typically only covers on-label indications.

What is the difference between FDA-approved and compounded peptides?

FDA-approved peptides have gone through clinical trials, manufacturing inspections, and regulatory review. Compounded peptides are mixed by pharmacies, sometimes using the same active ingredient as an approved drug, sometimes using substances that have never been approved. The FDA's current regulatory actions target the latter category. See the compounded vs. brand-name semaglutide comparison.

Are any anti-aging peptides FDA-approved?

No peptide has been approved specifically for "anti-aging." However, several approved peptides have effects relevant to aging: teriparatide for osteoporosis (bone aging), semaglutide for obesity-related conditions, and growth hormone for adult GH deficiency. Read more in our best peptides for anti-aging guide.

Will more peptides be approved in the future?

Almost certainly. Peptide drugs now account for roughly 10% of new FDA approvals each year, and the pipeline includes dozens of candidates. The trend is toward oral formulations, longer-acting versions, and multi-receptor agonists. The peptide therapeutics market is projected to grow to $106 billion by 2033.


The Bottom Line

The list of FDA-approved peptide drugs is far longer than most people realize. From the earliest hormone replacements to the latest weight management drugs, peptides have been part of mainstream medicine for decades.

The distinction that matters right now is between FDA-approved peptide drugs -- which can be prescribed, dispensed, and used with well-characterized safety profiles -- and the research peptides and compounded formulations that have come under increasing regulatory scrutiny since 2024.

If you are considering any peptide therapy, the first question to ask is whether the peptide in question is FDA-approved for any indication. If it is, you have a regulated, quality-controlled product with known risks and benefits that you can discuss with your physician. If it is not, you are in territory where safety data may be limited, legal status is uncertain, and access is tightening.

The resources to check: the FDA's Drugs@FDA database, the THPdb2 database for the academic catalog, and PeptideJournal.org's individual peptide profiles for detailed science on any specific compound.


References

  1. Al Musaimi O. "2024 FDA TIDES (Peptides and Oligonucleotides) Harvest." Pharmaceuticals. 2025;19(2):244. https://pmc.ncbi.nlm.nih.gov/articles/PMC11945313/
  2. Al Musaimi O. "2023 FDA TIDES (Peptides and Oligonucleotides) Harvest." Pharmaceuticals. 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC10893093/
  3. Al Musaimi O. "2025 FDA TIDES (Peptides and Oligonucleotides) Harvest." Pharmaceuticals. 2026;19(2):244. https://www.mdpi.com/1424-8247/19/2/244
  4. Usmani SS et al. "THPdb: Database of FDA-approved peptide and protein therapeutics." PLOS ONE. 2017. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181748
  5. Sharma A et al. "THPdb2: compilation of FDA approved therapeutic peptides and proteins." Drug Discovery Today. 2024. https://www.sciencedirect.com/science/article/abs/pii/S1359644624001727
  6. Purdue University CDEK. "FDA Approvals: Peptide." https://cdek.pharmacy.purdue.edu/fda-approvals/Peptide/
  7. Apostolopoulos V et al. "Exploring FDA-Approved Frontiers: Insights into Natural and Engineered Peptide Analogues in the GLP-1, GIP, GHRH, CCK, ACTH, and alpha-MSH Realms." Biomolecules. 2024;14(3):264. https://pmc.ncbi.nlm.nih.gov/articles/PMC10968328/
  8. FDA. "Drugs@FDA: FDA-Approved Drugs." https://www.accessdata.fda.gov/scripts/cder/daf/
  9. Al Musaimi O. "FDA's stamp of approval: Unveiling peptide breakthroughs in cardiovascular diseases, ACE, HIV, CNS, and beyond." Journal of Peptide Science. 2024. https://onlinelibrary.wiley.com/doi/full/10.1002/psc.3627
  10. Holt Law. "Deep Dive: Regulatory Status of Popular Compounded Peptides." https://djholtlaw.com/deep-dive-regulatory-status-of-popular-compounded-peptides/