Source: Drugs@FDA via openFDA. Each peptide is looked up by FDA active-ingredient name, which includes withdrawn and discontinued products, so a peptide shown as never approved genuinely has no FDA drug record. Last refreshed November 2, 2026.
Which peptides are FDA-approved?
A complete list verified against the FDA’s own Drugs@FDA database — including the peptides that never were.
Short answer: Of 139 peptides tracked on this site, 56 are currently FDA-approved prescription drugs, 9 were approved by the FDA but have since been discontinued or withdrawn, and 74 have no FDA approval at all. Widely sold research peptides including BPC-157, TB-500, and CJC-1295 fall in that last group: they have never been approved by the FDA for human use.
56FDA-approved
9approved, then discontinued
74never approved
FDA-approved peptide drugs (56)
Peptides with at least one currently marketed, FDA-approved prescription product.
| Peptide | Brand name(s) | First approved |
|---|---|---|
| Abaloparatide | TYMLOS | Apr 2017 |
| Approved for: TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available…NDA208743 | ||
| Afamelanotide | SCENESSE | Oct 2019 |
| Approved for: SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).…NDA210797 | ||
| Angiotensin-Ii | ANGIOTENSIN ll ACETATE, GIAPREZA | Dec 2017 |
| Approved for: Angiotensin II Injection increases blood pressure in adults with septic or other distributive shock. Angiotensin II Injection is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. (1)ANDA216966, NDA209360 | ||
| Bivalirudin | ANGIOMAX, ANGIOMAX RTU, BIVALIRUDIN +1 more | Dec 2000 |
| Approved for: Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and…ANDA090189, ANDA090811, ANDA090816 · 1 FDA recall record, most recent 2023 | ||
| Bremelanotide | VYLEESI (AUTOINJECTOR) | Jun 2019 |
| Approved for: VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due…NDA210557 | ||
| Calcitonin | CALCIMAR, CALCITONIN-SALMON, CIBACALCIN +2 more | Apr 1978 |
| Approved for: Calcitonin salmon injection, synthetic is a calcitonin, indicated for the following conditions: Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable ( 1.1 ) Treatment of hypercalcemia ( 1.2 )…ANDA073690, ANDA076396, ANDA076979 · 2 FDA recall records, most recent 2023 | ||
| Cetrorelix | CETRORELIX ACETATE, CETROTIDE | Aug 2000 |
| Approved for: Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.ANDA214540, ANDA215737, ANDA217776 · 1 FDA recall record, most recent 2020 | ||
| Corticorelin | ACTHREL | May 1996 |
| BLA020162 | ||
| Corticotropin | ACTH, ACTHAR, ACTHAR GEL +5 more | Jul 1950 |
| Approved for: USES TAKE 15 MINUTES BEFORE MEALSANDA088772, NDA007504, NDA008317 | ||
| Cosyntropin | CORTROSYN, COSYNTROPIN | Apr 1970 |
| Approved for: Cosyntropin for Injection is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency.…ANDA090574, ANDA202147, NDA016750 | ||
| Degarelix | DEGARELIX ACETATE, FIRMAGON | Dec 2008 |
| Approved for: FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )ANDA215791, NDA022201 | ||
| Desmopressin In shortage | CONCENTRAID, DDAVP, DDAVP (NEEDS NO REFRIGERATION) +5 more | Feb 1978 |
| Approved for: Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma…ANDA074574, ANDA074575, ANDA074830 · 1 FDA recall record, most recent 2022 | ||
| Difelikefalin | DIFELIKEFALIN ACETATE, KORSUVA | Aug 2021 |
| Approved for: KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).…ANDA220919, NDA214916 | ||
| Dulaglutide Boxed warning | TRULICITY | Sep 2014 |
| Approved for: TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.…BLA125469 · 2 FDA recall records, most recent 2022 | ||
| Ecallantide Boxed warning | KALBITOR | Dec 2009 |
| Approved for: KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.…BLA125277 · 1 FDA recall record, most recent 2017 | ||
| Elamipretide | FORZINITY | Sep 2025 |
| Approved for: FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.…NDA215244 | ||
| Etelcalcetide | PARSABIV | Feb 2017 |
| Approved for: PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.…NDA208325 | ||
| Exenatide | BYDUREON, BYDUREON BCISE, BYDUREON PEN +2 more | Apr 2005 |
| Approved for: BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • BYETTA contains exenatide.…ANDA206697, NDA021773, NDA021919 · 1 FDA recall record, most recent 2026 | ||
| Ganirelix | FYREMADEL, GANIRELIX ACETATE | Jul 1999 |
| Approved for: Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.ANDA204246, ANDA212613, ANDA214996 · 1 FDA recall record, most recent 2025 | ||
| Glatiramer Boxed warning | COPAXONE, GLATIRAMER ACETATE, GLATOPA | Dec 1996 |
| Approved for: Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.…ANDA090218, ANDA091646, ANDA203857 · 3 FDA recall records, most recent 2013 | ||
| Glucagon | BAQSIMI, GLUCAGEN, GLUCAGON +4 more | Nov 1960 |
| Approved for: Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: • for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.…ANDA071022, ANDA071023, ANDA204468 · 1 FDA recall record, most recent 2026 | ||
| Goserelin | ZOLADEX | Dec 1989 |
| Approved for: ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Palliative treatment of advanced carcinoma of the prostate…NDA019726, NDA020515, NDA020578 · 1 FDA recall record, most recent 2026 | ||
| Histrelin | SUPPRELIN, SUPPRELIN LA, VANTAS | Dec 1991 |
| Approved for: SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).…NDA019836, NDA021732, NDA022058 | ||
| Icatibant Discontinuing | FIRAZYR, ICATIBANT ACETATE | Aug 2011 |
| Approved for: SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.…ANDA208317, ANDA210118, ANDA211021 | ||
| Insulin Discontinuing | ADMELOG, ADMELOG SOLOSTAR, AFREZZA +5 more | Oct 1982 |
| Approved for: ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes…BLA018780, BLA018781, BLA019717 · 12 FDA recall records, 8 Class I, most recent 2026 | ||
| Insulin-Aspart | FIASP, FIASP FLEXTOUCH, FIASP PENFILL +5 more | Jun 2000 |
| Approved for: NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes…BLA020986, BLA021172, BLA021810 · 3 FDA recall records, 3 Class I, most recent 2021 | ||
| Insulin-Degludec Boxed warning | RYZODEG 70/30, TRESIBA, XULTOPHY 100/3.6 | Sep 2015 |
| Approved for: XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.…BLA203313, BLA203314, BLA208583 · 4 FDA recall records, 4 Class I, most recent 2021 | ||
| Insulin-Detemir | LEVEMIR, LEVEMIR FLEXPEN, LEVEMIR FLEXTOUCH +2 more | Jun 2005 |
| Approved for: LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis.…BLA021536, BLA021878 | ||
| Insulin-Glargine | BASAGLAR, LANGLARA, LANTUS +5 more | Apr 2000 |
| Approved for: BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.…BLA021081, BLA205692, BLA206538 | ||
| Insulin-Glulisine | APIDRA, APIDRA SOLOSTAR | Apr 2004 |
| Approved for: APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes…BLA021629 | ||
| Insulin-Lispro | ADMELOG, ADMELOG SOLOSTAR, HUMALOG +5 more | Jun 1996 |
| Approved for: ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes…BLA020563, BLA021017, BLA021018 · 4 FDA recall records, 1 Class I, most recent 2024 | ||
| Lanreotide | LANREOTIDE ACETATE, SOMATULINE DEPOT | Aug 2007 |
| Approved for: Lanreotide Injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.…ANDA217193, ANDA218217, NDA022074 · 3 FDA recall records, most recent 2026 | ||
| Leuprolide Discontinuing | CAMCEVI ETM, CAMCEVI KIT, ELIGARD KIT +5 more | Apr 1985 |
| Approved for: VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )ANDA074728, ANDA075471, ANDA075721 · 6 FDA recall records, most recent 2023 | ||
| Linaclotide | LINACLOTIDE, LINZESS | Aug 2012 |
| ANDA209564, ANDA209611, ANDA211255 | ||
| Liraglutide In shortage Boxed warning | LIRAGLUTIDE, SAXENDA, VICTOZA +1 more | Jan 2010 |
| Approved for: Liraglutide injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus Limitations of Use: Liraglutide injection contains…ANDA212552, ANDA212972, ANDA213155 · 4 FDA recall records, 1 Class I, most recent 2026 | ||
| Lixisenatide | ADLYXIN, SOLIQUA 100/33 | Jul 2016 |
| Approved for: SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.…BLA208471, BLA208673 | ||
| Nafarelin | SYNAREL | Feb 1990 |
| Approved for: FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes.…NDA019886 | ||
| Octreotide | BYNFEZIA PEN, MYCAPSSA, OCTREOTIDE ACETATE +4 more | Oct 1988 |
| Approved for: Octreotide Acetate Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1;…ANDA075957, ANDA075959, ANDA076313 · 5 FDA recall records, 1 Class I, most recent 2026 | ||
| Oxytocin | OXYTOCIN, OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5% +3 more | Apr 1980 |
| Approved for: USES TAKE 15 MINUTES BEFORE MEALSANDA077453, ANDA091676, ANDA200219 · 1 FDA recall record, most recent 2012 | ||
| Pasireotide | SIGNIFOR, SIGNIFOR LAR KIT | Dec 2012 |
| Approved for: SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative ( 1 ) 1.1 Cushing's Disease SIGNIFOR is indicated for the treatment…NDA200677, NDA203255 | ||
| Plecanatide Boxed warning | TRULANCE | Jan 2017 |
| Approved for: TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C).…NDA208745 | ||
| Secretin | CHIRHOSTIM, PORCINE SECRETIN, SECREFLO +1 more | Apr 2002 |
| Approved for: ChiRhoStim ® is indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.…NDA018290, NDA021136, NDA021209 | ||
| Semaglutide Discontinuing Boxed warning | OZEMPIC, RYBELSUS, SEMAGLUTIDE +3 more | Dec 2017 |
| Approved for: RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.…ANDA220314, NDA209637, NDA213051 · 1 FDA recall record, most recent 2021 | ||
| Setmelanotide | IMCIVREE | Nov 2020 |
| Approved for: IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged [ see Dosage and Administration (2.1) ]: 4 years and older with acquired hypothalamic obesity (HO) 2 years and…NDA213793 | ||
| Sincalide | KINEVAC, SINCALIDE | Jul 1976 |
| Approved for: Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile…NDA017697, NDA210850 · 1 FDA recall record, most recent 2022 | ||
| Somatropin Discontinuing | ACCRETROPIN, BIO-TROPIN, GENOTROPIN +5 more | Oct 1986 |
| Approved for: NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan…BLA019640, BLA019676, BLA019764 · 1 FDA recall record, most recent 2016 | ||
| Somatropin-Recombinant | ZORBTIVE | Dec 2003 |
| BLA021597 | ||
| Teduglutide | GATTEX KIT | Dec 2012 |
| Approved for: GATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support .…NDA203441 | ||
| Teriparatide | BONSITY, FORTEO, PARATHAR +1 more | Nov 2002 |
| Approved for: Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have…ANDA208569, ANDA211097, ANDA213641 | ||
| Terlipressin | TERLIVAZ | Sep 2022 |
| NDA022231 · 1 FDA recall record, most recent 2024 | ||
| Tesamorelin | EGRIFTA | Nov 2010 |
| Approved for: EGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established.…BLA022505 | ||
| Tirzepatide Boxed warning | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN +3 more | May 2022 |
| Approved for: MOUNJARO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.…NDA215866, NDA217806 | ||
| Triptorelin | TRELSTAR, TRIPTODUR KIT | Jun 2000 |
| Approved for: TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )NDA020715, NDA021288, NDA022437 | ||
| Vasopressin | PITRESSIN TANNATE, VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5% +2 more | Apr 2014 |
| Approved for: Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.…ANDA211538, ANDA211857, ANDA212068 · 4 FDA recall records, most recent 2026 | ||
| Vosoritide | VOXZOGO | Nov 2021 |
| Approved for: VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical…NDA214938 | ||
| Ziconotide Boxed warning | PRIALT | Dec 2004 |
| Approved for: PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as…NDA021060 | ||
Approved by the FDA, then discontinued (9)
These peptides were FDA-approved drugs but are no longer marketed as approved products in the United States. This is a meaningfully different status from never having been approved — sermorelin is the most commonly confused example.
| Peptide | Former brand(s) | Originally approved |
|---|---|---|
| Albiglutide | TANZEUM | Apr 2014 |
| BLA125431 | ||
| Enfuvirtide | FUZEON | Mar 2003 |
| NDA021481 | ||
| Gonadorelin | FACTREL, LUTREPULSE KIT | Sep 1982 |
| NDA018123, NDA019687 | ||
| Lypressin | DIAPID | — |
| NDA016755 | ||
| Macimorelin | MACRILEN | Dec 2017 |
| Approved for: MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency ( 1 ).…NDA205598 | ||
| Nesiritide | NATRECOR | Aug 2001 |
| NDA020920 | ||
| Pramlintide Boxed warning | SYMLIN | Mar 2005 |
| Approved for: SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.…NDA021332 | ||
| Protirelin | THYPINONE, THYREL TRH | Nov 1976 |
| NDA017638, NDA018087 | ||
| Sermorelin | GEREF | Dec 1990 |
| NDA019863, NDA020443 | ||
Peptides with no FDA approval (74)
These peptides have no record in Drugs@FDA — they have never been approved by the FDA as drugs for human use. Most are sold as “research chemicals” and cannot lawfully be marketed for human consumption in the United States.
Important distinction: “Not FDA-approved” does not mean “controlled substance,” and it does not mean unapproved everywhere. Carbetocin and anamorelin, for example, appear below because the FDA has not approved them, yet both are approved medicines in other countries. See our country-by-country law database for how each jurisdiction treats them.
Of these 74 peptides, 46 have at least one study registered on ClinicalTrials.gov and 32 have a study that is currently active or recruiting. A registered study is not approval, and most never lead to one, but it does show which compounds are under formal investigation rather than sold purely as research chemicals.
| Peptide | Studies | Active | Furthest phase |
|---|---|---|---|
| Somatostatin | 363 | 5 | Phase 4 |
| Leptin | 261 | 3 | Phase 4 |
| Substance-P | 151 | 3 | Phase 4 |
| Carbetocin | 103 | 3 | Phase 4 |
| Bradykinin | 73 | 4 | Phase 4 |
| Thymosin-Alpha-1 | 66 | 7 | Phase 4 |
| Cagrilintide | 44 | 10 | Phase 3 |
| Mazdutide | 44 | 10 | Phase 4 |
| Cerebrolysin | 43 | 6 | Phase 4 |
| Buserelin | 42 | 3 | Phase 4 |
| Kisspeptin | 36 | 3 | Phase 3 |
| Retatrutide | 33 | 7 | Phase 3 |
| Survodutide | 29 | 7 | Phase 3 |
| Larazotide | 29 | 2 | Phase 3 |
| Ll-37 | 20 | 2 | Phase 3 |
| Vasoactive-Intestinal-Peptide | 20 | 2 | Phase 4 |
| Thymosin-Beta-4 | 18 | 3 | Phase 3 |
| Ecnoglutide | 15 | 7 | Phase 3 |
| Tesofensine | 13 | — | Phase 2 |
| Anamorelin | 11 | 2 | Phase 3 |
| Thymopentin | 10 | — | Phase 3 |
| Ibutamoren | 8 | 1 | Phase 3 |
| Mk-677 | 8 | 1 | Phase 3 |
| Acetyl-Hexapeptide-8 | 7 | — | Phase 3 |
| Mots-C | 5 | 4 | Phase 2 |
| Efpeglenatide | 5 | — | Phase 3 |
| Ghk | 4 | 3 | Phase 4 |
| Ghk-Cu | 4 | 3 | Phase 4 |
| Bpc-157 | 4 | 2 | Phase 2 |
| Ara-290 | 4 | — | Phase 2 |
| Cibinetide | 4 | — | Phase 2 |
| Beinaglutide | 3 | 1 | Phase 4 |
| Humanin | 3 | 1 | — |
| Ipamorelin | 3 | 1 | Phase 2 |
| Pt-141 | 3 | — | Phase 3 |
| Copper-Tripeptide-1 | 2 | 1 | Phase 2 |
| Felypressin | 2 | — | Phase 4 |
| Selank | 2 | — | — |
| Epithalon | 1 | 1 | Early Phase 1 |
| Melanotan-Ii | 1 | 1 | Phase 2 |
| Tb-500 | 1 | 1 | Phase 2 |
| Cjc-1295 | 1 | — | Phase 2 |
| Ghrp-1 | 1 | — | Phase 2 |
| Palmitoyl-Tetrapeptide-7 | 1 | — | Phase 4 |
| Palmitoyl-Tripeptide-1 | 1 | — | — |
| Taltirelin | 1 | — | Phase 4 |
| 5-Amino-1MQ | none | — | — |
| Alexamorelin | none | — | — |
| Aod-9604 | none | — | — |
| Capromorelin | none | — | — |
| Cortexin | none | — | — |
| Dihexa | none | — | — |
| Examorelin | none | — | — |
| Foxo4-Dri | none | — | — |
| Fragment-176-191 | none | — | — |
| Ghrp-2 | none | — | — |
| Ghrp-6 | none | — | — |
| Hexapeptide-11 | none | — | — |
| Hexarelin | none | — | — |
| Kpv | none | — | — |
| Melanotan-I | none | — | — |
| N-Acetyl-Selank | none | — | — |
| N-Acetyl-Semax | none | — | — |
| Nonapeptide-1 | none | — | — |
| Noopept | none | — | — |
| Palmitoyl-Hexapeptide-12 | none | — | — |
| Palmitoyl-Pentapeptide-4 | none | — | — |
| Pentapeptide-18 | none | — | — |
| Pralmorelin | none | — | — |
| Semax | none | — | — |
| Snap-8 | none | — | — |
| Tabimorelin | none | — | — |
| Thymalin | none | — | — |
| Thymogen | none | — | — |
Study counts come from ClinicalTrials.gov, searched by intervention, so a listed study administers the compound rather than merely mentioning it. Counts include studies run outside the United States.
What FDA approval actually means for a peptide
FDA approval is a marketing authorization for a specific drug product, made by a specific sponsor, for a specific indication. A peptide is not approved “in general” — the approval attaches to a product such as Ozempic (semaglutide) or Egrifta (tesamorelin), which is why the table above lists brand names and application numbers rather than just the molecule.
That distinction drives three practical consequences:
- Approved peptides can be prescribed and dispensed as the approved product, and compounded only within the limits of sections 503A and 503B.
- Discontinued peptides no longer have a marketed approved product, so there is often no legal commercial source even though an approval once existed.
- Never-approved peptides cannot be lawfully marketed or sold for human use, which is the basis for most FDA warning letters in this space.
Frequently asked questions
Which peptides are FDA-approved?
Of 139 peptides tracked on this site, 56 are currently FDA-approved prescription drugs, 9 were approved by the FDA but have since been discontinued or withdrawn, and 74 have no FDA approval at all. Widely sold research peptides including BPC-157, TB-500, and CJC-1295 fall in that last group: they have never been approved by the FDA for human use.
Is BPC-157 FDA-approved?
No. BPC-157 has no record in the FDA's Drugs@FDA database, meaning it has never been approved by the FDA as a drug for human use, and it is sold as a research chemical rather than an approved medicine. It is, however, under formal investigation: 4 studies are registered on ClinicalTrials.gov, 2 of them currently active or recruiting.
Is sermorelin FDA-approved?
Sermorelin was FDA-approved as Geref (NDA019863) in 1990, but it has since been discontinued and is no longer marketed as an FDA-approved product in the United States. That makes it different from peptides like BPC-157, which were never approved at all.
Does "not FDA-approved" mean a peptide is illegal?
No. Lacking FDA approval means a peptide cannot lawfully be marketed or sold as a drug for human use in the United States, but it is not the same as being a controlled substance, and it does not mean the peptide is unapproved everywhere. Carbetocin and anamorelin, for example, have no FDA approval but are approved in other countries.
How is this list verified?
Every peptide on this page is checked directly against the FDA's Drugs@FDA database by active-ingredient name, which includes withdrawn and discontinued products, and the list was last refreshed on November 2, 2026.
Important: Approval status changes as the FDA approves new drugs and sponsors withdraw others. This page refreshes automatically from Drugs@FDA, but the FDA database is the authoritative record. This page is informational and is not legal or medical advice.