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 137 peptides tracked on this site, 54 are currently FDA-approved prescription drugs, 9 were approved by the FDA but have since been discontinued or withdrawn, and 74 have no FDA approval at all.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.

54FDA-approved 9approved, then discontinued 74never approved

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 Each peptide is looked up by FDA active-ingredient name, which includes withdrawn and discontinued products, so a peptide shown as never approved genuinely has no FDA drug record.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 September 16, 2026.

FDA-approved peptide drugs (54)

Peptides with at least one currently marketed, FDA-approved prescription product.

FDA-approved peptide drugs, by active ingredient
Peptide	Brand name(s)	First approved	Application(s)
Abaloparatide	TYMLOS	Apr 2017	NDA208743
Afamelanotide	SCENESSE	Oct 2019	NDA210797
Angiotensin-Ii	ANGIOTENSIN ll ACETATE, GIAPREZA	Dec 2017	ANDA216966, NDA209360
Bivalirudin	ANGIOMAX, ANGIOMAX RTU, BIVALIRUDIN, BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	Dec 2000	ANDA090189, ANDA090811, ANDA090816
Bremelanotide	VYLEESI (AUTOINJECTOR)	Jun 2019	NDA210557
Calcitonin	CALCIMAR, CALCITONIN-SALMON, CIBACALCIN, FORTICAL	Apr 1978	ANDA073690, ANDA076396, ANDA076979
Cetrorelix	CETRORELIX ACETATE, CETROTIDE	Aug 2000	ANDA214540, ANDA215737, ANDA217776
Corticorelin	ACTHREL	May 1996	BLA020162
Corticotropin	ACTH, ACTHAR, ACTHAR GEL, ACTHAR GEL (AUTOINJECTOR)	Jul 1950	ANDA088772, NDA007504, NDA008317
Cosyntropin	CORTROSYN, COSYNTROPIN	Apr 1970	ANDA090574, ANDA202147, NDA016750
Degarelix	DEGARELIX ACETATE, FIRMAGON	Dec 2008	ANDA215791, NDA022201
Desmopressin	CONCENTRAID, DDAVP, DDAVP (NEEDS NO REFRIGERATION), DESMODA	Feb 1978	ANDA074574, ANDA074575, ANDA074830
Difelikefalin	DIFELIKEFALIN ACETATE, KORSUVA	Aug 2021	ANDA220919, NDA214916
Dulaglutide	TRULICITY	Sep 2014	BLA125469
Ecallantide	KALBITOR	Dec 2009	BLA125277
Elamipretide	FORZINITY	Sep 2025	NDA215244
Etelcalcetide	PARSABIV	Feb 2017	NDA208325
Exenatide	BYDUREON, BYDUREON BCISE, BYDUREON PEN, BYETTA	Apr 2005	ANDA206697, NDA021773, NDA021919
Ganirelix	FYREMADEL, GANIRELIX ACETATE	Jul 1999	ANDA204246, ANDA212613, ANDA214996
Glatiramer	COPAXONE, GLATIRAMER ACETATE, GLATOPA	Dec 1996	ANDA090218, ANDA091646, ANDA203857
Glucagon	BAQSIMI, GLUCAGEN, GLUCAGON, GVOKE HYPOPEN	Nov 1960	ANDA071022, ANDA071023, ANDA204468
Goserelin	ZOLADEX	Dec 1989	NDA019726, NDA020515, NDA020578
Histrelin	SUPPRELIN, SUPPRELIN LA, VANTAS	Dec 1991	NDA019836, NDA021732, NDA022058
Icatibant	FIRAZYR, ICATIBANT ACETATE	Aug 2011	ANDA208317, ANDA210118, ANDA211021
Insulin-Aspart	FIASP, FIASP FLEXTOUCH, FIASP PENFILL, GARZULYS	Jun 2000	BLA020986, BLA021172, BLA021810
Insulin-Degludec	RYZODEG 70/30, TRESIBA, XULTOPHY 100/3.6	Sep 2015	BLA203313, BLA203314, BLA208583
Insulin-Detemir	LEVEMIR, LEVEMIR FLEXPEN, LEVEMIR FLEXTOUCH, LEVEMIR INNOLET	Jun 2005	BLA021536, BLA021878
Insulin-Glargine	BASAGLAR, LANGLARA, LANTUS, LANTUS SOLOSTAR	Apr 2000	BLA021081, BLA205692, BLA206538
Insulin-Glulisine	APIDRA, APIDRA SOLOSTAR	Apr 2004	BLA021629
Insulin-Lispro	ADMELOG, ADMELOG SOLOSTAR, HUMALOG, HUMALOG KWIKPEN	Jun 1996	BLA020563, BLA021017, BLA021018
Lanreotide	LANREOTIDE ACETATE, SOMATULINE DEPOT	Aug 2007	ANDA217193, NDA022074, NDA215395
Leuprolide	CAMCEVI ETM, CAMCEVI KIT, ELIGARD KIT, FENSOLVI KIT	Apr 1985	ANDA074728, ANDA075471, ANDA075721
Linaclotide	LINACLOTIDE, LINZESS	Aug 2012	ANDA209564, ANDA209611, ANDA211255
Liraglutide	LIRAGLUTIDE, SAXENDA, VICTOZA, XULTOPHY 100/3.6	Jan 2010	ANDA212552, ANDA212972, ANDA213155
Lixisenatide	ADLYXIN, SOLIQUA 100/33	Jul 2016	BLA208471, BLA208673
Nafarelin	SYNAREL	Feb 1990	NDA019886
Octreotide	BYNFEZIA PEN, MYCAPSSA, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE (PRESERVATIVE FREE)	Oct 1988	ANDA075957, ANDA075959, ANDA076313
Oxytocin	OXYTOCIN, OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5%, OXYTOCIN 5 USP UNITS IN DEXTROSE 5%	Apr 1980	ANDA077453, ANDA091676, ANDA200219
Pasireotide	SIGNIFOR, SIGNIFOR LAR KIT	Dec 2012	NDA200677, NDA203255
Plecanatide	TRULANCE	Jan 2017	NDA208745
Secretin	CHIRHOSTIM, PORCINE SECRETIN, SECREFLO, SECRETIN-FERRING	Apr 2002	NDA018290, NDA021136, NDA021209
Semaglutide	OZEMPIC, RYBELSUS, SEMAGLUTIDE, WEGOVY	Dec 2017	ANDA220314, NDA209637, NDA213051
Setmelanotide	IMCIVREE	Nov 2020	NDA213793
Sincalide	KINEVAC, SINCALIDE	Jul 1976	NDA017697, NDA210850
Somatropin-Recombinant	ZORBTIVE	Dec 2003	BLA021597
Teduglutide	GATTEX KIT	Dec 2012	NDA203441
Teriparatide	BONSITY, FORTEO, PARATHAR, TERIPARATIDE	Nov 2002	ANDA208569, ANDA211097, ANDA213641
Terlipressin	TERLIVAZ	Sep 2022	NDA022231
Tesamorelin	EGRIFTA	Nov 2010	BLA022505
Tirzepatide	MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN, ZEPBOUND	May 2022	NDA215866, NDA217806
Triptorelin	TRELSTAR, TRIPTODUR KIT	Jun 2000	NDA020715, NDA021288, NDA022437
Vasopressin	PITRESSIN TANNATE, VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5%, VASOPRESSIN IN SODIUM CHLORIDE 0.9%	Apr 2014	ANDA211538, ANDA211857, ANDA212068
Vosoritide	VOXZOGO	Nov 2021	NDA214938
Ziconotide	PRIALT	Dec 2004	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.

Peptides approved by the FDA and since discontinued
Peptide	Former brand(s)	Originally approved	Application(s)
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	NDA205598
Nesiritide	NATRECOR	Aug 2001	NDA020920
Pramlintide	SYMLIN	Mar 2005	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.

5-Amino-1MQ Acetyl-Hexapeptide-8 Alexamorelin Anamorelin Aod-9604 Ara-290 Beinaglutide Bpc-157 Bradykinin Buserelin Cagrilintide Capromorelin Carbetocin Cerebrolysin Cibinetide Cjc-1295 Copper-Tripeptide-1 Cortexin Dihexa Ecnoglutide Efpeglenatide Epithalon Examorelin Felypressin Foxo4-Dri Fragment-176-191 Ghk Ghk-Cu Ghrp-1 Ghrp-2 Ghrp-6 Hexapeptide-11 Hexarelin Humanin Ibutamoren Ipamorelin Kisspeptin Kpv Larazotide Leptin Ll-37 Mazdutide Melanotan-I Melanotan-Ii Mk-677 Mots-C N-Acetyl-Selank N-Acetyl-Semax Nonapeptide-1 Noopept Palmitoyl-Hexapeptide-12 Palmitoyl-Pentapeptide-4 Palmitoyl-Tetrapeptide-7 Palmitoyl-Tripeptide-1 Pentapeptide-18 Pralmorelin Pt-141 Retatrutide Selank Semax Snap-8 Somatostatin Substance-P Survodutide Tabimorelin Taltirelin Tb-500 Tesofensine Thymalin Thymogen Thymopentin Thymosin-Alpha-1 Thymosin-Beta-4 Vasoactive-Intestinal-Peptide

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 137 peptides tracked on this site, 54 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. It is sold as a research chemical, not an approved medicine.

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 September 16, 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.