Are Peptides Legal in the United States? FDA Status
U.S. Food and Drug Administration (FDA). A neutral, source-grounded reference to how the peptides tracked on Peptide Science Daily are classified. Not legal or medical advice.
Quick answer
Of the 56 peptides tracked by Peptide Science Daily, 19 are approved medicines in the United States, 13 are prescription only or otherwise restricted, 9 are investigational (in clinical trials, not approved), and 15 have an unclear or unlisted status. A peptide is a legal medicine in the United States only where it holds approval or authorisation for use there; the rest are not approved medicines.
How the United States regulates peptides
In the United States, peptide medicines are regulated as drugs by the U.S. Food and Drug Administration (FDA). A peptide is a legal medicine only once the FDA has approved it for a specific use, at which point it is a prescription drug supplied under medical supervision.
Peptides the FDA has not approved cannot be lawfully marketed for human use, and many are sold only as laboratory research chemicals labeled "not for human consumption." Access through compounding pharmacies is also limited: the FDA restricts which bulk substances may be compounded, and several peptides have been flagged for further safety review before they can be routinely compounded.
The status shown for each compound below reflects its recorded FDA standing. Open any profile for the specific, cited regulatory sources.
Status in the United States (FDA) by compound
Every tracked peptide and its recorded status in this jurisdiction. The colored dot shows the regulatory tone; the text states the specific status. Select a compound for its full profile and cited sources.
- AbaloparatideApproved
Synthetic parathyroid hormone-related protein (PTHrP 1-34) analog; osteoanabolic agent
Approved. Postmenopausal women with osteoporosis at high risk of fracture (April 2017, brand Tymlos); expanded to men with osteoporosis at high risk of fracture (December 2022).
- AfamelanotideApproved
Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH)
Approved October 2019 as Scenesse (afamelanotide) implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP); a prescription medicine administered by a physician.
- DesmopressinApproved
Synthetic vasopressin V2-receptor agonist analog (1-deamino-8-D-arginine vasopressin)
Approved. First approved in 1978 (DDAVP); labelled indications include central diabetes insipidus, hemostasis in mild hemophilia A and von Willebrand disease, primary nocturnal enuresis, and nocturia due to nocturnal polyuria (Nocdurna).
- DulaglutideApproved
Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 analogue fused to a modified human IgG4 Fc fragment)
Approved. Trulicity for type 2 diabetes (2014); an indication to reduce major adverse cardiovascular events in adults with type 2 diabetes was added in 2020.
- ElamipretideApproved
Mitochondria-targeted tetrapeptide (cardiolipin-binding Szeto-Schiller peptide)
Granted accelerated approval on September 19, 2025 as Forzinity (elamipretide HCl) to improve muscle strength in adult and paediatric patients with Barth syndrome who weigh at least 30 kg, based on an intermediate endpoint (knee-extensor muscle strength) with a confirmatory trial required. It is not approved for any other indication, and the pivotal primary mitochondrial myopathy trial (MMPOWER-3) did not meet its primary endpoint.
- ExenatideApproved
Glucagon-like peptide-1 (GLP-1) receptor agonist; synthetic exendin-4
Approved. Byetta (exenatide twice daily) for type 2 diabetes (2005), the first GLP-1 receptor agonist approved, and Bydureon (extended-release, once weekly) (2012).
- GonadorelinApproved
Synthetic gonadotropin-releasing hormone (GnRH/LHRH); decapeptide identical to endogenous GnRH; GnRH receptor agonist
Has a history of FDA approval: gonadorelin hydrochloride (Factrel) for evaluating pituitary gonadotropic function and gonadorelin acetate (Lutrepulse) for pulsatile induction of ovulation in hypothalamic amenorrhea. Several branded products have since been discontinued in the US (not for safety reasons), and gonadorelin is now commonly supplied via pharmacy compounding.
- LanreotideApproved
Long-acting synthetic somatostatin analog (cyclic octapeptide)
Approved. Acromegaly (Somatuline Depot, August 2007); gastroenteropancreatic neuroendocrine tumors, to improve progression-free survival (December 2014); carcinoid syndrome (2017).
- LinaclotideApproved
Guanylate cyclase-C (GC-C) agonist peptide (14 amino acids)
Approved. Linzess (linaclotide) for adults with irritable bowel syndrome with constipation and with chronic idiopathic constipation, August 2012.
- LiraglutideApproved
Glucagon-like peptide-1 (GLP-1) receptor agonist (acylated GLP-1 analogue)
Approved. Victoza for type 2 diabetes (2010), with a cardiovascular risk reduction indication added in 2017; Saxenda (liraglutide 3.0 mg) for chronic weight management (2014), later extended to adolescents aged 12 to 17 with obesity (2020).
- OctreotideApproved
Synthetic somatostatin analog (octapeptide); inhibitor of growth hormone and gastroenteropancreatic hormone secretion
Approved. Acromegaly, plus symptoms associated with metastatic carcinoid tumors and VIPomas (Sandostatin, 1988); a long-acting depot form (Sandostatin LAR) is also approved.
- OrforglipronApproved
Oral small-molecule (non-peptide) agonist of the glucagon-like peptide-1 (GLP-1) receptor
Approved. The FDA approved orforglipron (Foundayo) on April 1, 2026 for chronic weight management in adults with obesity, or overweight with weight-related conditions, based on the ATTAIN Phase 3 program. A type 2 diabetes indication (ACHIEVE program) is not yet approved.
- PramlintideApproved
Synthetic amylin analog (amylinomimetic)
Approved. Initial U.S. approval 2005 (Symlin, NDA 021332) as an adjunct to mealtime insulin in adults with type 1 or type 2 diabetes who have failed to achieve glycemic control despite optimal insulin therapy. The label carries a boxed warning for insulin-induced severe hypoglycemia.
- SemaglutideApproved
Glucagon-like peptide-1 (GLP-1) receptor agonist
Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025.
- SetmelanotideApproved
Melanocortin-4 receptor (MC4R) agonist
Approved. Initial U.S. approval November 2020 for chronic weight management in patients with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing. The label was later extended to Bardet-Biedl syndrome (2022), to children as young as 2 years (2024), and to acquired hypothalamic obesity in patients 4 years and older (2026).
- TeduglutideApproved
Recombinant glucagon-like peptide-2 (GLP-2) analog
Approved. Gattex (teduglutide) for adults with short bowel syndrome who are dependent on parenteral support, December 2012; use later extended to pediatric patients.
- TeriparatideApproved
Recombinant human parathyroid hormone fragment PTH(1-34); bone-forming (anabolic) osteoporosis agent
Approved as Forteo (NDA 021318) on 26 November 2002, the first anabolic osteoporosis agent, for postmenopausal women and men at high fracture risk and, later, glucocorticoid-induced osteoporosis.
- TesamorelinApproved
Synthetic analogue of growth hormone-releasing hormone (GHRH); approved for HIV-associated lipodystrophy
Approved. Egrifta (tesamorelin) approved in November 2010 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy; reformulated products (Egrifta SV, Egrifta WR) were subsequently approved for the same indication.
- TirzepatideApproved
Dual agonist of the GIP and GLP-1 receptors (incretin-based metabolic peptide)
Approved. Mounjaro for type 2 diabetes (May 2022); Zepbound for chronic weight management (November 2023) and for moderate-to-severe obstructive sleep apnea in adults with obesity (December 2024).
- CagrilintideInvestigational
Long-acting amylin (and calcitonin) receptor agonist / amylin analogue
Investigational; not approved as a standalone product. As part of the CagriSema combination (with semaglutide), a new drug application has been filed and an FDA decision is expected later in 2026.
- FollistatinInvestigational
Endogenous activin-binding glycoprotein; myostatin/activin antagonist (studied as recombinant protein and via gene therapy, e.g., FS-344)
Not approved for any indication; follistatin-based gene therapies have been studied only in early-phase clinical trials.
- GHRP-2Investigational
Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP)
Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product.
- GHRP-6Investigational
Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; first-described growth hormone-releasing hexapeptide (His-D-Trp-Ala-Trp-D-Phe-Lys)
Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product.
- HexarelinInvestigational
Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) hexapeptide
Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product.
- KisspeptinInvestigational
Reproductive neuropeptide; KISS1 gene product and endogenous agonist of the kisspeptin receptor (KISS1R/GPR54); upstream stimulator of GnRH neurons
Not approved for any indication; investigational and studied only in clinical research.
- MazdutideInvestigational
Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors; a synthetic oxyntomodulin analogue
Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly).
- RetatrutideInvestigational
Triple agonist of the GIP, GLP-1, and glucagon receptors (investigational incretin/metabolic peptide)
Investigational; not approved. Phase 3 TRIUMPH program ongoing, with a first positive topline readout (TRIUMPH-4) reported in December 2025.
- SurvodutideInvestigational
Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors (investigational metabolic peptide)
Investigational; not approved. Being evaluated in a Phase 3 program (SYNCHRONIZE) for obesity, with additional trials in MASH.
- AOD-9604Restricted / Rx-only
Modified C-terminal fragment of human growth hormone (tyrosine-modified hGH 176-191); lipolytic peptide
Not approved as a drug; no New Drug Application and no approval for any indication. It holds self-affirmed GRAS (Generally Recognized As Safe) status as a food/dietary-supplement ingredient (a safety designation only, not an efficacy or drug approval). In 2024-2026 FDA compounding actions it was treated as a Category 2 substance, i.e. not eligible for 503A pharmacy compounding.
- BPC-157Restricted / Rx-only
Synthetic stable gastric pentadecapeptide (15-amino-acid partial sequence derived from a protein in human gastric juice)
Not FDA-approved; barred from pharmacy compounding as a 503A Category 2 bulk drug substance (2023); no approved human indication.
- CJC-1295Restricted / Rx-only
Growth hormone-releasing hormone (GHRH) analog
Not approved for any indication and never marketed. FDA placed CJC-1295 in Category 2 (potential significant safety risk) of the interim 503A bulk drug substances list; the nomination was later withdrawn/removed and the Pharmacy Compounding Advisory Committee did not recommend it for the 503A bulks list.
- EpithalonRestricted / Rx-only
Synthetic pineal tetrapeptide bioregulator (Ala-Glu-Asp-Gly / AEDG); studied as a telomerase-related peptide
Not FDA-approved for any indication. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (substances with significant safety concerns) restricting pharmacy compounding; subject of ongoing FDA compounding review in 2026.
- GHK-CuRestricted / Rx-only
Copper-binding tripeptide (glycyl-L-histidyl-L-lysine complexed with Cu2+); endogenous matrikine; cosmetic ingredient name Copper Tripeptide-1
Not an approved drug; topical form regulated as a cosmetic ingredient (Copper Tripeptide-1); injectable GHK-Cu was on the 503A Category 2 list (2023) and removed in April 2026 after nominations were withdrawn.
- IGF-1 LR3Restricted / Rx-only
Long-acting insulin-like growth factor-1 analogue (Long R3 IGF-1); recombinant IGF-1 with an Arg3 substitution and a 13-amino-acid N-terminal extension; sold as a laboratory research reagent
Not approved for any human use; marketed as a research-use-only reagent, not for human administration. It is a distinct molecule from the approved recombinant human IGF-1 drug mecasermin (Increlex).
- IpamorelinRestricted / Rx-only
Growth hormone secretagogue; ghrelin (GHS-R1a) receptor agonist (pentapeptide)
Not approved for any indication. FDA removed ipamorelin acetate from Category 2 of the interim 503A bulks list (September 2024) after the nomination was withdrawn and did not add it to the compoundable 503A list; PCAC review did not support inclusion.
- KPVRestricted / Rx-only
Tripeptide (Lys-Pro-Val); C-terminal fragment of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-derived anti-inflammatory peptide
Not FDA-approved; was on the 503A Category 2 list, removed April 2026, and scheduled for Pharmacy Compounding Advisory Committee review (July 2026).
- LixisenatideRestricted / Rx-only
Short-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-4 based incretin mimetic)
Approved as Adlyxin (NDA 208471) in July 2016 for adults with type 2 diabetes. Sanofi discontinued US sales and the standalone product was withdrawn from the US market in early 2023 for commercial reasons, not safety. The fixed-ratio insulin glargine combination Soliqua remains marketed.
- Melanotan IIRestricted / Rx-only
Synthetic cyclic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); non-selective melanocortin receptor agonist
Not approved for any use; the FDA treats melanotan II as an unapproved new drug that is marketed illegally, including as an injectable tanning product.
- PT-141 (Bremelanotide)Restricted / Rx-only
Melanocortin receptor agonist; synthetic cyclic analog of alpha-melanocyte-stimulating hormone (alpha-MSH)
Approved June 21, 2019 as Vyleesi (bremelanotide) for acquired, generalized HSDD in premenopausal women; prescription medicine.
- SemaxRestricted / Rx-only
Synthetic ACTH(4-10) analog (heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro); nootropic/neuroprotective neuropeptide
Not FDA-approved; unscheduled. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (significant safety concerns) restricting compounding; part of ongoing 2026 FDA compounding review.
- TB-500Restricted / Rx-only
Synthetic peptide fragment (Ac-LKKTETQ) corresponding to the actin-binding region of thymosin beta-4; note it is NOT the same molecule as full-length recombinant thymosin beta-4
Not FDA-approved; TB-500 placed on the 503A Category 2 list (barred from compounding). Full-length thymosin beta-4 (RGN-259) is a separate investigational drug in Phase 3 ophthalmic trials.
- AmycretinUnclear
Unimolecular GLP-1 and amylin receptor co-agonist
Not approved. Investigational only; in early-to-mid phase clinical development for obesity and not authorized for any indication.
- ArgirelineUnclear
Topical cosmetic peptide (Acetyl Hexapeptide-8); SNAP-25 N-terminal fragment mimetic
Not an FDA-approved drug. Marketed as a topical cosmetic ingredient (INCI: Acetyl Hexapeptide-8); cosmetic ingredients are not subject to FDA pre-market approval, and no therapeutic (drug) claims are authorised.
- DihexaUnclear
Angiotensin IV-derived peptide (metabolically stabilised); investigational nootropic / HGF-Met modulator
Not FDA-approved; an experimental nootropic peptide with no approved therapeutic use.
- DSIPUnclear
Delta sleep-inducing peptide; endogenous neuromodulatory nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu)
Not FDA-approved; an experimental peptide with no approved therapeutic use.
- EfpeglenatideUnclear
Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-based, once-weekly)
Not approved. Efpeglenatide remains an investigational agent with no FDA marketing authorization.
- FOXO4-DRIUnclear
Senolytic peptide (FOXO4 D-retro-inverso peptide); disrupts the FOXO4-p53 interaction
Not FDA-approved; an experimental senolytic peptide with no approved therapeutic use, and preclinical only.
- HumaninUnclear
Mitochondrial-derived peptide (24-residue; encoded in the mtDNA 16S rRNA region); cytoprotective
Not FDA-approved; a research/experimental peptide with no approved therapeutic use.
- LL-37Unclear
Human cathelicidin antimicrobial peptide (37-residue C-terminal fragment of hCAP18); host-defence peptide
Not FDA-approved; an endogenous human peptide studied in early-stage research and not an approved drug.
- Maridebart cafraglutideUnclear
Peptide-antibody conjugate with GLP-1 receptor agonist and GIP receptor antagonist activity
Not approved. Investigational only; in clinical development for obesity and type 2 diabetes and not authorized for any indication.
- MOTS-cUnclear
Mitochondrial-derived peptide (MDP); AMPK activator / exercise mimetic
Not approved for any indication; an experimental peptide with no FDA-approved therapeutic use, and not an approved/compoundable drug substance.
- PetrelintideUnclear
Long-acting amylin (islet amyloid polypeptide) receptor agonist for weight management
Not approved. Investigational and in clinical development for chronic weight management.
- SelankUnclear
Synthetic tuftsin analog (heptapeptide, Thr-Lys-Pro-Arg-Pro-Gly-Pro); anxiolytic/nootropic neuropeptide
Not FDA-approved. Selank acetate was removed from the FDA 503A 'Category 2' bulk drug substances list on September 20, 2024 after the nomination was withdrawn; it is not part of the ongoing 2026 FDA compounding review.
- SermorelinUnclear
Synthetic analogue of growth hormone-releasing hormone comprising its first 29 amino acids (GHRH 1-29); formerly FDA-approved (Geref), later withdrawn from the US market
Previously approved as Geref (sermorelin acetate) for the diagnosis and treatment of growth hormone deficiency; the product was discontinued and withdrawn from the US market around 2008 for commercial reasons, not because of safety or efficacy concerns. No FDA-approved sermorelin product is currently marketed; it is available in the US only through pharmacy compounding.
- ThymalinUnclear
Thymic polypeptide preparation (calf-thymus extract); immunomodulatory bioregulator
Not FDA-approved; no US marketing approval and not an approved medicine.
- Thymosin Alpha-1Unclear
Synthetic 28-amino-acid thymic peptide (thymalfasin); immunomodulator
Not FDA-approved for any indication; remains investigational in the United States despite approval in many other countries, and has been the subject of US clinical study and orphan-drug interest without a marketing approval.
| Compound | Tone | Status in the United States (FDA) |
|---|---|---|
| Abaloparatide Synthetic parathyroid hormone-related protein (PTHrP 1-34) analog; osteoanabolic agent | Approved | Approved. Postmenopausal women with osteoporosis at high risk of fracture (April 2017, brand Tymlos); expanded to men with osteoporosis at high risk of fracture (December 2022). |
| Afamelanotide Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH) | Approved | Approved October 2019 as Scenesse (afamelanotide) implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP); a prescription medicine administered by a physician. |
| Desmopressin Synthetic vasopressin V2-receptor agonist analog (1-deamino-8-D-arginine vasopressin) | Approved | Approved. First approved in 1978 (DDAVP); labelled indications include central diabetes insipidus, hemostasis in mild hemophilia A and von Willebrand disease, primary nocturnal enuresis, and nocturia due to nocturnal polyuria (Nocdurna). |
| Dulaglutide Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 analogue fused to a modified human IgG4 Fc fragment) | Approved | Approved. Trulicity for type 2 diabetes (2014); an indication to reduce major adverse cardiovascular events in adults with type 2 diabetes was added in 2020. |
| Elamipretide Mitochondria-targeted tetrapeptide (cardiolipin-binding Szeto-Schiller peptide) | Approved | Granted accelerated approval on September 19, 2025 as Forzinity (elamipretide HCl) to improve muscle strength in adult and paediatric patients with Barth syndrome who weigh at least 30 kg, based on an intermediate endpoint (knee-extensor muscle strength) with a confirmatory trial required. It is not approved for any other indication, and the pivotal primary mitochondrial myopathy trial (MMPOWER-3) did not meet its primary endpoint. |
| Exenatide Glucagon-like peptide-1 (GLP-1) receptor agonist; synthetic exendin-4 | Approved | Approved. Byetta (exenatide twice daily) for type 2 diabetes (2005), the first GLP-1 receptor agonist approved, and Bydureon (extended-release, once weekly) (2012). |
| Gonadorelin Synthetic gonadotropin-releasing hormone (GnRH/LHRH); decapeptide identical to endogenous GnRH; GnRH receptor agonist | Approved | Has a history of FDA approval: gonadorelin hydrochloride (Factrel) for evaluating pituitary gonadotropic function and gonadorelin acetate (Lutrepulse) for pulsatile induction of ovulation in hypothalamic amenorrhea. Several branded products have since been discontinued in the US (not for safety reasons), and gonadorelin is now commonly supplied via pharmacy compounding. |
| Lanreotide Long-acting synthetic somatostatin analog (cyclic octapeptide) | Approved | Approved. Acromegaly (Somatuline Depot, August 2007); gastroenteropancreatic neuroendocrine tumors, to improve progression-free survival (December 2014); carcinoid syndrome (2017). |
| Linaclotide Guanylate cyclase-C (GC-C) agonist peptide (14 amino acids) | Approved | Approved. Linzess (linaclotide) for adults with irritable bowel syndrome with constipation and with chronic idiopathic constipation, August 2012. |
| Liraglutide Glucagon-like peptide-1 (GLP-1) receptor agonist (acylated GLP-1 analogue) | Approved | Approved. Victoza for type 2 diabetes (2010), with a cardiovascular risk reduction indication added in 2017; Saxenda (liraglutide 3.0 mg) for chronic weight management (2014), later extended to adolescents aged 12 to 17 with obesity (2020). |
| Octreotide Synthetic somatostatin analog (octapeptide); inhibitor of growth hormone and gastroenteropancreatic hormone secretion | Approved | Approved. Acromegaly, plus symptoms associated with metastatic carcinoid tumors and VIPomas (Sandostatin, 1988); a long-acting depot form (Sandostatin LAR) is also approved. |
| Orforglipron Oral small-molecule (non-peptide) agonist of the glucagon-like peptide-1 (GLP-1) receptor | Approved | Approved. The FDA approved orforglipron (Foundayo) on April 1, 2026 for chronic weight management in adults with obesity, or overweight with weight-related conditions, based on the ATTAIN Phase 3 program. A type 2 diabetes indication (ACHIEVE program) is not yet approved. |
| Pramlintide Synthetic amylin analog (amylinomimetic) | Approved | Approved. Initial U.S. approval 2005 (Symlin, NDA 021332) as an adjunct to mealtime insulin in adults with type 1 or type 2 diabetes who have failed to achieve glycemic control despite optimal insulin therapy. The label carries a boxed warning for insulin-induced severe hypoglycemia. |
| Semaglutide Glucagon-like peptide-1 (GLP-1) receptor agonist | Approved | Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025. |
| Setmelanotide Melanocortin-4 receptor (MC4R) agonist | Approved | Approved. Initial U.S. approval November 2020 for chronic weight management in patients with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing. The label was later extended to Bardet-Biedl syndrome (2022), to children as young as 2 years (2024), and to acquired hypothalamic obesity in patients 4 years and older (2026). |
| Teduglutide Recombinant glucagon-like peptide-2 (GLP-2) analog | Approved | Approved. Gattex (teduglutide) for adults with short bowel syndrome who are dependent on parenteral support, December 2012; use later extended to pediatric patients. |
| Teriparatide Recombinant human parathyroid hormone fragment PTH(1-34); bone-forming (anabolic) osteoporosis agent | Approved | Approved as Forteo (NDA 021318) on 26 November 2002, the first anabolic osteoporosis agent, for postmenopausal women and men at high fracture risk and, later, glucocorticoid-induced osteoporosis. |
| Tesamorelin Synthetic analogue of growth hormone-releasing hormone (GHRH); approved for HIV-associated lipodystrophy | Approved | Approved. Egrifta (tesamorelin) approved in November 2010 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy; reformulated products (Egrifta SV, Egrifta WR) were subsequently approved for the same indication. |
| Tirzepatide Dual agonist of the GIP and GLP-1 receptors (incretin-based metabolic peptide) | Approved | Approved. Mounjaro for type 2 diabetes (May 2022); Zepbound for chronic weight management (November 2023) and for moderate-to-severe obstructive sleep apnea in adults with obesity (December 2024). |
| Cagrilintide Long-acting amylin (and calcitonin) receptor agonist / amylin analogue | Investigational | Investigational; not approved as a standalone product. As part of the CagriSema combination (with semaglutide), a new drug application has been filed and an FDA decision is expected later in 2026. |
| Follistatin Endogenous activin-binding glycoprotein; myostatin/activin antagonist (studied as recombinant protein and via gene therapy, e.g., FS-344) | Investigational | Not approved for any indication; follistatin-based gene therapies have been studied only in early-phase clinical trials. |
| GHRP-2 Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) | Investigational | Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product. |
| GHRP-6 Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; first-described growth hormone-releasing hexapeptide (His-D-Trp-Ala-Trp-D-Phe-Lys) | Investigational | Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product. |
| Hexarelin Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) hexapeptide | Investigational | Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product. |
| Kisspeptin Reproductive neuropeptide; KISS1 gene product and endogenous agonist of the kisspeptin receptor (KISS1R/GPR54); upstream stimulator of GnRH neurons | Investigational | Not approved for any indication; investigational and studied only in clinical research. |
| Mazdutide Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors; a synthetic oxyntomodulin analogue | Investigational | Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly). |
| Retatrutide Triple agonist of the GIP, GLP-1, and glucagon receptors (investigational incretin/metabolic peptide) | Investigational | Investigational; not approved. Phase 3 TRIUMPH program ongoing, with a first positive topline readout (TRIUMPH-4) reported in December 2025. |
| Survodutide Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors (investigational metabolic peptide) | Investigational | Investigational; not approved. Being evaluated in a Phase 3 program (SYNCHRONIZE) for obesity, with additional trials in MASH. |
| AOD-9604 Modified C-terminal fragment of human growth hormone (tyrosine-modified hGH 176-191); lipolytic peptide | Restricted / Rx-only | Not approved as a drug; no New Drug Application and no approval for any indication. It holds self-affirmed GRAS (Generally Recognized As Safe) status as a food/dietary-supplement ingredient (a safety designation only, not an efficacy or drug approval). In 2024-2026 FDA compounding actions it was treated as a Category 2 substance, i.e. not eligible for 503A pharmacy compounding. |
| BPC-157 Synthetic stable gastric pentadecapeptide (15-amino-acid partial sequence derived from a protein in human gastric juice) | Restricted / Rx-only | Not FDA-approved; barred from pharmacy compounding as a 503A Category 2 bulk drug substance (2023); no approved human indication. |
| CJC-1295 Growth hormone-releasing hormone (GHRH) analog | Restricted / Rx-only | Not approved for any indication and never marketed. FDA placed CJC-1295 in Category 2 (potential significant safety risk) of the interim 503A bulk drug substances list; the nomination was later withdrawn/removed and the Pharmacy Compounding Advisory Committee did not recommend it for the 503A bulks list. |
| Epithalon Synthetic pineal tetrapeptide bioregulator (Ala-Glu-Asp-Gly / AEDG); studied as a telomerase-related peptide | Restricted / Rx-only | Not FDA-approved for any indication. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (substances with significant safety concerns) restricting pharmacy compounding; subject of ongoing FDA compounding review in 2026. |
| GHK-Cu Copper-binding tripeptide (glycyl-L-histidyl-L-lysine complexed with Cu2+); endogenous matrikine; cosmetic ingredient name Copper Tripeptide-1 | Restricted / Rx-only | Not an approved drug; topical form regulated as a cosmetic ingredient (Copper Tripeptide-1); injectable GHK-Cu was on the 503A Category 2 list (2023) and removed in April 2026 after nominations were withdrawn. |
| IGF-1 LR3 Long-acting insulin-like growth factor-1 analogue (Long R3 IGF-1); recombinant IGF-1 with an Arg3 substitution and a 13-amino-acid N-terminal extension; sold as a laboratory research reagent | Restricted / Rx-only | Not approved for any human use; marketed as a research-use-only reagent, not for human administration. It is a distinct molecule from the approved recombinant human IGF-1 drug mecasermin (Increlex). |
| Ipamorelin Growth hormone secretagogue; ghrelin (GHS-R1a) receptor agonist (pentapeptide) | Restricted / Rx-only | Not approved for any indication. FDA removed ipamorelin acetate from Category 2 of the interim 503A bulks list (September 2024) after the nomination was withdrawn and did not add it to the compoundable 503A list; PCAC review did not support inclusion. |
| KPV Tripeptide (Lys-Pro-Val); C-terminal fragment of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-derived anti-inflammatory peptide | Restricted / Rx-only | Not FDA-approved; was on the 503A Category 2 list, removed April 2026, and scheduled for Pharmacy Compounding Advisory Committee review (July 2026). |
| Lixisenatide Short-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-4 based incretin mimetic) | Restricted / Rx-only | Approved as Adlyxin (NDA 208471) in July 2016 for adults with type 2 diabetes. Sanofi discontinued US sales and the standalone product was withdrawn from the US market in early 2023 for commercial reasons, not safety. The fixed-ratio insulin glargine combination Soliqua remains marketed. |
| Melanotan II Synthetic cyclic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); non-selective melanocortin receptor agonist | Restricted / Rx-only | Not approved for any use; the FDA treats melanotan II as an unapproved new drug that is marketed illegally, including as an injectable tanning product. |
| PT-141 (Bremelanotide) Melanocortin receptor agonist; synthetic cyclic analog of alpha-melanocyte-stimulating hormone (alpha-MSH) | Restricted / Rx-only | Approved June 21, 2019 as Vyleesi (bremelanotide) for acquired, generalized HSDD in premenopausal women; prescription medicine. |
| Semax Synthetic ACTH(4-10) analog (heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro); nootropic/neuroprotective neuropeptide | Restricted / Rx-only | Not FDA-approved; unscheduled. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (significant safety concerns) restricting compounding; part of ongoing 2026 FDA compounding review. |
| TB-500 Synthetic peptide fragment (Ac-LKKTETQ) corresponding to the actin-binding region of thymosin beta-4; note it is NOT the same molecule as full-length recombinant thymosin beta-4 | Restricted / Rx-only | Not FDA-approved; TB-500 placed on the 503A Category 2 list (barred from compounding). Full-length thymosin beta-4 (RGN-259) is a separate investigational drug in Phase 3 ophthalmic trials. |
| Amycretin Unimolecular GLP-1 and amylin receptor co-agonist | Unclear | Not approved. Investigational only; in early-to-mid phase clinical development for obesity and not authorized for any indication. |
| Argireline Topical cosmetic peptide (Acetyl Hexapeptide-8); SNAP-25 N-terminal fragment mimetic | Unclear | Not an FDA-approved drug. Marketed as a topical cosmetic ingredient (INCI: Acetyl Hexapeptide-8); cosmetic ingredients are not subject to FDA pre-market approval, and no therapeutic (drug) claims are authorised. |
| Dihexa Angiotensin IV-derived peptide (metabolically stabilised); investigational nootropic / HGF-Met modulator | Unclear | Not FDA-approved; an experimental nootropic peptide with no approved therapeutic use. |
| DSIP Delta sleep-inducing peptide; endogenous neuromodulatory nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu) | Unclear | Not FDA-approved; an experimental peptide with no approved therapeutic use. |
| Efpeglenatide Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-based, once-weekly) | Unclear | Not approved. Efpeglenatide remains an investigational agent with no FDA marketing authorization. |
| FOXO4-DRI Senolytic peptide (FOXO4 D-retro-inverso peptide); disrupts the FOXO4-p53 interaction | Unclear | Not FDA-approved; an experimental senolytic peptide with no approved therapeutic use, and preclinical only. |
| Humanin Mitochondrial-derived peptide (24-residue; encoded in the mtDNA 16S rRNA region); cytoprotective | Unclear | Not FDA-approved; a research/experimental peptide with no approved therapeutic use. |
| LL-37 Human cathelicidin antimicrobial peptide (37-residue C-terminal fragment of hCAP18); host-defence peptide | Unclear | Not FDA-approved; an endogenous human peptide studied in early-stage research and not an approved drug. |
| Maridebart cafraglutide Peptide-antibody conjugate with GLP-1 receptor agonist and GIP receptor antagonist activity | Unclear | Not approved. Investigational only; in clinical development for obesity and type 2 diabetes and not authorized for any indication. |
| MOTS-c Mitochondrial-derived peptide (MDP); AMPK activator / exercise mimetic | Unclear | Not approved for any indication; an experimental peptide with no FDA-approved therapeutic use, and not an approved/compoundable drug substance. |
| Petrelintide Long-acting amylin (islet amyloid polypeptide) receptor agonist for weight management | Unclear | Not approved. Investigational and in clinical development for chronic weight management. |
| Selank Synthetic tuftsin analog (heptapeptide, Thr-Lys-Pro-Arg-Pro-Gly-Pro); anxiolytic/nootropic neuropeptide | Unclear | Not FDA-approved. Selank acetate was removed from the FDA 503A 'Category 2' bulk drug substances list on September 20, 2024 after the nomination was withdrawn; it is not part of the ongoing 2026 FDA compounding review. |
| Sermorelin Synthetic analogue of growth hormone-releasing hormone comprising its first 29 amino acids (GHRH 1-29); formerly FDA-approved (Geref), later withdrawn from the US market | Unclear | Previously approved as Geref (sermorelin acetate) for the diagnosis and treatment of growth hormone deficiency; the product was discontinued and withdrawn from the US market around 2008 for commercial reasons, not because of safety or efficacy concerns. No FDA-approved sermorelin product is currently marketed; it is available in the US only through pharmacy compounding. |
| Thymalin Thymic polypeptide preparation (calf-thymus extract); immunomodulatory bioregulator | Unclear | Not FDA-approved; no US marketing approval and not an approved medicine. |
| Thymosin Alpha-1 Synthetic 28-amino-acid thymic peptide (thymalfasin); immunomodulator | Unclear | Not FDA-approved for any indication; remains investigational in the United States despite approval in many other countries, and has been the subject of US clinical study and orphan-drug interest without a marketing approval. |
Regulatory classifications change; entries reflect the status recorded in each compound profile and are provided for reference, not as legal or medical advice.
Common questions
- Are peptides legal in the United States?
- It depends on the specific peptide. A peptide is a legal medicine in the United States only where it holds approval or authorisation for use there. Of the 56 peptides tracked here, 19 are recorded as approved, 13 as prescription only or restricted, and 9 as investigational; the remaining 15 have an unclear or unlisted status. Unapproved peptides are not legal medicines.
- Which peptides are approved for use in the United States?
- The following peptides tracked here are recorded as approved or authorised in the United States: Abaloparatide, Afamelanotide, Desmopressin, Dulaglutide, Elamipretide, Exenatide, Gonadorelin, Lanreotide, Linaclotide, Liraglutide, Octreotide, Orforglipron, Pramlintide, Semaglutide, Setmelanotide, Teduglutide, Teriparatide, Tesamorelin, Tirzepatide. Any tracked peptide not listed here does not have a recorded status of approved in the United States.