Regulatory Compliance Database

U.S. FDA regulatory classification reference for peptides and related compounds. Understand legal status, compounding eligibility, and compliance requirements.

FDA-Approved
Investigational
Research Only
Cosmetic
Supplement
45Showing
45Total
7FDA-Approved
Compound Category Brands Status & Notes 503A
Semaglutide
GLP-1 Agonist
FDA-ApprovedOzempic, WegovyApproved for T2D (2017) and weight management. Orange Book listed. Rx required.✓ Yes
Tirzepatide
GIP/GLP-1 Agonist
FDA-ApprovedMounjaro, ZepboundApproved May 2022 T2D, Nov 2023 obesity. First dual-incretin therapy.✓ Yes
Bremelanotide
PT-141
FDA-ApprovedVyleesiApproved 2019 for HSDD in premenopausal women.✗ No
Tesamorelin
GHRH Analog
FDA-ApprovedEgriftaApproved 2010 for HIV lipodystrophy.✓ Yes
Oxytocin
Hormone
FDA-ApprovedPitocinApproved for labor induction and postpartum bleeding.✓ Yes
Sermorelin
GHRH Analog
FDA-ApprovedGeref (disc.)Approved 1997 childhood GHD. NDA discontinued but was approved.✓ Yes
IGF-1
Mecasermin
FDA-ApprovedIncrelexApproved for growth failure in children with IGF-1 deficiency.✗ No
Retatrutide
Triple Agonist
InvestigationalNone (Lilly)Phase 3 for obesity/diabetes. Not approved. Clinical trials only.✗ No
Mazdutide
GLP-1/Glucagon
InvestigationalNoneNot FDA-approved. NMPA China 2025. Phase 3 in U.S.✗ No
Survodutide
GLP-1/Glucagon
InvestigationalNone (Boehringer)Phase 2/3 for obesity and NASH. ~19% weight loss Phase 2.✗ No
Cagrilintide
Amylin Analog
InvestigationalNone (Novo)Investigational for obesity. CagriSema combo in Phase 3.✗ No
SS-31
Elamipretide
InvestigationalNoneMitochondria-targeted peptide. Phase 2/3 heart failure.✗ No
BPC-157
Body Protection Compound
🔬 Research OnlyNoneNOT approved. FDA/DoD classify as unapproved drug. Prohibited military supplements.✗ No
Epitalon
Pineal Tetrapeptide
🔬 Research OnlyNoneNot approved. No 503A listing. Lab use only.✗ No
TB-500
Thymosin Beta-4 Frag
🔬 Research OnlyNoneNot approved. Research purposes only.✗ No
CJC-1295
GHRH Analog
🔬 Research OnlyNoneNot approved. 503A nomination withdrawn.⏳ Review
Ipamorelin
GHRP
🔬 Research OnlyNoneNot approved. 503A nomination withdrawn.⏳ Review
Selank
Heptapeptide
🔬 Research OnlyNoneRussian anxiolytic. Not FDA-approved. Category 2 removed 2024.✗ No
Semax
ACTH Fragment
🔬 Research OnlyNoneRussian nootropic. Not U.S. approved. Research only.✗ No
LL-37
Cathelicidin
🔬 Research OnlyNoneFDA flagged 2020. Not permissible for compounding.✗ No
DSIP
Delta Sleep Peptide
🔬 Research OnlyNoneFDA 2020 banned from compounding. No approval.✗ No
Follistatin-344
Myostatin Inhibitor
🔬 Research OnlyNoneNo FDA use. Biologic regulations apply. Research only.✗ No
FOXO4-DRI
Senolytic
🔬 Research OnlyNoneExperimental anti-aging. Mouse studies only. Lab reagent.✗ No
Dihexa
Neuropeptide
🔬 Research OnlyNoneNot approved. Experimental neurotrophic. Research only.✗ No
Melanotan II
Tanning Peptide
🔬 Research OnlyNoneNot approved for tanning. Gray-market. FDA warning issued.✗ No
Thymosin Alpha-1
Ta1
🔬 Research OnlyZadaxin (non-US)Not U.S. approved. 503A under review.⏳ Review
AOD-9604
HGH Fragment
🔬 Research OnlyNoneNot approved. Modified GH fragment. Research only.✗ No
GHK (Injectable)
Tripeptide
🔬 Research OnlyNoneInjectable not approved. Topical GHK-Cu is cosmetic.✗ No
Kisspeptin
KISS1
🔬 Research OnlyNoneInvestigational fertility applications. Research only.✗ No
MOTS-c
Mitochondrial Peptide
🔬 Research OnlyNoneMetabolic research. No approved human uses.✗ No
ARA-290
Cibinetide
🔬 Research OnlyNoneHad orphan status, no approval. Phase 2 conducted.✗ No
GHK-Cu
Copper Tripeptide
💄 CosmeticVarious serumsTopical anti-aging cosmetic. Injectable NOT approved.✗ No
SNAP-8
Acetyl Octapeptide
💄 CosmeticWrinkle creamsCosmetic ingredient. No drug approval. Topical only.✗ No
Argireline
Acetyl Hexapeptide
💄 CosmeticAnti-aging serumsCosmetic peptide. No drug claims permitted.✗ No
Matrixyl
Palmitoyl Pentapeptide
💄 CosmeticSkincareCosmetic for collagen support. No drug approval needed.✗ No
Glutathione
GSH
💊 SupplementVariousGRAS status. Tripeptide antioxidant. Widely sold as supplement.✓ Yes
NAD+
Coenzyme
💊 SupplementTru NiagenB3 derivative. NR has NDI/GRAS. Legal supplement.✓ Yes
L-Carnitine
Amino Acid
💊 SupplementVariousAccepted dietary ingredient. DSHEA grandfathered.✓ Yes
Carnosine
Dipeptide
💊 SupplementVariousFound in meat. Long supplement history. Dietary ingredient.✓ Yes
Anserine
Dipeptide
💊 SupplementVariousFood-derived (chicken/fish). DSHEA compliant.✓ Yes
L-Theanine
Tea Amino Acid
💊 SupplementVariousGRAS status. From tea. Cognitive/relaxation support.✓ Yes
Mg L-Threonate
Magtein
💊 SupplementMagteinGRAS. Mineral supplement for cognitive health.✓ Yes
Collagen Peptides
Hydrolyzed
💊 SupplementVariousGRAS. Food-derived. Skin/joint support.✓ Yes
BCAAs
Branched-Chain AA
💊 SupplementVariousEssential amino acids. DSHEA accepted.✓ Yes
Creatine
Monohydrate
💊 SupplementVariousGRAS. Most studied supplement. Athletic performance.✓ Yes

⚖️ Understanding Regulatory Categories

✓ FDA-Approved Drug

NDA-approved peptides listed in FDA Orange Book. Require prescription. Off-label use permitted under physician supervision.

⏳ Investigational (IND)

Peptides in FDA-regulated clinical trials. Not approved for commercial sale. Only accessible through clinical studies.

🔬 Research Use Only

Unapproved peptides for laboratory research only. Cannot be marketed for human use. Not eligible for 503A compounding.

💄 Cosmetic Ingredient

Permitted in topical products for appearance. No pre-approval required without drug claims. Injectable use not approved.

💊 Dietary Supplement

DSHEA-compliant ingredients: vitamins, minerals, herbs, amino acids, food constituents. GRAS or NDI status may be required.