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Peptide Regulatory Tracker

FDA approval status and regulatory classification for 94 peptides. Updated as regulatory changes occur.

Peptide	Status	Category	Evidence	Notes
Glutathione GSH, L-Glutathione	FDA Approved	Longevity	Moderate	Generally Recognized as Safe (GRAS). Available as dietary supplement; IV formulations used clinically.
HMG Human Menopausal Gonadotropin, Menotropins	FDA Approved	Hormonal	High	FDA-approved (Menopur) for assisted reproduction.
Human Chorionic Gonadotropin (hCG) hCG, Choriogonadotropin	FDA Approved	Hormonal	High	FDA-approved (Pregnyl, Ovidrel) for fertility treatment.
Liraglutide Victoza, Saxenda	FDA Approved	Metabolic	High	FDA-approved as Victoza (T2D) and Saxenda (weight management).
Melanotan-1 Afamelanotide, Scenesse	FDA Approved	Other	Moderate	FDA-approved October 2019 (NDA 210797) as Scenesse for the prevention of phototoxicity in adults with EPP. EMA-approved ...
Pasireotide SOM230, Signifor	FDA Approved	Hormonal	High	FDA-approved as Signifor for Cushing's disease and acromegaly.
PT-141 Bremelanotide, Vyleesi	FDA Approved	Hormonal	High	FDA-approved as Vyleesi (bremelanotide) for hypoactive sexual desire disorder in premenopausal women.
Semaglutide Ozempic, Wegovy	FDA Approved	Metabolic	High	FDA-approved as Ozempic (T2D), Wegovy (weight management), and Rybelsus (oral T2D). Compounded versions restricted since...
Tesamorelin Egrifta, Egrifta SV	FDA Approved	Hormonal	High	FDA-approved as Egrifta for HIV-associated lipodystrophy.
Tirzepatide LY3298176, Mounjaro	FDA Approved	Metabolic	High	FDA-approved as Mounjaro (T2D) and Zepbound (weight management). Compounded versions restricted since 2024.
225Ac-DOTA-LM3 Actinium-225-DOTA-LM3, 225Ac-DOTA-JR11	Investigational	Other	Moderate	Phase 1/2 clinical trials for prostate cancer. Alpha-emitting PSMA-targeting radiopharmaceutical.
Alixorexton ALKS 2680, ALKS-2680	Investigational	Cognitive	Moderate	Phase 1 clinical trials (Novo Nordisk). Next-gen metabolic candidate.
Amycretin NNC0487-0111, Oral Amycretin	Investigational	Metabolic	Moderate	Phase 2 clinical trials for obesity (Novo Nordisk). Oral GLP-1/amylin dual agonist.
BT5528 Bicycle Toxin Conjugate 5528, EphA2-BTC	Investigational	Other	Moderate	Phase 1/2 clinical trials for solid tumors (Bicycle Therapeutics). EphA2-targeting bicycle toxin conjugate.
Cagrilintide AM833, NN9838	Investigational	Metabolic	High	Phase 3 as part of CagriSema combination (Novo Nordisk). Long-acting amylin analog.
CagriSema Cagrilintide-Semaglutide, NNC0174-0833	Investigational	Metabolic	High	Phase 3 clinical trials for obesity (Novo Nordisk). Cagrilintide + semaglutide combination.
CT-388 RG-6912	Investigational	Metabolic	Moderate	Phase 2 clinical trials for obesity (Carmot Therapeutics/Roche). GLP-1/GIP dual agonist.
EVX-01 EVX01, Evaxion EVX-01	Investigational	Other	Moderate	Phase 1 clinical trials for cancer (Evaxion Biotech). AI-designed personalized cancer vaccine.
MariTide AMG 133, maridebart cafraglutide	Investigational	Metabolic	Moderate	Phase 2 clinical trials for obesity (Amgen). GLP-1/GIPR antagonist combination.
Mazdutide IBI362, LY3305677	Investigational	Metabolic	High	Phase 3 clinical trials for obesity and T2D (Innovent Biologics). GLP-1/glucagon dual agonist.
mRNA-4157/V940 V940, mRNA-4157	Investigational	Other	High	Phase 3 clinical trials for melanoma (Moderna). Personalized mRNA cancer vaccine, used with pembrolizumab.
Murepavadin POL7080, RG7929	Investigational	Immune	Moderate	Clinical trials for Pseudomonas aeruginosa infections. Outer membrane protein-targeting antibiotic peptide.
Orforglipron LY3502970, OWL833	Investigational	Metabolic	High	Phase 3 clinical trials for obesity and T2D (Eli Lilly). Oral non-peptide GLP-1 agonist.
Oveporexton TAK-861	Investigational	Cognitive	Moderate	Phase 1 clinical trials for obesity (Novo Nordisk). Next-gen anti-obesity candidate.
Pemvidutide ALT-801, GLP-1/Glucagon Dual Agonist	Investigational	Metabolic	Moderate	Phase 2 clinical trials for obesity and MASH (Altimmune). GLP-1/glucagon dual agonist.
Retatrutide LY3437943, GGG Triple Agonist	Investigational	Metabolic	High	Phase 3 clinical trials for obesity and T2D (Eli Lilly). Triple agonist (GLP-1/GIP/glucagon).
SS-31 Elamipretide, Bendavia	Investigational	Longevity	Moderate	Phase 3 clinical trials as elamipretide for mitochondrial diseases (Stealth BioTherapeutics).
Sulanemadlin ALRN-6924, MP-4897	Investigational	Other	Moderate	Phase 2 clinical trials for solid tumors. MDM2 inhibitor reactivating p53.
Survodutide BI 456906, BI-456906	Investigational	Metabolic	High	Phase 3 clinical trials for obesity and MASH (Boehringer Ingelheim). GLP-1/glucagon dual agonist.
VK2735 Viking 2735	Investigational	Metabolic	Moderate	Phase 2 clinical trials for obesity (Viking Therapeutics). GLP-1/GIP dual agonist.
Zelenectide Pevedotin BT8009, Bicycle Drug Conjugate BT8009	Investigational	Other	Moderate	Phase 1 clinical trials for solid tumors. Antibody-drug conjugate.
5-Amino-1MQ 5-Amino-1-Methylquinolinium, NNMT Inhibitor	Research Only	Metabolic	Low	Not FDA-approved. Small molecule NNMT inhibitor. Preclinical research on metabolism and fat loss.
Alpha-Defensins HNP-1, HNP-2	Research Only	Immune	Moderate	Not FDA-approved as therapeutics. Naturally occurring antimicrobial peptides. Preclinical research.
AOD-9604 Anti-Obesity Drug 9604, Tyr-hGH Fragment 177-191	Research Only	Metabolic	Low	Not FDA-approved. Fragment of human growth hormone (hGH 176-191). Phase 2 trials for obesity showed limited efficacy.
BPC-157 Body Protection Compound-157, Bepecin	Research Only	Recovery	Low	Not FDA-approved. Extensive preclinical research but no completed human clinical trials. Available through compounding p...
Bronchogen AEDL, Ala-Glu-Asp-Leu	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for bronchial tissue. Available in Russia.
Cardiogen AED, Ala-Glu-Asp	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for cardiovascular tissue. Available in Russia.
Cartalax AED peptide, Ala-Glu-Asp	Research Only	Recovery	Low	Not approved by any regulatory agency. Classified as a research peptide. Part of Khavinson's bioregulator framework deve...
Cerebrolysin FPF-1070, N-PEP-12	Research Only	Cognitive	Moderate	Not FDA-approved in US. Approved in 45+ countries for stroke and dementia. Porcine brain-derived peptide mixture.
Cerluten Brain cytamin, Cerebral peptides	Research Only	Cognitive	Low	Not FDA-approved. Khavinson bioregulator peptide for brain tissue. Available in Russia.
Chonluten EDG-GI, Glu-Asp-Gly (GI)	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for respiratory mucosa. Available in Russia.
CJC-1295 DAC:GRF, Modified GRF 1-29	Research Only	Hormonal	Moderate	Not FDA-approved. Modified GHRH analog. Limited clinical research; widely used in anti-aging clinics.
Cortexin Cortexinum, Polypeptide brain extract	Research Only	Cognitive	Moderate	Not FDA-approved in US. Approved in Russia for neurological conditions. Brain-derived peptide complex.
Dihexa PNB-0408, N-hexanoic-Tyr-Ile-(6) aminohexanoic amide	Research Only	Cognitive	Very-low	Not FDA-approved. Angiotensin IV analog. Preclinical research on cognitive enhancement.
DSIP Delta Sleep Inducing Peptide, Delta Sleep-Inducing Peptide	Research Only	Cognitive	Moderate	Not FDA-approved. Delta sleep-inducing peptide. Limited and conflicting research results.
Endoluten Pineal cytamin, Pineal gland peptides	Research Only	Longevity	Low	Not FDA-approved. Khavinson bioregulator peptide for pineal gland. Available in Russia.
Epithalon Epitalon, Epithalone	Research Only	Longevity	Low	Not FDA-approved. Synthetic tetrapeptide studied for telomerase activation. Developed by Prof. Khavinson; limited clinic...
Follistatin FST, FS-344	Research Only	Hormonal	Moderate	Not FDA-approved. Naturally occurring glycoprotein. Preclinical research on muscle growth and fibrosis.
FOXO4-DRI FOXO4-D-Retro-Inverso, FOXO4-DRI Peptide	Research Only	Longevity	Very-low	Not FDA-approved. Senolytic peptide. Preclinical research only; studied for selective clearance of senescent cells.
GHK Glycyl-Histidyl-Lysine, GHK tripeptide	Research Only	Recovery	Moderate	Not FDA-approved. Naturally occurring tripeptide. Extensive in-vitro and animal research on wound healing and skin repai...
GHK-Cu Copper Peptide GHK, Glycyl-L-Histidyl-L-Lysine:Copper	Research Only	Recovery	Moderate	Not FDA-approved. Copper-bound GHK peptide. Available in cosmetic formulations. Preclinical research on tissue repair.
GHRP-2 Growth Hormone Releasing Peptide-2, Pralmorelin	Research Only	Hormonal	Moderate	Not FDA-approved. Growth hormone releasing peptide. Limited clinical research.
GHRP-6 Growth Hormone Releasing Peptide-6, SKF-110679	Research Only	Hormonal	Moderate	Not FDA-approved. Growth hormone releasing peptide. Limited clinical research.
Hexarelin Examorelin, HEX	Research Only	Hormonal	Moderate	Not FDA-approved. Growth hormone secretagogue. Limited clinical research, some cardioprotective studies.
Humanin HN, HNG	Research Only	Longevity	Moderate	Not FDA-approved. Mitochondrial-derived peptide. Preclinical research on neuroprotection and metabolic health.
IGF-1 LR3 Long R3 IGF-1, LR3-IGF-1	Research Only	Hormonal	Low	Not FDA-approved. Modified IGF-1 analog. Note: natural IGF-1 (mecasermin/Increlex) is FDA-approved for growth failure.
Ipamorelin NNC 26-0161, NNC-26-0161	Research Only	Hormonal	Moderate	Not FDA-approved. Growth hormone releasing peptide. Preclinical and limited clinical research.
Kisspeptin KISS1, Metastin	Research Only	Hormonal	Moderate	Not FDA-approved. Naturally occurring neuropeptide. Active research in reproductive endocrinology.
KPV Lys-Pro-Val, Lysine-Proline-Valine	Research Only	Immune	Low	Not FDA-approved. Tripeptide fragment of alpha-MSH. Preclinical research on anti-inflammatory effects.
Kristagen EDG, Glu-Asp-Gly	Research Only	Immune	Low	Not FDA-approved. Khavinson bioregulator peptide for immune system. Available in Russia.
Lactoferricin LFcinB, Lactoferricin B	Research Only	Immune	Low	Not FDA-approved. Antimicrobial peptide derived from lactoferrin. Preclinical research on antimicrobial and anticancer p...
Livagen KED, Lys-Glu-Asp	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for liver tissue. Available in Russia.
LL-37 Cathelicidin, hCAP18	Research Only	Immune	Moderate	Not FDA-approved. Human cathelicidin antimicrobial peptide. Preclinical research on infection and wound healing.
Melanotan II MT-II, MT-2	Research Only	Other	Moderate	Not FDA-approved. Research peptide for tanning/sexual dysfunction. Significant safety concerns; not recommended for huma...
MK-677 Ibutamoren, Ibutamoren Mesylate	Research Only	Hormonal	Moderate	Not FDA-approved. Oral growth hormone secretagogue (ibutamoren). Phase 2 trials completed but development discontinued.
MOTS-c Mitochondrial ORF of the 12S rRNA type-c, Mitochondrial-derived peptide	Research Only	Longevity	Low	Not FDA-approved. Mitochondrial-derived peptide. Preclinical research on metabolism and exercise mimetics.
N-Acetyl Selank Amidate NA-Selank, N-Acetyl Selank	Research Only	Cognitive	Very-low	Not FDA-approved. Modified form of selank. Research compound only.
N-Acetyl Semax Amidate NA-Semax, N-Acetyl Semax	Research Only	Cognitive	Very-low	Not FDA-approved. Modified form of semax. Research compound only.
Ovagen EDL, Glu-Asp-Leu	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for liver and GI tract. Available in Russia.
P21 Ac-DGGLAG-NH2, P021	Research Only	Cognitive	Very-low	Not FDA-approved. Synthetic peptide fragment of CNTF. Preclinical research on neurogenesis.
Pancragen KEDW, Lys-Glu-Asp-Trp	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for pancreatic tissue. Available in Russia.
Pinealon EDR, Glu-Asp-Arg	Research Only	Cognitive	Low	Not FDA-approved. Khavinson bioregulator peptide for brain tissue. Synthetic tripeptide.
Prostatilen Prostate peptide extract, Samprost	Research Only	Hormonal	Moderate	Not FDA-approved in US. Approved in Russia for prostate conditions. Bovine prostate-derived peptide.
Retinalamin Retinal peptide complex, Eye peptide	Research Only	Other	Moderate	Not FDA-approved in US. Approved in Russia for retinal conditions. Bovine retina-derived peptide.
Selank TP-7, Selanc	Research Only	Cognitive	Moderate	Not FDA-approved in US. Approved in Russia as an anxiolytic. Synthetic analog of tuftsin.
Semax ACTH(4-7)PGP, Methionyl-Glutamyl-Histidyl-Phenylalanyl-Prolyl-Glycyl-Proline	Research Only	Cognitive	Moderate	Not FDA-approved in US. Approved in Russia for stroke recovery and cognitive enhancement.
Sermorelin Geref, GRF 1-29	Research Only	Hormonal	Moderate	Previously FDA-approved (Geref) for growth hormone deficiency diagnosis. Withdrawn from market but available through com...
SHLP-2 Small Humanin-Like Peptide 2, SHLP2	Research Only	Longevity	Low	Not FDA-approved. Small humanin-like peptide 2. Early preclinical research on mitochondrial function.
SHLP-6 Small Humanin-Like Peptide 6, SHLP6	Research Only	Longevity	Low	Not FDA-approved. Small humanin-like peptide 6. Early preclinical research.
Sigumir Cartilage cytamin, Joint peptides	Research Only	Recovery	Low	Not FDA-approved. Khavinson bioregulator peptide for cartilage and bone. Available in Russia.
SLU-PP-332 ERR agonist 332, Exercise mimetic compound	Research Only	Metabolic	Very-low	Not FDA-approved. ERR agonist (exercise mimetic). Early preclinical research.
Stamakort Gastric peptide, Stomach bioregulator	Research Only	Other	Very-low	Not FDA-approved. Khavinson bioregulator peptide for stomach tissue. Available in Russia.
Suprefort Pancreatic cytamin, Pancreas peptides	Research Only	Other	Very-low	Not FDA-approved. Khavinson bioregulator peptide for pancreatic tissue. Available in Russia.
Svetinorm Liver cytamin, Hepatic peptides	Research Only	Other	Very-low	Not FDA-approved. Khavinson bioregulator peptide for liver tissue. Available in Russia.
TB-500 Thymosin Beta-4 Fragment, TB4-FRAG	Research Only	Recovery	Moderate	Not FDA-approved. Synthetic fragment of thymosin beta-4. Preclinical research only. Used in veterinary and research sett...
Testagen Testicular peptide, Gonad peptide	Research Only	Hormonal	Low	Not FDA-approved. Khavinson bioregulator peptide for testicular tissue. Available in Russia.
Thymalin Thymulin, Thymic Factor	Research Only	Immune	Moderate	Not FDA-approved in US. Approved in Russia. Thymic peptide bioregulator developed by Prof. Khavinson.
Thymogen Glu-Trp, EW dipeptide	Research Only	Immune	Moderate	Not FDA-approved in US. Approved in Russia as immunomodulator. Synthetic thymic dipeptide.
Thymosin Alpha-1 Ta1, Thymalfasin	Research Only	Immune	Moderate	Not FDA-approved in US. Approved in 35+ countries (Zadaxin) for hepatitis B/C and as immune modulator.
Thymulin FTS, Facteur Thymique Serique	Research Only	Immune	Moderate	Not FDA-approved. Naturally occurring thymic nonapeptide. Preclinical research on immune modulation.
Ventfort Vascular cytamin, Blood vessel peptides	Research Only	Other	Very-low	Not FDA-approved. Khavinson bioregulator peptide for vascular tissue. Available in Russia.
Vesugen KED-vascular, Lys-Glu-Asp (vascular)	Research Only	Other	Low	Not FDA-approved. Khavinson bioregulator peptide for vascular tissue. Synthetic tripeptide.
Vilon KE, Lys-Glu	Research Only	Immune	Low	Not FDA-approved. Khavinson bioregulator peptide for immune system. Synthetic dipeptide.
Vladonix Thymus cytamin, Thymic peptide supplement	Research Only	Immune	Low	Not FDA-approved. Khavinson bioregulator peptide for thymus. Available in Russia.

94 of 94 peptides shown

Disclaimer: This tracker is for informational purposes only. Regulatory status reflects publicly available information from FDA, ClinicalTrials.gov, and manufacturer disclosures. Status may change without notice. This is not medical or legal advice. Always verify current regulatory status through official channels before making any decisions.