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Peptide Regulations
by Country

Regulatory status varies significantly by country and by peptide. This guide compiles the current legal framework for research peptides across five major jurisdictions.

Regulatory Frameworks

🇺🇸 United States

The FDA regulates peptides as drugs, biologics, or dietary supplement ingredients depending on their intended use. Research peptides sold without health claims fall under the Research Use Only (RUO) framework. Compounding pharmacies operate under Section 503A (patient-specific prescriptions, state-regulated) or Section 503B (outsourcing facilities, FDA-inspected). The FDA maintains bulk drug substance lists (Category 1 = eligible, Category 2 = under review or restricted). Most research peptides are not FDA-approved for any human indication. WADA prohibits many peptides in competitive sports.

🇨🇦 Canada

Health Canada classifies therapeutic peptides as prescription drugs requiring a Drug Identification Number (DIN) or Notice of Compliance for sale. Peptides without Canadian approval are not legally sold as health products. The grey market exists for research peptides, but Health Canada periodically issues warnings and seizures. Personal importation of small quantities for personal use may be tolerated under the Personal Importation Policy, though this does not apply to controlled substances.

🇬🇧 United Kingdom

The MHRA classifies most therapeutic peptides as Prescription Only Medicines (POM). Since Brexit, UK regulatory pathways are independent of the EMA. Research peptides may be sold for legitimate research purposes but cannot be marketed for human consumption. The MHRA conducts enforcement actions against unlicensed peptide sellers. Customs may seize imported peptides without proper documentation.

🇪🇺 European Union

The European Medicines Agency (EMA) coordinates the centralized authorization procedure for novel drugs across EU member states. Peptides approved centrally (e.g., semaglutide) receive marketing authorization valid in all member states. Non-approved peptides fall under individual member state regulation, which varies significantly. Some countries enforce stricter import controls than others. Research-use peptides exist in a regulatory grey area that differs by jurisdiction.

🇦🇺 Australia

The Therapeutic Goods Administration (TGA) regulates peptides under the Therapeutic Goods Act 1989. Most injectable peptides are classified as Schedule 4 (prescription only) or Schedule 8 (controlled). The TGA's Personal Importation Scheme allows individuals to import up to 3 months' supply of prescription medicines with a valid prescription, but this does not extend to unapproved substances. The TGA has conducted multiple enforcement operations targeting peptide suppliers.

Comparison Matrix

Side-by-side regulatory status for 234 peptides across all five jurisdictions.

Peptide🇺🇸US🇨🇦CA🇬🇧UK🇪🇺EU🇦🇺AU
5-Amino-1MQ
9-Me-BCNot FDA-approved. Sold as a research chemical.Not approved by Health Canada.Not MHRA-approved. May fall under Novel Psychoactive Substances Act.Not EMA-approved. Regulatory status varies by member state.Not TGA-approved.
AbaloparatideFDA-approved. Tymlos (abaloparatide 80 mcg SC injection) approved April 2017...Health Canada approved (Tymlos).Not MHRA-approved as of 2025.Not EMA-approved. Marketing authorization application was withdrawn by the...Not TGA-approved as of 2025.
ACE-031Development discontinued (Acceleron Pharma, 2013). Not FDA-approved. Available...
Acetyl Tetrapeptide-3Marketed as a cosmetic ingredient. Not FDA-regulated as a drug.Available as a cosmetic ingredient. No Health Canada drug approval required.Cosmetic ingredient, regulated under cosmetic product safety regulations.Listed in CosIng database as a cosmetic ingredient.Available in cosmetic products. Not TGA-regulated.
Acetyl Tetrapeptide-5Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
AdamaxUnregulated research chemical. Not FDA-approved or reviewed.
AdipotideNot FDA-approved. Research compound only. Clinical development discontinued.
AdrenomedullinNot approved as a therapeutic agent. MR-proADM assay (BRAHMS/Thermo Fisher)...Not approved as a therapeutic agent. MR-proADM assay available for research.Not approved as a therapeutic agent. MR-proADM used in some centers for sepsis...Not approved as a therapeutic agent. MR-proADM assay (BRAHMS) CE-marked for...Not approved as a therapeutic agent.
AfamelanotideFDA-approved (Scenesse, October 2019) for EPP. Available only through a...Not approved by Health Canada as of 2025.MHRA approved (Scenesse) for EPP.EMA-approved (Scenesse, December 2014) under exceptional circumstances for EPP.TGA-approved (Scenesse) for EPP.
AHK (Ala-His-Lys)
AHK-Cu (Copper AHK)
AICARNot FDA-approved. Investigational drug (acadesine) for cardiac ischemia....
AlbiglutidePreviously FDA-approved (Tanzeum, April 2014). Voluntarily withdrawn from US...Was not marketed in Canada.Previously MHRA approved (Eperzan). Withdrawn from European market in 2018.Previously EMA-approved (Eperzan, March 2014). Marketing authorization...Was not marketed in Australia.
AlexamorelinNot FDA-approved. Research chemical only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Alpha-DefensinsEndogenous human peptides. Synovasure alpha-defensin diagnostic test is...No therapeutic product.No therapeutic product.No therapeutic product.No therapeutic product.
AmycretinInvestigational. Not FDA-approved. Phase 3 trials expected 2026.Investigational. Not EMA-approved.
AmylinEndogenous hormone. Not itself a regulated drug. Pramlintide (synthetic analog)...Endogenous hormone. Not regulated as a drug.Endogenous hormone. Not regulated as a drug.Endogenous hormone. Not regulated as a drug.Endogenous hormone. Not regulated as a drug.
AnamorelinNot FDA-approved. Phase III trials completed but not submitted for approval due...Not approved by Health Canada.Not EMA-approved.
Angiotensin 1-7Not approved. Research compound only. No FDA-approved products.Not approved. Research use only.Not approved. Research use only.Not approved. Research use only.Not approved. Research use only.
Angiotensin IIFDA-approved (Giapreza, December 2017) for treatment of hypotension in adults...Not approved as of 2025.Not approved. Angiotensin II is available for research use only.Not approved by EMA.Not approved by TGA.
AOD-9604Not FDA-approved as a drug. FDA granted GRAS status for food use (2014)....Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.TGA GRAS-equivalent status for oral cartilage formulation. Not approved as...
ApelinNot approved. Research compound only.Not approved. Research use only.Not approved. Research use only.Not approved. Research use only.Not approved. Research use only.
ARA-290 (Cibinetide)Not FDA-approved. FDA Orphan Drug Designation granted for...Not approved by Health Canada.Not MHRA-approved. Clinical trials conducted in the Netherlands and EU.Not EMA-approved. EMA Orphan Designation granted for sarcoidosis. Phase II...Not TGA-approved.
ArgirelineNot FDA-regulated as a drug. Sold as a cosmetic ingredient. INCI name: Acetyl...Approved cosmetic ingredient under EU Cosmetic Regulation.
Astressin-BNot FDA-approved. Research peptide only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Atrial Natriuretic PeptideNot approved. ANP is used as a research reagent. NT-proANP/MR-proANP used as...Not approved as a therapeutic agent.Not approved as a therapeutic agent.Not approved as a therapeutic agent.Not approved as a therapeutic agent.
B-type Natriuretic PeptideBNP and NT-proBNP assays are FDA-cleared as diagnostic aids for heart failure....BNP/NT-proBNP assays approved for diagnostic use. Nesiritide not approved.BNP/NT-proBNP assays approved. NICE recommends NT-proBNP as first-line...BNP/NT-proBNP assays widely available. ESC guidelines recommend natriuretic...BNP/NT-proBNP assays available. Nesiritide not approved by TGA.
B7-33
BAM-15Not FDA-approved. Research compound only.Not approved.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Beta-DefensinsEndogenous human peptides. No therapeutic product. Not subject to FDA drug...No therapeutic product.No therapeutic product.No therapeutic product. Studied in academic research.No therapeutic product.
Biotinoyl Tripeptide-1Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
BivalirudinFDA-approved (Angiomax, 2000) for PCI anticoagulation in unstable angina and...Health Canada approved (Angiomax).MHRA approved (Angiox) for PCI anticoagulation.EMA-approved (Angiox, 2004) for PCI in ACS patients.TGA-approved (Angiomax/Angiox).
BPC-157Not FDA-approved. Removed from Category 2 on April 15, 2026 after HHS Secretary...Not approved by Health Canada. Available through grey market only.Not approved by MHRA. No legal framework for sale as medicine.Not EMA-approved. Regulatory status varies by member state.Schedule 4 (prescription only) under TGA. Not approved for therapeutic use.
BPC-157 + TB-500
BradykininNot an approved drug. Available as research reagent. Bradykinin pathway...Not an approved drug. Icatibant and lanadelumab approved for HAE.Not an approved drug. Icatibant approved (MHRA) for HAE.Not an approved drug. Icatibant approved (EMA) for HAE.Not an approved drug. Icatibant approved (TGA) for HAE.
BremelanotideFDA-approved (Vyleesi, June 2019) for premenopausal HSDD. Schedule not...Not approved by Health Canada as of 2025.Not approved by MHRA as of 2025.Not EMA-approved as of 2025.Not TGA-approved as of 2025.
BrilacidinNot FDA-approved. Phase II completed for ABSSSI. No Phase III initiated....Not approved by Health Canada.Not approved by MHRA.Not EMA-approved.Not TGA-approved.
BronchogenResearch peptide. Not FDA-approved.
BuserelinNot FDA-approved. Not commercially available in the US.Health Canada approved (Suprefact, Suprefact Depot) for prostate cancer and...MHRA approved (Suprecur nasal spray, Suprefact injection). Used for prostate...Approved in multiple EU member states (Suprefact, Suprecur) for prostate...TGA-approved (Suprefact, Suprecur). Used for prostate cancer, endometriosis,...
CagrilintideNot yet FDA-approved. NDA filed by Novo Nordisk in 2026 for CagriSema...Not approved. Regulatory filing anticipated.
CAGRILINTIDE + SEMAGLUTIDE
Calcitonin (Salmon)FDA-approved. Miacalcin injection (1986) for Paget disease and hypercalcemia;...Health Canada approved. Nasal spray available for postmenopausal osteoporosis.MHRA: nasal spray restricted following EMA review. Limited to short-term use...EMA restricted calcitonin use in 2012: nasal spray withdrawn; injection limited...TGA-approved. Available as nasal spray and injection.
Calcitonin SalmonFDA-approved. Miacalcin nasal spray (200 IU/dose) and injection (200 IU/mL)...Health Canada approved (Miacalcin).MHRA: nasal spray withdrawn from market in 2012 following EMA review of cancer...EMA restricted use in 2012: intranasal formulations withdrawn; injectable forms...TGA-approved (Miacalcin). Available as nasal spray and injection.
CarbetocinNot FDA-approved. Not commercially available in the US.Health Canada approved (Duratocin) for prevention of uterine atony after...MHRA approved (Pabal) for prevention of uterine atony after cesarean delivery.Approved in multiple EU member states (Pabal/Duratocin) for cesarean delivery...TGA-approved (Pabal) for prevention of uterine atony following delivery by...
CardiogenResearch peptide. Not FDA-approved.
Cartalax
CerebrolysinNot FDA-approved. No IND application. Cannot be legally prescribed.Approved in several EU member states (Austria, Germany, Czech Republic) for...Not TGA-approved.
CerlutenNot FDA-approved. Not recognized as a therapeutic or supplement.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
CetrorelixFDA-approved (Cetrotide 0.25 mg and 3 mg kits). Indicated for inhibition of...Health Canada approved (Cetrotide).MHRA approved (Cetrotide).EMA-approved (Cetrotide). Widely used in European IVF protocols.TGA-approved (Cetrotide).
CGRPCGRP is an endogenous peptide. Anti-CGRP therapies are FDA-approved: erenumab...Anti-CGRP therapies approved by Health Canada.Anti-CGRP therapies approved by MHRA and available via NHS for eligible...Anti-CGRP therapies EMA-approved.Anti-CGRP therapies TGA-approved.
Cholecystokinin (CCK)Sincalide (Kinevac) is FDA-approved as a diagnostic agent for gallbladder and...Sincalide available as a diagnostic agent.Available as a diagnostic agent under MHRA oversight.Available as a diagnostic tool. Not approved for obesity.Available for diagnostic use under TGA.
ChonlutenResearch peptide. Not FDA-approved.
CJC-1295Not FDA-approved. Research chemical only. WADA-banned under Section S2 (growth...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved for therapeutic use.
CJC-1295 with DACNot FDA-approved. Research compound only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Collagen PeptidesMarketed as dietary supplement under DSHEA. GRAS status. Not FDA-approved as a...Available as natural health product (NPN).Available as food supplement.Available as food supplement. EFSA has not approved specific health claims for...Available as food supplement/complementary medicine.
Copper Tripeptide-1Cosmetic ingredient. Not FDA-regulated as a drug for cosmetic claims.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
CortagenNot FDA-approved or evaluated. Occasionally sold online as a research peptide.Not approved by Health Canada.Not approved by MHRA.Not EMA-approved. Available in Russia as a dietary supplement.Not TGA-approved.
CortexinNot FDA-approved. No IND application.Not MHRA-approved.Not EMA-approved.
CotadutideInvestigational. Phase II completed. Not FDA-approved. Phase III status unclear.Not approved. Investigational.Not approved. Investigational. Developed by AstraZeneca (Cambridge, UK).Not approved. Investigational.Not approved. Investigational.
DanuglipronInvestigational. Phase III ongoing (once-daily modified-release). Not...Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.
Decapeptide-12
DegarelixFDA-approved (Firmagon, December 2008) for advanced prostate cancer. 240 mg...Health Canada approved (Firmagon).MHRA approved (Firmagon). NICE recommended for prostate cancer where GnRH...EMA-approved (Firmagon, February 2009) for advanced hormone-dependent prostate...TGA-approved (Firmagon). PBS-listed for advanced prostate cancer.
DemoxytocinNot FDA-approved. Available as research compound.Not approved by Health Canada.Not widely available. Historical use in some member states.Not TGA-approved.
DermorphinResearch chemical only. Not FDA-approved. DEA Schedule status varies.
DesirudinFDA-approved (Iprivask, 2003) for DVT prophylaxis in patients undergoing...Previously approved (Revasc); availability varies.Previously authorized (Revasc); limited current availability.Previously EMA-authorized (Revasc) for DVT prophylaxis post hip/knee surgery....Not currently TGA-approved.
DesmopressinFDA-approved (DDAVP tablets, nasal spray, injection; Stimate nasal spray for...Health Canada approved (DDAVP, Minirin, generics).MHRA approved (DDAVP, Desmotabs, Desmomelt). NICE recommended for nocturnal...EMA-approved in member states (Minirin, DDAVP, generics).TGA-approved (DDAVP, Minirin). PBS-listed for diabetes insipidus and nocturnal...
DifelikefalinFDA-approved (Korsuva, August 2021) for moderate-to-severe CKD-associated...Health Canada approved (Korsuva, 2022).MHRA approved (Kapruvia, 2022).EMA-approved (Kapruvia, April 2022) for CKD-associated pruritus in adult...TGA-approved (Kapruvia).
DihexaNot FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
DS-5Research compound only.
DSIPNot FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
DulaglutideFDA-approved. Trulicity approved September 2014 for T2D (0.75 mg and 1.5 mg)....Health Canada approved (Trulicity).MHRA approved. NICE recommended for T2D.EMA-approved (Trulicity, November 2014).TGA-approved (Trulicity). PBS-listed for T2D.
EloralintideInvestigational New Drug (IND). Phase II trials ongoing. Not FDA-approved.
EnclomipheneNot FDA-approved. FDA declined approval in 2015 citing need for additional...
Endothelin-1ET-1 is not an approved drug. Available as research reagent. ERAs approved:...ET-1 not approved as drug. ERAs (bosentan, ambrisentan, macitentan) approved...ET-1 not approved as drug. ERAs approved by MHRA for PAH.ET-1 not approved as drug. ERAs approved by EMA for PAH.ET-1 not approved as drug. ERAs approved by TGA for PAH.
EnfuvirtideFDA-approved (Fuzeon, March 2003) for HIV-1 infection in combination with other...Health Canada approved (Fuzeon).MHRA approved (Fuzeon).EMA-approved (Fuzeon, May 2003).TGA-approved (Fuzeon).
EpithalonNot FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
EptifibatideFDA-approved (Integrilin, 1998) for ACS managed medically or with PCI. Generic...Health Canada approved (Integrilin).MHRA approved (Integrilin).EMA-approved (Integrilin, 1999).TGA-approved (Integrilin).
ExenatideFDA-approved. Byetta (exenatide immediate-release) approved April 2005....Health Canada approved (Byetta, Bydureon).MHRA approved. NICE recommended for T2D in specific patient populations.EMA-approved (Byetta 2006, Bydureon 2011).TGA-approved (Byetta, Bydureon). PBS-listed for T2D.
FGL(S)
FollistatinNot FDA-approved for any indication. Research compound. Gene therapy...
Follistatin 344
Follistatin-315
FOXO4-DRINot FDA-approved. Research chemical only. No IND application filed.Not approved. Investigational.Not TGA-approved.
FOXO4-DRIResearch compound only. No regulatory status.
GanirelixFDA-approved (ganirelix acetate injection 250 mcg/0.5 mL) for prevention of...Health Canada approved (Orgalutran).MHRA approved (Fyremadel/Orgalutran).EMA-approved (Orgalutran/Fyremadel). Widely used in European IVF protocols.TGA-approved (Orgalutran).
GDF-11Not FDA-approved. Research reagent only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
GHKCosmetic ingredient. Not FDA-approved as drug. Research compound.
GHK (Glycyl-Histidyl-Lysine)
GHK-CuAvailable as a cosmetic ingredient (Copper Tripeptide-1). Not FDA-approved as a...Available in cosmetics. Not approved as a therapeutic agent.Available in cosmetics. Not MHRA-approved as a drug.Available in cosmetics under EU cosmetic regulations.Available in cosmetics. Not TGA-approved for therapeutic use.
GhrelinNot FDA-approved for exogenous use. Analog anamorelin not FDA-approved....Not approved.Anamorelin rejected by EMA (did not improve overall survival despite weight...Not TGA-approved.
GHRP-2Not FDA-approved. Research chemical only. Banned by WADA.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
GHRP-6Not FDA-approved. Research chemical only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved. Banned by WADA.
GLP-1Multiple GLP-1 RAs FDA-approved: semaglutide (Ozempic, Wegovy, Rybelsus),...Health Canada approved for multiple GLP-1 RAs.NICE-approved for semaglutide and tirzepatide.EMA-approved for multiple GLP-1 RAs.TGA-approved. PBS-listed for diabetes; weight loss indication expanding.
GlucagonFDA-approved. GlucaGen (IM/SC/IV injection, reconstitution required). Baqsimi...Health Canada approved (GlucaGen, Baqsimi).MHRA approved (GlucaGen HypoKit). Baqsimi approved.EMA-approved (GlucaGen, Baqsimi).TGA-approved (GlucaGen).
GlutathioneAvailable as dietary supplement (oral); injectable forms used in clinical...
GonadorelinFDA-approved (Factrel for pituitary diagnostic testing). Lutrepulse (pulsatile...Available for diagnostic use.Available in various formulations across EU member states.Available for diagnostic and reproductive use.
GoserelinFDA-approved (Zoladex 3.6 mg monthly implant, 10.8 mg every-3-month implant)....Health Canada approved (Zoladex).MHRA approved (Zoladex). NICE recommended for prostate cancer and breast cancer.EMA-approved in member states (Zoladex).TGA-approved (Zoladex). PBS-listed for prostate cancer, breast cancer, and...
Growth HormoneFDA-approved (multiple brands: Genotropin, Norditropin, Humatrope, Saizen,...Health Canada-approved for GH deficiency and other indications.MHRA/NICE-approved. Available on NHS for approved indications.EMA-approved (multiple brands including biosimilars).TGA-approved. PBS-listed for approved indications under specialist prescription.
HCGFDA-approved (Pregnyl, Novarel, Ovidrel). Compounding restricted since 2020...TGA-approved. Schedule 4 (prescription only).
HexarelinNot FDA-approved. Development discontinued. Research chemical only.Not approved.Not approved. Clinical development abandoned.Not TGA-approved.
HGH 191AAFDA-approved. Multiple brands: Genotropin, Humatrope, Norditropin, Saizen,...
HGH Fragment 176-191Not FDA-approved. Research chemical only. WADA-banned.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.AOD-9604 (stabilized analog) was granted GRAS status by FDA for food use. Not...
Histatin-5Endogenous human peptide. No therapeutic product. Not subject to FDA drug...No therapeutic product.No therapeutic product.No therapeutic product.No therapeutic product.
HistrelinFDA-approved. Vantas (histrelin 50 mg subcutaneous implant, 12-month) for...Health Canada approved (Vantas).Available for specialist use.Available in select EU member states.TGA-approved. Available for prostate cancer.
HMGFDA-approved (Menopur by Ferring Pharmaceuticals) for fertility treatment.Health Canada approved.MHRA-approved for fertility treatment.EMA-approved for fertility treatment across member states.TGA-approved for controlled ovarian stimulation.
Human Relaxin-2Not FDA-approved. Development halted after RELAX-AHF-2 failure.Not approved.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
HumaninNot FDA-approved. Research chemical only.Not approved. Investigational.
IcatibantFDA-approved (Firazyr, August 2011) for acute HAE attacks in adults 18 years...Health Canada approved (Firazyr).MHRA approved (Firazyr) for acute HAE attacks.EMA-approved (Firazyr, July 2008) for acute HAE attacks in adults.TGA-approved (Firazyr).
IGF-1FDA-approved (Increlex, mecasermin) for severe primary IGF-1 deficiency....Available through Health Canada Special Access Programme.Available through specialist prescribing.EMA-approved (Increlex) for severe primary IGFD.Available through TGA Special Access Scheme.
IGF-1 DESNot FDA-approved. Research chemical only. WADA-banned.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved. WADA-banned.
IGF-1 LR3Not FDA-approved. Research chemical only. WADA-banned (S2 growth factors).Not approved.Not approved.Not approved.Not TGA-approved. ASADA-banned.
IM862Not FDA-approved. Received FDA orphan drug and fast-track designations for...Not approved. Development discontinued.Not approved. Development discontinued.Not approved. Development discontinued.Not approved. Development discontinued.
IpamorelinNot FDA-approved. Research chemical only. WADA-banned (S2 growth factor).Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Schedule 4 under TGA. Not approved for therapeutic use.
KisspeptinNot FDA-approved. Investigational use in clinical trials. WADA-prohibited.Not approved by Health Canada.Not MHRA-approved. Active clinical research at Imperial College London.Not EMA-approved.Not TGA-approved.
Kisspeptin-10Investigational. Not FDA-approved. Research compound.
KPVNot FDA-approved. Removed from FDA Category 2 on April 15, 2026 after HHS...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
KristagenNot FDA-approved. Not recognized as a therapeutic.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
L-Carnitine (Injectable)FDA-approved as Carnitor (IV/oral) for primary carnitine deficiency and ESRD...
LactoferricinNot FDA-approved. Research-use only. Lactoferrin (parent protein) has GRAS...Not approved by Health Canada as a therapeutic.Not approved by MHRA.Not EMA-approved. Lactoferrin (parent) permitted as a food ingredient.Not TGA-approved as a therapeutic.
LanreotideFDA-approved. Somatuline Depot approved 2007 for acromegaly; 2014 for GEP-NETs...Health Canada approved (Somatuline Autogel).MHRA approved. NICE recommended for acromegaly and GEP-NETs.EMA-approved (Somatuline Autogel). Available across member states.TGA-approved (Somatuline Autogel). PBS-listed.
LarazotideNot FDA-approved. Phase III trial (INN-202) completed. FDA Fast Track...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
LeuprolideFDA-approved. Lupron Depot (1-month, 3-month, 4-month, 6-month depot): prostate...Health Canada approved (Lupron Depot, Eligard).MHRA approved (Prostap). NICE recommended for prostate cancer and endometriosis.EMA-approved in member states under various brand names (Eligard, Enantone,...TGA-approved (Lucrin Depot, Eligard). PBS-listed for prostate cancer and...
LinaclotideFDA-approved. Linzess approved August 2012. Available in 72 mcg (CIC), 145 mcg...Health Canada approved (Constella).MHRA approved (Constella). NICE recommended for IBS-C.EMA-approved (Constella, November 2012) for IBS-C.TGA-approved (Linzess).
LiraglutideFDA-approved: Victoza (T2D, 2010), Saxenda (obesity, 2014). Prescription only.Health Canada approved (Victoza, Saxenda).MHRA/NICE approved.EMA-approved.TGA-approved.
LivagenResearch peptide. Not FDA-approved.
LixisenatideFDA-approved. Adlyxin approved July 2016 for T2D. Soliqua 100/33 (insulin...Health Canada approved (Adlyxin).MHRA approved (Lyxumia). NICE recommended in combination with basal insulin for...EMA-approved (Lyxumia, February 2013).TGA-approved (Lyxumia).
LL-37Not FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
MacimorelinFDA-approved (December 2017) as a diagnostic test for adult growth hormone...Not currently approved by Health Canada.Not MHRA-approved.EMA approved (January 2019) as Macrilen for diagnostic use.Not TGA-approved.
MatrixylCosmetic ingredient. Not FDA-regulated as a drug. No pre-market approval...Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient regulated under EC Cosmetics Regulation 1223/2009.Cosmetic ingredient.
Matrixyl 3000Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
MazdutideNot FDA-approved. Not currently in US clinical trials. Development focused on...Not approved. No ongoing regulatory activity.Not approved. No ongoing regulatory activity.Not approved. No ongoing regulatory activity.Not approved. No ongoing regulatory activity.
Melanostatin-DM (Nonapeptide-2)
Melanotan I (Afamelanotide)
Melanotan IINot FDA-approved. FDA has issued warnings against use. Removed from Category 2...Not approved. Health Canada has issued advisories against use.MHRA has issued explicit safety warnings against use.Not approved. Multiple EU member states have issued warnings.TGA reclassified from Schedule 4 (prescription-only) to Schedule 9 (prohibited...
MelittinNot FDA-approved as a drug. Whole bee venom is a licensed biologic for...Not approved by Health Canada as a drug.Not approved by MHRA. Bee venom therapy is practiced in complementary medicine.Not EMA-approved. Bee venom allergen extracts are available for desensitization.Not TGA-approved as a drug.
MGFNot FDA-approved. Research chemical only. WADA-banned.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved. WADA-banned.
MK-677Not FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved. Banned in sport by ASADA.
MOTS-cNot FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved.Not approved.Not approved.Not approved.
Myostatin PropeptideNot FDA-approved. Research compound only.Not approved.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Myristoyl Pentapeptide-17Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
N-Acetyl Epithalon Amidate
N-Acetyl Selank Amidate
N-Acetyl Semax AmidateNot FDA-approved or evaluated. Sold as a research chemical online. No...Not approved by Health Canada.Not approved by MHRA.Not EMA-approved. Semax (parent) is approved in Russia only.Not TGA-approved.
NAD+ (Nicotinamide Adenine Dinucleotide)
NafarelinFDA-approved (Synarel nasal spray) for endometriosis (200 mcg BID for 6 months)...Health Canada approved (Synarel).MHRA approved (Synarel). Used for endometriosis and IVF protocols.Approved in multiple EU member states (Synarel).TGA-approved (Synarel). PBS-listed for endometriosis.
NesiritideFDA-approved (Natrecor, August 2001) for IV treatment of acute decompensated...Not approved by Health Canada.Not approved by MHRA.Not approved by EMA.Not approved by TGA.
Neuromedin UNot FDA-approved. Research compound only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Neuropeptide YEndogenous neuropeptide. No NPY receptor drugs are FDA-approved. Multiple NPY...No NPY-targeting drugs approved.No NPY-targeting drugs approved.No NPY-targeting drugs approved.No NPY-targeting drugs approved.
NeuroxelinUnregulated research chemical. Not FDA-reviewed or approved.
Nonapeptide-1
NoopeptNot FDA-approved or evaluated. Available only as a research chemical or...Not approved by Health Canada.Not approved by MHRA. May fall under Psychoactive Substances Act 2016.Not EMA-approved. Legal status varies by member state.Not TGA-approved. May be classified as a Schedule 4 or prohibited substance.
OctreotideFDA-approved. Sandostatin (immediate-release SC) approved 1988 for acromegaly,...Health Canada approved (Sandostatin, Sandostatin LAR). Generics available.MHRA approved. NICE recommended for acromegaly and NETs.EMA-approved. Widely available across member states with generic formulations.TGA-approved. PBS-listed for acromegaly, carcinoid syndrome, and VIPomas.
Oligopeptide-1 / EGFNot FDA-approved for wound healing. Used as cosmetic ingredient...Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient. Not approved as a medicinal product.Cosmetic ingredient.
OmigananNot FDA-approved. Phase III catheter infection trial did not meet primary...Not approved. Originally developed by Migenix (Vancouver).Not approved by MHRA.Not EMA-approved.Not TGA-approved.
OrforglipronInvestigational. Phase III ATTAIN trials ongoing for T2D and obesity. Not...Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.
OS-01 (OneSkin Peptide)
Ovagen
OxytocinFDA-approved (Pitocin). Used for labor induction, augmentation, and postpartum...Health Canada approved (Syntocinon, Pitocin).MHRA approved (Syntocinon). NICE guidelines recommend for labor induction and...EMA-approved in member states (Syntocinon).TGA-approved (Syntocinon). PBS-listed.
P21Not FDA-approved. Research compound only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
PACAPEndogenous neuropeptide. No PACAP-targeting drugs are FDA-approved. Anti-PACAP...No PACAP-targeting drugs approved.No PACAP-targeting drugs approved.No PACAP-targeting drugs approved. Active academic research, particularly at...No PACAP-targeting drugs approved.
Pal-AHKCosmetic ingredient. Not FDA-regulated as drug.
Pal-GHK (Palmitoyl Tripeptide-1)
Palmitoyl Dipeptide-6Cosmetic ingredient.
Palmitoyl Tetrapeptide-7Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
Palmitoyl Tripeptide-1Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
Palmitoyl Tripeptide-5Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
PancragenResearch peptide. Not FDA-approved.
PasireotideFDA-approved. Signifor (SC) approved December 2012 for Cushing disease....Health Canada approved (Signifor).MHRA approved. NICE evaluated for Cushing disease and acromegaly.EMA-approved (Signifor 2012; Signifor LAR 2014).TGA-approved (Signifor).
PE-22-28Not FDA-evaluated. Research tool compound. Sold by some peptide suppliers as a...Not approved by Health Canada.Not approved by MHRA.Not EMA-approved. Developed by French academic researchers.Not TGA-approved.
PEG-MGFNot FDA-approved. Research chemical only. WADA-prohibited (S2: Growth Factors).Not approved by Health Canada. WADA-prohibited.Not MHRA-approved.Not EMA-approved.Not TGA-approved. WADA-prohibited.
PemvidutideInvestigational. Phase II completed for obesity (MOMENTUM) and NASH (IMPACT)....Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.
Pentapeptide-18 (Leuphasyl)
Peptide YY (PYY)Not FDA-approved as a therapeutic. Research use only. Endogenous hormone.Not approved by Health Canada for therapeutic use.Not MHRA-approved for therapy.Not EMA-approved. Research only.Not TGA-approved for therapeutic use.
PexigananNot FDA-approved. Two NDA submissions (1999, 2016) were unsuccessful....Not approved by Health Canada.Not approved by MHRA.Not EMA-approved.Not TGA-approved.
PGPIPNResearch compound only.
PinealonNot FDA-approved or evaluated. Not available as a pharmaceutical. Occasionally...Not approved by Health Canada.Not approved by MHRA.Not EMA-approved. Available in Russia as a dietary supplement.Not TGA-approved.
PlecanatideFDA-approved. Trulance 3 mg tablets approved January 2017 for CIC; January 2018...Not approved by Health Canada as of 2025.Not MHRA-approved. Not available in the UK.Not EMA-approved. Not marketed in the EU.Not TGA-approved.
PNC-27NOT FDA-approved. FDA has issued explicit warnings that PNC-27 products are...
PramlintideFDA-approved (Symlin, SymlinPen) since March 2005 for T1D and T2D as adjunct to...Not approved by Health Canada.Not approved by MHRA. Not available in the UK.Not EMA-approved. Was never submitted for EU approval.Not TGA-approved. Not available in Australia.
ProstamaxResearch peptide. Not FDA-approved.
ProstatilenNot FDA-approved. Not available as a pharmaceutical.Not approved by Health Canada.Not EMA-approved. Not available in Western European markets.
PT-141FDA-approved (Vyleesi, 2019) for HSDD in premenopausal women. 1.75 mg SC...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
PTD-DBMNot FDA-approved. Research compound only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
PTH (Parathyroid Hormone)FDA-approved (Natpara, January 2015) for hypoparathyroidism. Available only...Health Canada approved (Natpara).Previously available as Preotact (for osteoporosis, withdrawn). Natpara...EMA-approved (Natpar, 2017) for hypoparathyroidism. Marketing authorization...Not TGA-approved as of 2025.
RetatrutideNot FDA-approved. Phase 3 TRIUMPH program ongoing (Eli Lilly). TRIUMPH-4...Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.Not approved. Investigational.
RetinalaminNot FDA-approved. Not available as a pharmaceutical.Not approved by Health Canada.Not EMA-approved.Not TGA-approved.
Rigin (Palmitoyl Tetrapeptide-7)
RomiplostimFDA-approved (Nplate, August 2008) for chronic ITP in adults with insufficient...Health Canada approved (Nplate).MHRA approved (Nplate). NICE recommended for chronic ITP.EMA-approved (Nplate, February 2009) for chronic ITP.TGA-approved (Nplate). PBS-listed for chronic ITP.
SelankNot FDA-approved. Research chemical only.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
SemaglutideFDA-approved (Ozempic, Wegovy, Rybelsus). Additional approvals: MASH with...Health Canada approved (Ozempic, Wegovy).MHRA/NICE approved (Ozempic, Wegovy).EMA-approved.TGA-approved (Ozempic, Wegovy).
SemaxNot FDA-approved. Removed from FDA Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
SermorelinPreviously FDA-approved (Geref) for pediatric GH deficiency; voluntarily...Not currently approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved for therapeutic use.
SetmelanotideFDA-approved. Imcivree approved November 2020 for chronic weight management in...Health Canada approved (Imcivree, 2022).MHRA approved (Imcivree). NICE appraisal completed.EMA-approved (Imcivree, July 2021) for POMC/PCSK1/LEPR deficiency obesity.TGA-approved (Imcivree).
Sh-Polypeptide-1Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
SLU-PP-332Research compound. No FDA filing. Not approved for any use.
Snap-8Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
SomatostatinNot widely marketed as a drug product in the US. Synthetic analogs (octreotide,...Not a standard clinical product. Analogs preferred.Available in limited settings for acute variceal bleeding; somatostatin analogs...Available as Somatostatin UCB or generic IV formulations in some member states...Not a standard therapeutic product. Analogs preferred.
Somatropin (rHGH)FDA-approved (multiple brand names). Schedule III controlled substance when...
SS-31FDA-approved (September 2025) as Forzinity for Barth syndrome — first...Investigational. EMA Orphan Drug designation.
Substance PEndogenous neuropeptide. NK1R antagonists (aprepitant, fosaprepitant,...NK1R antagonists are Health Canada-approved.NK1R antagonists are MHRA-approved. NICE-recommended for CINV prophylaxis.NK1R antagonists are EMA-approved.NK1R antagonists are TGA-approved.
SurvodutideNot FDA-approved. Phase 3 trials ongoing for MASH and obesity. Breakthrough...Not approved. Phase 3 trials ongoing.
SYN-AKE
SYN-COLL (Palmitoyl Tripeptide-5)
TabimorelinNot FDA-approved. Development discontinued.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved. Developed by Novo Nordisk (Denmark); discontinued.Not TGA-approved.
Tat-Beclin 1Research compound. No FDA filing.
TB-500Not FDA-approved. Removed from Category 2 on April 15, 2026. PCAC review...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Banned in horse racing. Not TGA-approved for human use.
TB-500 Fragment 17-23
TeduglutideFDA-approved. Gattex approved December 2012 for SBS in adults; expanded to...Health Canada approved (Revestive).MHRA approved (Revestive). NICE evaluated with restricted recommendation based...EMA-approved (Revestive, 2012). Approved for SBS in adults and children 1 year...TGA-approved (Revestive).
TeriparatideFDA-approved. Forteo approved November 2002 for postmenopausal osteoporosis,...Health Canada approved (Forteo).MHRA approved. NICE recommended for severe osteoporosis with fracture history.EMA-approved (Forsteo, 2003). Generic/biosimilar products available (Movymia,...TGA-approved (Forteo). PBS-listed with restrictions.
TerlipressinFDA-approved (Terlivaz) September 2022 for hepatorenal syndrome type 1. Boxed...Not approved by Health Canada as of 2025.MHRA approved (Glypressin). Used for variceal bleeding and hepatorenal syndrome.Approved in multiple EU member states for esophageal variceal hemorrhage and...TGA-approved (Glypressin) for esophageal variceal bleeding.
TesamorelinFDA-approved: Egrifta SV (Oct 2019) and Egrifta WR (March 2025) for...Approved by Health Canada. Manufactured by Theratechnologies Inc. in Montreal.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
TesofensineNot FDA-approved. Phase 3 trials ongoing under Saniona.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved. Development ongoing.Not TGA-approved.
TestagenResearch peptide. Not FDA-approved.
Thymagen
ThymalinNot FDA-approved. Available as research peptide.
ThymogenNot FDA-approved. Not recognized as a therapeutic agent.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
Thymosin Alpha-1Not FDA-approved. FDA orphan drug designation for hepatitis B. Available...Not approved by Health Canada.Not MHRA-approved.Not EMA centrally approved. Available in some EU member states.Not TGA-approved.
Thymosin Beta-4Not FDA-approved. RGN-259 has FDA Fast Track designation for neurotrophic...Not approved by Health Canada.Not MHRA-approved.Not EMA-approved. RGN-259 has EMA Orphan Drug Designation for neurotrophic...Not TGA-approved.
ThymulinNot FDA-approved. Research-use only. Not available as a pharmaceutical product.Not approved by Health Canada.Not approved by MHRA.Not EMA-approved. Investigated in academic research settings.Not TGA-approved. Not available as a therapeutic product.
TirzepatideFDA-approved: Mounjaro (T2D, adults and children 10+) and Zepbound...Health Canada approved (Mounjaro).MHRA/NICE approved (Mounjaro).EMA-approved (Mounjaro).TGA-approved (Mounjaro).
TrevogrumabNot FDA-approved. Phase 2-3 trials ongoing (Regeneron).Not approved.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
TRH (Thyrotropin-Releasing Hormone)
Tripeptide-29Cosmetic ingredient. Not FDA-regulated as a drug.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.Cosmetic ingredient.
TriptorelinFDA-approved. Trelstar (3.75 mg monthly, 11.25 mg q3mo, 22.5 mg q6mo) for...Health Canada approved (Trelstar, Decapeptyl).MHRA approved (Decapeptyl, Decapeptyl SR). Used for prostate cancer,...EMA-approved in member states (Decapeptyl). Additional indications include...TGA-approved (Diphereline). PBS-listed for prostate cancer.
UroguanylinUroguanylin itself is not FDA-approved. Related GC-C agonists linaclotide...Linaclotide approved by Health Canada. Uroguanylin not approved.Linaclotide available via MHRA. Uroguanylin not approved.Linaclotide EMA-approved (Constella). Uroguanylin not approved.Linaclotide TGA-approved. Uroguanylin not approved.
VasopressinFDA-approved (Vasostrict) for vasodilatory shock in adults. Also available as...Health Canada approved for vasodilatory shock and diabetes insipidus.Available for specialist use in vasodilatory shock and diabetes insipidus.Available in member states for vasodilatory shock and related indications.TGA-approved. Available for specialist hospital use.
VesiluteResearch peptide. Not FDA-approved.
Vesugen
Vialox (Pentapeptide-3)
VilonResearch peptide. Not FDA-approved.
VIP (Vasoactive Intestinal Peptide)Not FDA-approved. Aviptadil (RLF-100) EUA for COVID-19 ARDS was not granted....Not approved by Health Canada.Not approved by MHRA.Not EMA-approved. VIP analogs investigated in academic research.Not TGA-approved.
ZhenolutenNot FDA-approved. Not recognized as a therapeutic or supplement.Not approved by Health Canada.Not MHRA-approved.Not EMA-approved.Not TGA-approved.
ZiconotideFDA-approved (Prialt, December 2004) for severe chronic pain via intrathecal...Health Canada approved (Prialt).MHRA approved (Prialt) for severe chronic pain.EMA-approved (Prialt, February 2005) for severe chronic pain.TGA-approved (Prialt).

Showing 234 of 234 peptides with regulatory data

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This information is provided for educational and research reference only. Regulatory landscapes change frequently — always verify current status with the relevant national authority before making purchasing or research decisions. Volta Peptides sells all products exclusively for in vitro research use. Nothing on this page constitutes legal advice or a recommendation for human use. Consult a qualified legal or medical professional for guidance specific to your jurisdiction.

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