Are Peptides Legal in the European Union? EMA Status
European Medicines Agency (EMA). 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, 16 are approved medicines in the European Union, 2 are prescription only or otherwise restricted, 11 are investigational (in clinical trials, not approved), and 27 have an unclear or unlisted status. A peptide is a legal medicine in the European Union only where it holds approval or authorisation for use there; the rest are not approved medicines.
How the European Union regulates peptides
In the European Union, medicines are authorised through a system coordinated by the European Medicines Agency (EMA), frequently via the centralised procedure that grants a single marketing authorisation valid across member states. A peptide is a legal medicine in the EU only where it holds such an authorisation.
Peptides without an authorisation are not approved medicines in the EU. National authorities in each member state enforce the rules, so availability and enforcement can differ from one country to another.
The status shown for each compound below reflects its recorded EMA or EU standing. Open any profile for the specific, cited regulatory sources.
Status in the European Union (EMA) 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
Authorised across the EU (Eladynos) for postmenopausal osteoporosis, December 2022, following an earlier 2018 refusal.
- AfamelanotideApproved
Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH)
Authorised in 2014 as Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria.
- DesmopressinApproved
Synthetic vasopressin V2-receptor agonist analog (1-deamino-8-D-arginine vasopressin)
Authorized nationally across EU member states (not via a centralized EMA marketing authorisation).
- DulaglutideApproved
Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 analogue fused to a modified human IgG4 Fc fragment)
Authorized (Trulicity) for type 2 diabetes (marketing authorization granted 2014).
- ExenatideApproved
Glucagon-like peptide-1 (GLP-1) receptor agonist; synthetic exendin-4
Authorized: Byetta (2006) and Bydureon (2011) for type 2 diabetes.
- GHK-CuApproved
Copper-binding tripeptide (glycyl-L-histidyl-L-lysine complexed with Cu2+); endogenous matrikine; cosmetic ingredient name Copper Tripeptide-1
Permitted cosmetic ingredient (INCI: Copper Tripeptide-1); no medicinal marketing authorisation.
- GonadorelinApproved
Synthetic gonadotropin-releasing hormone (GnRH/LHRH); decapeptide identical to endogenous GnRH; GnRH receptor agonist
Gonadorelin has been marketed in European countries through national approvals (as a diagnostic agent and for pulsatile fertility therapy) rather than through a single centralised EMA authorisation.
- LanreotideApproved
Long-acting synthetic somatostatin analog (cyclic octapeptide)
Authorised and marketed in EU member states (nationally authorised; brand Somatuline Autogel).
- LinaclotideApproved
Guanylate cyclase-C (GC-C) agonist peptide (14 amino acids)
Authorized. Constella (linaclotide) received an EU-wide marketing authorisation in November 2012 for irritable bowel syndrome with constipation in adults.
- LiraglutideApproved
Glucagon-like peptide-1 (GLP-1) receptor agonist (acylated GLP-1 analogue)
Authorized: Victoza (2009) for type 2 diabetes and Saxenda (2015) for weight management.
- OctreotideApproved
Synthetic somatostatin analog (octapeptide); inhibitor of growth hormone and gastroenteropancreatic hormone secretion
Authorised and marketed in EU member states (nationally authorised; brand Sandostatin).
- SemaglutideApproved
Glucagon-like peptide-1 (GLP-1) receptor agonist
Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management.
- SetmelanotideApproved
Melanocortin-4 receptor (MC4R) agonist
Authorized. Marketing authorisation valid throughout the EU since 16 July 2021 for weight management in patients 6 years and older with obesity due to POMC, PCSK1 or LEPR deficiency, and Bardet-Biedl syndrome.
- TeduglutideApproved
Recombinant glucagon-like peptide-2 (GLP-2) analog
Authorized. Revestive (teduglutide) received an EU-wide marketing authorisation in August 2012 for short bowel syndrome.
- TeriparatideApproved
Recombinant human parathyroid hormone fragment PTH(1-34); bone-forming (anabolic) osteoporosis agent
Authorised as Forsteo on 10 June 2003 (Eli Lilly Nederland B.V.) for osteoporosis in postmenopausal women, men at increased fracture risk, and glucocorticoid-induced osteoporosis. Teriparatide biosimilars are also authorised.
- TirzepatideApproved
Dual agonist of the GIP and GLP-1 receptors (incretin-based metabolic peptide)
Authorized (Mounjaro) for type 2 diabetes and weight management (marketing authorization granted September 2022).
- CagrilintideInvestigational
Long-acting amylin (and calcitonin) receptor agonist / amylin analogue
Not authorized; investigational, no marketing authorization.
- ElamipretideInvestigational
Mitochondria-targeted tetrapeptide (cardiolipin-binding Szeto-Schiller peptide)
No EMA marketing authorisation; not authorised as a medicine in the EU.
- FollistatinInvestigational
Endogenous activin-binding glycoprotein; myostatin/activin antagonist (studied as recombinant protein and via gene therapy, e.g., FS-344)
No EMA marketing authorisation; not an approved medicine in the EU.
- GHRP-2Investigational
Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP)
No EMA marketing authorisation; not an approved medicine in the EU.
- 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)
No EMA marketing authorisation; not an approved medicine in the EU.
- HexarelinInvestigational
Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) hexapeptide
No EMA marketing authorisation; not an approved medicine in the EU.
- KisspeptinInvestigational
Reproductive neuropeptide; KISS1 gene product and endogenous agonist of the kisspeptin receptor (KISS1R/GPR54); upstream stimulator of GnRH neurons
No EMA marketing authorisation; not an approved medicine in the EU.
- MazdutideInvestigational
Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors; a synthetic oxyntomodulin analogue
Not authorized; investigational, no marketing authorization.
- OrforglipronInvestigational
Oral small-molecule (non-peptide) agonist of the glucagon-like peptide-1 (GLP-1) receptor
Not authorized; no marketing authorization at this time.
- RetatrutideInvestigational
Triple agonist of the GIP, GLP-1, and glucagon receptors (investigational incretin/metabolic peptide)
Not authorized; investigational, no marketing authorization.
- SurvodutideInvestigational
Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors (investigational metabolic peptide)
Not authorized; investigational, no marketing authorization.
- LixisenatideRestricted / Rx-only
Short-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-4 based incretin mimetic)
Authorised as Lyxumia on 1 February 2013 for type 2 diabetes. The marketing authorisation was withdrawn on 18 December 2025 at Sanofi's request for commercial reasons. The insulin glargine combination Suliqua remains authorised.
- Melanotan IIRestricted / Rx-only
Synthetic cyclic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); non-selective melanocortin receptor agonist
No EU marketing authorisation. Melanotan II is an unlicensed product; European medicines regulators, including the UK's MHRA, have issued public safety warnings, and its sale is illegal in the UK.
- AmycretinUnclear
Unimolecular GLP-1 and amylin receptor co-agonist
Not authorized. Investigational; no EU marketing authorisation.
- AOD-9604Unclear
Modified C-terminal fragment of human growth hormone (tyrosine-modified hGH 176-191); lipolytic peptide
No EMA marketing authorization; not an approved medicine in the EU.
- ArgirelineUnclear
Topical cosmetic peptide (Acetyl Hexapeptide-8); SNAP-25 N-terminal fragment mimetic
Permitted as a cosmetic ingredient (INCI: Acetyl Hexapeptide-8) under EU cosmetics regulation; no medicinal marketing authorisation.
- BPC-157Unclear
Synthetic stable gastric pentadecapeptide (15-amino-acid partial sequence derived from a protein in human gastric juice)
No EMA marketing authorisation; not an approved medicine.
- CJC-1295Unclear
Growth hormone-releasing hormone (GHRH) analog
No EMA marketing authorization; not an approved medicine in the EU.
- DihexaUnclear
Angiotensin IV-derived peptide (metabolically stabilised); investigational nootropic / HGF-Met modulator
No EMA marketing authorisation; not an approved medicine in the EU.
- DSIPUnclear
Delta sleep-inducing peptide; endogenous neuromodulatory nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu)
No EMA marketing authorisation; not an approved medicine in the EU.
- EfpeglenatideUnclear
Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-based, once-weekly)
Not authorised. No EMA marketing authorization.
- EpithalonUnclear
Synthetic pineal tetrapeptide bioregulator (Ala-Glu-Asp-Gly / AEDG); studied as a telomerase-related peptide
No EMA marketing authorisation; not an approved medicine in the EU.
- FOXO4-DRIUnclear
Senolytic peptide (FOXO4 D-retro-inverso peptide); disrupts the FOXO4-p53 interaction
No EMA marketing authorisation; not an approved medicine in the EU.
- HumaninUnclear
Mitochondrial-derived peptide (24-residue; encoded in the mtDNA 16S rRNA region); cytoprotective
No EMA marketing authorisation; not an approved medicine in the EU.
- IGF-1 LR3Unclear
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
No EMA marketing authorisation; not an approved medicine in the EU.
- IpamorelinUnclear
Growth hormone secretagogue; ghrelin (GHS-R1a) receptor agonist (pentapeptide)
No EMA marketing authorization; not an approved medicine in the EU.
- KPVUnclear
Tripeptide (Lys-Pro-Val); C-terminal fragment of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-derived anti-inflammatory peptide
No EMA marketing authorisation.
- LL-37Unclear
Human cathelicidin antimicrobial peptide (37-residue C-terminal fragment of hCAP18); host-defence peptide
No EMA marketing authorisation; investigated only in early clinical studies (for example, wound healing).
- Maridebart cafraglutideUnclear
Peptide-antibody conjugate with GLP-1 receptor agonist and GIP receptor antagonist activity
Not authorized. Investigational; no EU marketing authorisation.
- MOTS-cUnclear
Mitochondrial-derived peptide (MDP); AMPK activator / exercise mimetic
No EMA marketing authorization; not an approved medicine in the EU.
- PetrelintideUnclear
Long-acting amylin (islet amyloid polypeptide) receptor agonist for weight management
Not authorised. Investigational only.
- PramlintideUnclear
Synthetic amylin analog (amylinomimetic)
Not authorized. Pramlintide does not hold an EMA marketing authorisation and is not marketed in the European Union.
- PT-141 (Bremelanotide)Unclear
Melanocortin receptor agonist; synthetic cyclic analog of alpha-melanocyte-stimulating hormone (alpha-MSH)
No EMA marketing authorisation; not an approved medicine in the EU (European commercialisation rights licensed to Gedeon Richter were terminated in 2016 and no EU approval followed).
- SelankUnclear
Synthetic tuftsin analog (heptapeptide, Thr-Lys-Pro-Arg-Pro-Gly-Pro); anxiolytic/nootropic neuropeptide
No EMA marketing authorisation; not an approved medicine in the EU.
- SemaxUnclear
Synthetic ACTH(4-10) analog (heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro); nootropic/neuroprotective neuropeptide
No EMA marketing authorisation; not an approved medicine in the EU.
- 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
No current EMA marketing authorisation; not an approved medicine in the European Union.
- TB-500Unclear
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
No EMA marketing authorisation.
- TesamorelinUnclear
Synthetic analogue of growth hormone-releasing hormone (GHRH); approved for HIV-associated lipodystrophy
No EMA marketing authorisation; tesamorelin is not an approved medicine in the European Union.
- ThymalinUnclear
Thymic polypeptide preparation (calf-thymus extract); immunomodulatory bioregulator
No EMA marketing authorisation; not an approved medicine in the EU.
- Thymosin Alpha-1Unclear
Synthetic 28-amino-acid thymic peptide (thymalfasin); immunomodulator
No EMA centralized marketing authorisation; not authorised as a medicine at the EU level.
| Compound | Tone | Status in the European Union (EMA) |
|---|---|---|
| Abaloparatide Synthetic parathyroid hormone-related protein (PTHrP 1-34) analog; osteoanabolic agent | Approved | Authorised across the EU (Eladynos) for postmenopausal osteoporosis, December 2022, following an earlier 2018 refusal. |
| Afamelanotide Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH) | Approved | Authorised in 2014 as Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria. |
| Desmopressin Synthetic vasopressin V2-receptor agonist analog (1-deamino-8-D-arginine vasopressin) | Approved | Authorized nationally across EU member states (not via a centralized EMA marketing authorisation). |
| Dulaglutide Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 analogue fused to a modified human IgG4 Fc fragment) | Approved | Authorized (Trulicity) for type 2 diabetes (marketing authorization granted 2014). |
| Exenatide Glucagon-like peptide-1 (GLP-1) receptor agonist; synthetic exendin-4 | Approved | Authorized: Byetta (2006) and Bydureon (2011) for type 2 diabetes. |
| GHK-Cu Copper-binding tripeptide (glycyl-L-histidyl-L-lysine complexed with Cu2+); endogenous matrikine; cosmetic ingredient name Copper Tripeptide-1 | Approved | Permitted cosmetic ingredient (INCI: Copper Tripeptide-1); no medicinal marketing authorisation. |
| Gonadorelin Synthetic gonadotropin-releasing hormone (GnRH/LHRH); decapeptide identical to endogenous GnRH; GnRH receptor agonist | Approved | Gonadorelin has been marketed in European countries through national approvals (as a diagnostic agent and for pulsatile fertility therapy) rather than through a single centralised EMA authorisation. |
| Lanreotide Long-acting synthetic somatostatin analog (cyclic octapeptide) | Approved | Authorised and marketed in EU member states (nationally authorised; brand Somatuline Autogel). |
| Linaclotide Guanylate cyclase-C (GC-C) agonist peptide (14 amino acids) | Approved | Authorized. Constella (linaclotide) received an EU-wide marketing authorisation in November 2012 for irritable bowel syndrome with constipation in adults. |
| Liraglutide Glucagon-like peptide-1 (GLP-1) receptor agonist (acylated GLP-1 analogue) | Approved | Authorized: Victoza (2009) for type 2 diabetes and Saxenda (2015) for weight management. |
| Octreotide Synthetic somatostatin analog (octapeptide); inhibitor of growth hormone and gastroenteropancreatic hormone secretion | Approved | Authorised and marketed in EU member states (nationally authorised; brand Sandostatin). |
| Semaglutide Glucagon-like peptide-1 (GLP-1) receptor agonist | Approved | Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management. |
| Setmelanotide Melanocortin-4 receptor (MC4R) agonist | Approved | Authorized. Marketing authorisation valid throughout the EU since 16 July 2021 for weight management in patients 6 years and older with obesity due to POMC, PCSK1 or LEPR deficiency, and Bardet-Biedl syndrome. |
| Teduglutide Recombinant glucagon-like peptide-2 (GLP-2) analog | Approved | Authorized. Revestive (teduglutide) received an EU-wide marketing authorisation in August 2012 for short bowel syndrome. |
| Teriparatide Recombinant human parathyroid hormone fragment PTH(1-34); bone-forming (anabolic) osteoporosis agent | Approved | Authorised as Forsteo on 10 June 2003 (Eli Lilly Nederland B.V.) for osteoporosis in postmenopausal women, men at increased fracture risk, and glucocorticoid-induced osteoporosis. Teriparatide biosimilars are also authorised. |
| Tirzepatide Dual agonist of the GIP and GLP-1 receptors (incretin-based metabolic peptide) | Approved | Authorized (Mounjaro) for type 2 diabetes and weight management (marketing authorization granted September 2022). |
| Cagrilintide Long-acting amylin (and calcitonin) receptor agonist / amylin analogue | Investigational | Not authorized; investigational, no marketing authorization. |
| Elamipretide Mitochondria-targeted tetrapeptide (cardiolipin-binding Szeto-Schiller peptide) | Investigational | No EMA marketing authorisation; not authorised as a medicine in the EU. |
| Follistatin Endogenous activin-binding glycoprotein; myostatin/activin antagonist (studied as recombinant protein and via gene therapy, e.g., FS-344) | Investigational | No EMA marketing authorisation; not an approved medicine in the EU. |
| GHRP-2 Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) | Investigational | No EMA marketing authorisation; not an approved medicine in the EU. |
| 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 | No EMA marketing authorisation; not an approved medicine in the EU. |
| Hexarelin Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) hexapeptide | Investigational | No EMA marketing authorisation; not an approved medicine in the EU. |
| Kisspeptin Reproductive neuropeptide; KISS1 gene product and endogenous agonist of the kisspeptin receptor (KISS1R/GPR54); upstream stimulator of GnRH neurons | Investigational | No EMA marketing authorisation; not an approved medicine in the EU. |
| Mazdutide Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors; a synthetic oxyntomodulin analogue | Investigational | Not authorized; investigational, no marketing authorization. |
| Orforglipron Oral small-molecule (non-peptide) agonist of the glucagon-like peptide-1 (GLP-1) receptor | Investigational | Not authorized; no marketing authorization at this time. |
| Retatrutide Triple agonist of the GIP, GLP-1, and glucagon receptors (investigational incretin/metabolic peptide) | Investigational | Not authorized; investigational, no marketing authorization. |
| Survodutide Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors (investigational metabolic peptide) | Investigational | Not authorized; investigational, no marketing authorization. |
| Lixisenatide Short-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-4 based incretin mimetic) | Restricted / Rx-only | Authorised as Lyxumia on 1 February 2013 for type 2 diabetes. The marketing authorisation was withdrawn on 18 December 2025 at Sanofi's request for commercial reasons. The insulin glargine combination Suliqua remains authorised. |
| Melanotan II Synthetic cyclic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); non-selective melanocortin receptor agonist | Restricted / Rx-only | No EU marketing authorisation. Melanotan II is an unlicensed product; European medicines regulators, including the UK's MHRA, have issued public safety warnings, and its sale is illegal in the UK. |
| Amycretin Unimolecular GLP-1 and amylin receptor co-agonist | Unclear | Not authorized. Investigational; no EU marketing authorisation. |
| AOD-9604 Modified C-terminal fragment of human growth hormone (tyrosine-modified hGH 176-191); lipolytic peptide | Unclear | No EMA marketing authorization; not an approved medicine in the EU. |
| Argireline Topical cosmetic peptide (Acetyl Hexapeptide-8); SNAP-25 N-terminal fragment mimetic | Unclear | Permitted as a cosmetic ingredient (INCI: Acetyl Hexapeptide-8) under EU cosmetics regulation; no medicinal marketing authorisation. |
| BPC-157 Synthetic stable gastric pentadecapeptide (15-amino-acid partial sequence derived from a protein in human gastric juice) | Unclear | No EMA marketing authorisation; not an approved medicine. |
| CJC-1295 Growth hormone-releasing hormone (GHRH) analog | Unclear | No EMA marketing authorization; not an approved medicine in the EU. |
| Dihexa Angiotensin IV-derived peptide (metabolically stabilised); investigational nootropic / HGF-Met modulator | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| DSIP Delta sleep-inducing peptide; endogenous neuromodulatory nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu) | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| Efpeglenatide Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-based, once-weekly) | Unclear | Not authorised. No EMA marketing authorization. |
| Epithalon Synthetic pineal tetrapeptide bioregulator (Ala-Glu-Asp-Gly / AEDG); studied as a telomerase-related peptide | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| FOXO4-DRI Senolytic peptide (FOXO4 D-retro-inverso peptide); disrupts the FOXO4-p53 interaction | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| Humanin Mitochondrial-derived peptide (24-residue; encoded in the mtDNA 16S rRNA region); cytoprotective | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| 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 | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| Ipamorelin Growth hormone secretagogue; ghrelin (GHS-R1a) receptor agonist (pentapeptide) | Unclear | No EMA marketing authorization; not an approved medicine in the EU. |
| KPV Tripeptide (Lys-Pro-Val); C-terminal fragment of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-derived anti-inflammatory peptide | Unclear | No EMA marketing authorisation. |
| LL-37 Human cathelicidin antimicrobial peptide (37-residue C-terminal fragment of hCAP18); host-defence peptide | Unclear | No EMA marketing authorisation; investigated only in early clinical studies (for example, wound healing). |
| Maridebart cafraglutide Peptide-antibody conjugate with GLP-1 receptor agonist and GIP receptor antagonist activity | Unclear | Not authorized. Investigational; no EU marketing authorisation. |
| MOTS-c Mitochondrial-derived peptide (MDP); AMPK activator / exercise mimetic | Unclear | No EMA marketing authorization; not an approved medicine in the EU. |
| Petrelintide Long-acting amylin (islet amyloid polypeptide) receptor agonist for weight management | Unclear | Not authorised. Investigational only. |
| Pramlintide Synthetic amylin analog (amylinomimetic) | Unclear | Not authorized. Pramlintide does not hold an EMA marketing authorisation and is not marketed in the European Union. |
| PT-141 (Bremelanotide) Melanocortin receptor agonist; synthetic cyclic analog of alpha-melanocyte-stimulating hormone (alpha-MSH) | Unclear | No EMA marketing authorisation; not an approved medicine in the EU (European commercialisation rights licensed to Gedeon Richter were terminated in 2016 and no EU approval followed). |
| Selank Synthetic tuftsin analog (heptapeptide, Thr-Lys-Pro-Arg-Pro-Gly-Pro); anxiolytic/nootropic neuropeptide | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| Semax Synthetic ACTH(4-10) analog (heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro); nootropic/neuroprotective neuropeptide | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| 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 | No current EMA marketing authorisation; not an approved medicine in the European Union. |
| 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 | Unclear | No EMA marketing authorisation. |
| Tesamorelin Synthetic analogue of growth hormone-releasing hormone (GHRH); approved for HIV-associated lipodystrophy | Unclear | No EMA marketing authorisation; tesamorelin is not an approved medicine in the European Union. |
| Thymalin Thymic polypeptide preparation (calf-thymus extract); immunomodulatory bioregulator | Unclear | No EMA marketing authorisation; not an approved medicine in the EU. |
| Thymosin Alpha-1 Synthetic 28-amino-acid thymic peptide (thymalfasin); immunomodulator | Unclear | No EMA centralized marketing authorisation; not authorised as a medicine at the EU level. |
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 European Union?
- It depends on the specific peptide. A peptide is a legal medicine in the European Union only where it holds approval or authorisation for use there. Of the 56 peptides tracked here, 16 are recorded as approved, 2 as prescription only or restricted, and 11 as investigational; the remaining 27 have an unclear or unlisted status. Unapproved peptides are not legal medicines.
- Which peptides are approved for use in the European Union?
- The following peptides tracked here are recorded as approved or authorised in the European Union: Abaloparatide, Afamelanotide, Desmopressin, Dulaglutide, Exenatide, GHK-Cu, Gonadorelin, Lanreotide, Linaclotide, Liraglutide, Octreotide, Semaglutide, Setmelanotide, Teduglutide, Teriparatide, Tirzepatide. Any tracked peptide not listed here does not have a recorded status of approved in the European Union.