Regulatory

Are Peptides Legal in Australia? TGA Status

Therapeutic Goods Administration (TGA). 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, 12 are approved medicines in Australia, 9 are prescription only or otherwise restricted, 11 are investigational (in clinical trials, not approved), and 24 have an unclear or unlisted status. A peptide is a legal medicine in Australia only where it holds approval or authorisation for use there; the rest are not approved medicines.

How Australia regulates peptides

In Australia, peptides are regulated as therapeutic goods by the Therapeutic Goods Administration (TGA). A peptide may be supplied as a medicine only if it is entered on the Australian Register of Therapeutic Goods (ARTG), and most peptides are not on the ARTG.

Many peptides are captured as Schedule 4 (prescription only) substances under the Poisons Standard, meaning they may lawfully be supplied only on a prescription. BPC-157, for example, became a Schedule 4 substance with effect from 1 June 2024. Individuals may access some unapproved medicines through supervised pathways such as the Special Access Scheme or personal importation.

The status shown for each compound below reflects its recorded TGA standing. Open any profile for the specific, cited regulatory sources.

Official source: TGA (tga.gov.au)

Status in Australia (TGA) 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.

Status keyApprovedInvestigationalRestricted / Rx-onlyProhibitedUnclear
  • Abaloparatide

    Synthetic parathyroid hormone-related protein (PTHrP 1-34) analog; osteoanabolic agent

    Approved

    Registered on the ARTG as a prescription medicine (Eladynos, sponsor Theramex Australia) for postmenopausal osteoporosis, November 2024.

  • Afamelanotide

    Synthetic linear analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-1 receptor (MC1R) agonist ([Nle4-D-Phe7]-alpha-MSH, NDP-MSH)

    Approved

    Approved by the TGA and registered on the Australian Register of Therapeutic Goods (ARTG) in November 2020 as Scenesse (afamelanotide) implant for the prevention of phototoxicity in adults with erythropoietic protoporphyria; sponsored by the Australian company Clinuvel Pharmaceuticals.

  • Desmopressin

    Synthetic vasopressin V2-receptor agonist analog (1-deamino-8-D-arginine vasopressin)

    Approved

    Registered on the ARTG (Minirin and other brands; tablet, nasal spray, sublingual wafer, and injection) for indications including diabetes insipidus and nocturnal enuresis; prescription medicine.

  • Dulaglutide

    Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 analogue fused to a modified human IgG4 Fc fragment)

    Approved

    Registered on the ARTG (Trulicity) for type 2 diabetes, available on prescription.

  • Exenatide

    Glucagon-like peptide-1 (GLP-1) receptor agonist; synthetic exendin-4

    Approved

    Registered on the ARTG for type 2 diabetes, available on prescription.

  • GHK-Cu

    Copper-binding tripeptide (glycyl-L-histidyl-L-lysine complexed with Cu2+); endogenous matrikine; cosmetic ingredient name Copper Tripeptide-1

    Approved

    Permitted topically as a cosmetic ingredient; no approved medicinal (e.g., injectable) product.

  • Lanreotide

    Long-acting synthetic somatostatin analog (cyclic octapeptide)

    Approved

    Registered on the ARTG as a prescription medicine (Somatuline Autogel, sponsor Ipsen), since September 2003.

  • Linaclotide

    Guanylate cyclase-C (GC-C) agonist peptide (14 amino acids)

    Approved

    Registered on the ARTG as Constella (linaclotide) for adults with IBS-C and chronic idiopathic constipation; prescription medicine.

  • Liraglutide

    Glucagon-like peptide-1 (GLP-1) receptor agonist (acylated GLP-1 analogue)

    Approved

    Registered on the ARTG: Victoza for type 2 diabetes and Saxenda for weight management, available on prescription.

  • Octreotide

    Synthetic somatostatin analog (octapeptide); inhibitor of growth hormone and gastroenteropancreatic hormone secretion

    Approved

    Registered on the ARTG as a prescription medicine (Sandostatin and Sandostatin LAR).

  • Teduglutide

    Recombinant glucagon-like peptide-2 (GLP-2) analog

    Approved

    Registered on the ARTG as Revestive (ARTG 274911) since May 2017 for adults with short bowel syndrome dependent on parenteral support; prescription medicine.

  • Teriparatide

    Recombinant human parathyroid hormone fragment PTH(1-34); bone-forming (anabolic) osteoporosis agent

    Approved

    Registered on the ARTG (Forteo, ARTG 80333) as a prescription medicine; teriparatide biosimilars such as Terrosa are also registered.

  • Cagrilintide

    Long-acting amylin (and calcitonin) receptor agonist / amylin analogue

    Investigational

    Not entered on the ARTG; investigational only and not approved for supply.

  • Elamipretide

    Mitochondria-targeted tetrapeptide (cardiolipin-binding Szeto-Schiller peptide)

    Investigational

    Not on the ARTG; investigational only and not approved for supply.

  • Follistatin

    Endogenous activin-binding glycoprotein; myostatin/activin antagonist (studied as recombinant protein and via gene therapy, e.g., FS-344)

    Investigational

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.

  • GHRP-2

    Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP)

    Investigational

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered product.

  • GHRP-6

    Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; first-described growth hormone-releasing hexapeptide (His-D-Trp-Ala-Trp-D-Phe-Lys)

    Investigational

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered product.

  • Hexarelin

    Synthetic growth hormone secretagogue; ghrelin receptor (GHS-R1a) agonist; growth hormone-releasing peptide (GHRP) hexapeptide

    Investigational

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered product.

  • Kisspeptin

    Reproductive neuropeptide; KISS1 gene product and endogenous agonist of the kisspeptin receptor (KISS1R/GPR54); upstream stimulator of GnRH neurons

    Investigational

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.

  • Mazdutide

    Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors; a synthetic oxyntomodulin analogue

    Investigational

    Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.

  • Orforglipron

    Oral small-molecule (non-peptide) agonist of the glucagon-like peptide-1 (GLP-1) receptor

    Investigational

    Not entered on the Australian Register of Therapeutic Goods (ARTG); not yet approved for supply.

  • Retatrutide

    Triple agonist of the GIP, GLP-1, and glucagon receptors (investigational incretin/metabolic peptide)

    Investigational

    Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.

  • Survodutide

    Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors (investigational metabolic peptide)

    Investigational

    Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.

  • AOD-9604

    Modified C-terminal fragment of human growth hormone (tyrosine-modified hGH 176-191); lipolytic peptide

    Restricted / Rx-only

    Not approved for therapeutic use; the obesity indication was not approved. When supplied for therapeutic use it is a prescription-only (Schedule 4) substance; it is not an approved medicine on the ARTG.

  • BPC-157

    Synthetic stable gastric pentadecapeptide (15-amino-acid partial sequence derived from a protein in human gastric juice)

    Restricted / Rx-only

    Schedule 4 (Prescription Only Medicine) under the Poisons Standard (added to Schedule 4 effective 1 June 2024); no registered product, prescription/compounded supply only.

  • CJC-1295

    Growth hormone-releasing hormone (GHRH) analog

    Restricted / Rx-only

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved GHRH analog. Supply for human therapeutic use is restricted (prescription-only class of substance) and no obesity/GH indication is approved.

  • Ipamorelin

    Growth hormone secretagogue; ghrelin (GHS-R1a) receptor agonist (pentapeptide)

    Restricted / Rx-only

    Not on the ARTG; an unapproved growth hormone secretagogue. Supply for human therapeutic use is restricted (prescription-only class) with no approved indication.

  • Lixisenatide

    Short-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-4 based incretin mimetic)

    Restricted / Rx-only

    Registered on the ARTG as Lyxumia in 2013 as a prescription-only medicine. Sanofi cancelled the standalone Lyxumia ARTG entry in February 2021.

  • Melanotan II

    Synthetic cyclic analogue of alpha-melanocyte-stimulating hormone (alpha-MSH); non-selective melanocortin receptor agonist

    Restricted / Rx-only

    Not on the Australian Register of Therapeutic Goods (ARTG); melanotan I and II are unapproved substances, and the TGA has warned consumers against unapproved injectable tanning products. Supply for therapeutic use falls in the prescription-only class.

  • Semaglutide

    Glucagon-like peptide-1 (GLP-1) receptor agonist

    Restricted / Rx-only

    Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.

  • Setmelanotide

    Melanocortin-4 receptor (MC4R) agonist

    Restricted / Rx-only

    Not registered on the Australian Register of Therapeutic Goods (ARTG). Any access in Australia would be through unapproved-goods pathways such as the Special Access Scheme.

  • Tirzepatide

    Dual agonist of the GIP and GLP-1 receptors (incretin-based metabolic peptide)

    Restricted / Rx-only

    Registered on the ARTG (Mounjaro) for type 2 diabetes and for weight management, available on prescription.

  • Amycretin

    Unimolecular GLP-1 and amylin receptor co-agonist

    Unclear

    Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.

  • Argireline

    Topical cosmetic peptide (Acetyl Hexapeptide-8); SNAP-25 N-terminal fragment mimetic

    Unclear

    Permitted in topical cosmetics as a cosmetic ingredient; not an approved therapeutic (medicinal) product.

  • Dihexa

    Angiotensin IV-derived peptide (metabolically stabilised); investigational nootropic / HGF-Met modulator

    Unclear

    Not on the ARTG; an unapproved experimental substance.

  • DSIP

    Delta sleep-inducing peptide; endogenous neuromodulatory nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu)

    Unclear

    Not on the ARTG; an unapproved experimental substance.

  • Efpeglenatide

    Long-acting glucagon-like peptide-1 (GLP-1) receptor agonist (exendin-based, once-weekly)

    Unclear

    Not registered on the ARTG. Investigational only.

  • Epithalon

    Synthetic pineal tetrapeptide bioregulator (Ala-Glu-Asp-Gly / AEDG); studied as a telomerase-related peptide

    Unclear

    Not approved by the TGA and not entered on the Australian Register of Therapeutic Goods (ARTG); no registered therapeutic product.

  • FOXO4-DRI

    Senolytic peptide (FOXO4 D-retro-inverso peptide); disrupts the FOXO4-p53 interaction

    Unclear

    Not on the ARTG; an unapproved experimental substance.

  • Gonadorelin

    Synthetic gonadotropin-releasing hormone (GnRH/LHRH); decapeptide identical to endogenous GnRH; GnRH receptor agonist

    Unclear

    Gonadorelin (native GnRH) has been used clinically in Australia for diagnostic and fertility indications; its current ARTG registration should be verified. Related GnRH analogues (e.g., leuprorelin, goserelin) are registered.

  • Humanin

    Mitochondrial-derived peptide (24-residue; encoded in the mtDNA 16S rRNA region); cytoprotective

    Unclear

    Not on the ARTG; an unapproved experimental substance.

  • 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

    Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.

  • KPV

    Tripeptide (Lys-Pro-Val); C-terminal fragment of alpha-melanocyte-stimulating hormone (alpha-MSH); melanocortin-derived anti-inflammatory peptide

    Unclear

    No registered/approved product; an unapproved therapeutic substance.

  • LL-37

    Human cathelicidin antimicrobial peptide (37-residue C-terminal fragment of hCAP18); host-defence peptide

    Unclear

    Not on the ARTG; no approved LL-37 product.

  • Maridebart cafraglutide

    Peptide-antibody conjugate with GLP-1 receptor agonist and GIP receptor antagonist activity

    Unclear

    Not registered on the Australian Register of Therapeutic Goods (ARTG). Investigational; not approved in Australia.

  • MOTS-c

    Mitochondrial-derived peptide (MDP); AMPK activator / exercise mimetic

    Unclear

    Not on the ARTG; an unapproved experimental substance with no approved indication.

  • Petrelintide

    Long-acting amylin (islet amyloid polypeptide) receptor agonist for weight management

    Unclear

    Not registered on the ARTG. Investigational only.

  • Pramlintide

    Synthetic amylin analog (amylinomimetic)

    Unclear

    Not registered on the Australian Register of Therapeutic Goods (ARTG); pramlintide is not marketed as a registered medicine in Australia.

  • PT-141 (Bremelanotide)

    Melanocortin receptor agonist; synthetic cyclic analog of alpha-melanocyte-stimulating hormone (alpha-MSH)

    Unclear

    Not registered on the ARTG; no approved bremelanotide/Vyleesi product in Australia. Compounded or imported PT-141 is unapproved.

  • Selank

    Synthetic tuftsin analog (heptapeptide, Thr-Lys-Pro-Arg-Pro-Gly-Pro); anxiolytic/nootropic neuropeptide

    Unclear

    Not approved by the TGA and not on the ARTG; no registered therapeutic product.

  • Semax

    Synthetic ACTH(4-10) analog (heptapeptide, Met-Glu-His-Phe-Pro-Gly-Pro); nootropic/neuroprotective neuropeptide

    Unclear

    Not approved by the TGA and not on the ARTG; no registered therapeutic product.

  • 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

    Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved sermorelin product. Supply for human therapeutic use would be prescription-only or via compounding.

  • 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 registered/approved product; an unapproved therapeutic substance.

  • Tesamorelin

    Synthetic analogue of growth hormone-releasing hormone (GHRH); approved for HIV-associated lipodystrophy

    Unclear

    Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved tesamorelin product in Australia.

  • Thymalin

    Thymic polypeptide preparation (calf-thymus extract); immunomodulatory bioregulator

    Unclear

    Not on the ARTG; an unapproved substance in Australia.

  • Thymosin Alpha-1

    Synthetic 28-amino-acid thymic peptide (thymalfasin); immunomodulator

    Unclear

    Not entered on the Australian Register of Therapeutic Goods (ARTG); no approved thymalfasin product in Australia.

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 Australia?
It depends on the specific peptide. A peptide is a legal medicine in Australia only where it holds approval or authorisation for use there. Of the 56 peptides tracked here, 12 are recorded as approved, 9 as prescription only or restricted, and 11 as investigational; the remaining 24 have an unclear or unlisted status. Unapproved peptides are not legal medicines.
Which peptides are approved for use in Australia?
The following peptides tracked here are recorded as approved or authorised in Australia: Abaloparatide, Afamelanotide, Desmopressin, Dulaglutide, Exenatide, GHK-Cu, Lanreotide, Linaclotide, Liraglutide, Octreotide, Teduglutide, Teriparatide. Any tracked peptide not listed here does not have a recorded status of approved in Australia.

Peptide status in other jurisdictions