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Regulatory

Regulatory Watch

Regulatory status of peptide compounds across the FDA, TGA, EMA, and WADA, with coverage of approvals, scheduling decisions, and guidance from the authorities governing peptide therapeutics.

Regulatory coverage

Recent reporting on approvals, regulatory filings, and scheduling decisions affecting peptide compounds.

Regulatory status by compound

How each tracked peptide is classified by major regulators and anti-doping authorities. Colored dots indicate the regulatory tone of an entry; the text states its specific status.

Status keyApprovedInvestigationalRestricted / Rx-onlyProhibitedUnclear
Regulatory status of tracked peptide compounds by region. Colored dots indicate the regulatory tone of each entry; the adjacent text states the specific status.
CompoundOverall statusStatus by region
Tirzepatide

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

Approved
  • United States (FDA) Approved. Mounjaro for type 2 diabetes (May 2022); Zepbound for chronic weight management (November 2023) and for moderate-to-severe obstructive sleep apnea in adults with obesity (December 2024).
  • Australia (TGA) Registered on the ARTG (Mounjaro) for type 2 diabetes and for weight management, available on prescription.
  • European Union (EMA) Authorized (Mounjaro) for type 2 diabetes and weight management (marketing authorization granted September 2022).
  • WADA Not prohibited. Added to the WADA 2026 Monitoring Program, with markers tracked in- and out-of-competition to detect patterns of misuse; not a banned substance.
Semaglutide

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

Approved
  • United States (FDA) Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025.
  • Australia (TGA) Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
  • European Union (EMA) Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management.
  • WADA Not prohibited. On the WADA Monitoring Program (introduced 2024, continued into 2026); it is tracked but not a banned substance.
PT-141 (Bremelanotide)

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

Approved
  • United States (FDA) Approved June 21, 2019 as Vyleesi (bremelanotide) for acquired, generalized HSDD in premenopausal women; prescription medicine.
  • Australia (TGA) Not registered on the ARTG; no approved bremelanotide/Vyleesi product in Australia. Compounded or imported PT-141 is unapproved.
  • European Union (EMA) 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).
  • WADA Not specifically named on the WADA Prohibited List. As an approved medicine it is not captured by the S0 non-approved-substances clause, and it does not fall within a listed prohibited class; athletes should nonetheless verify current status.
Liraglutide

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

Approved
  • United States (FDA) Approved. Victoza for type 2 diabetes (2010), with a cardiovascular risk reduction indication added in 2017; Saxenda (liraglutide 3.0 mg) for chronic weight management (2014), later extended to adolescents aged 12 to 17 with obesity (2020).
  • Australia (TGA) Registered on the ARTG: Victoza for type 2 diabetes and Saxenda for weight management, available on prescription.
  • European Union (EMA) Authorized: Victoza (2009) for type 2 diabetes and Saxenda (2015) for weight management.
  • WADA Not prohibited. GLP-1 receptor agonists are not on the WADA Prohibited List and are not banned substances; the class is tracked under WADA's monitoring program rather than prohibited.
Dulaglutide

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

Approved
  • United States (FDA) Approved. Trulicity for type 2 diabetes (2014); an indication to reduce major adverse cardiovascular events in adults with type 2 diabetes was added in 2020.
  • Australia (TGA) Registered on the ARTG (Trulicity) for type 2 diabetes, available on prescription.
  • European Union (EMA) Authorized (Trulicity) for type 2 diabetes (marketing authorization granted 2014).
  • WADA Not prohibited. GLP-1 receptor agonists are not on the WADA Prohibited List and are not banned substances; the class is tracked under WADA's monitoring program rather than prohibited.
Exenatide

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

Approved
  • United States (FDA) Approved. Byetta (exenatide twice daily) for type 2 diabetes (2005), the first GLP-1 receptor agonist approved, and Bydureon (extended-release, once weekly) (2012).
  • Australia (TGA) Registered on the ARTG for type 2 diabetes, available on prescription.
  • European Union (EMA) Authorized: Byetta (2006) and Bydureon (2011) for type 2 diabetes.
  • WADA Not prohibited. GLP-1 receptor agonists are not on the WADA Prohibited List and are not banned substances; the class is tracked under WADA's monitoring program rather than prohibited.
Mazdutide

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

Approved
  • China (NMPA) Approved. China's National Medical Products Administration approved mazdutide in 2025, first for chronic weight management in adults with overweight or obesity and subsequently for glycemic control in adults with type 2 diabetes (Innovent Biologics).
  • United States (FDA) Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly).
  • Australia (TGA) Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
  • European Union (EMA) Not authorized; investigational, no marketing authorization.
  • WADA Not listed on the WADA Prohibited List. As an incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.
Orforglipron

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

Approved
  • United States (FDA) Approved. The FDA approved orforglipron (Foundayo) on April 1, 2026 for chronic weight management in adults with obesity, or overweight with weight-related conditions, based on the ATTAIN Phase 3 program. A type 2 diabetes indication (ACHIEVE program) is not yet approved.
  • Australia (TGA) Not entered on the Australian Register of Therapeutic Goods (ARTG); not yet approved for supply.
  • European Union (EMA) Not authorized; no marketing authorization at this time.
  • WADA Not listed on the WADA Prohibited List. As a GLP-1 receptor agonist it is not a banned substance.
Tesamorelin

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

Approved
  • United States (FDA) Approved. Egrifta (tesamorelin) approved in November 2010 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy; reformulated products (Egrifta SV, Egrifta WR) were subsequently approved for the same indication.
  • Australia (TGA) Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved tesamorelin product in Australia.
  • European Union (EMA) No EMA marketing authorisation; tesamorelin is not an approved medicine in the European Union.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth-hormone-releasing factors, including GHRH and its analogues such as tesamorelin, are prohibited. Athletes require a therapeutic use exemption.
Afamelanotide

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

Approved
  • United States (FDA) Approved October 2019 as Scenesse (afamelanotide) implant to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP); a prescription medicine administered by a physician.
  • Australia (TGA) 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.
  • European Union (EMA) Authorised in 2014 as Scenesse for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria.
  • WADA Not specifically named on the WADA Prohibited List; as an approved medicine used for a rare photodermatosis it does not fall within a listed prohibited class.
Gonadorelin

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

Approved
  • United States (FDA) Has a history of FDA approval: gonadorelin hydrochloride (Factrel) for evaluating pituitary gonadotropic function and gonadorelin acetate (Lutrepulse) for pulsatile induction of ovulation in hypothalamic amenorrhea. Several branded products have since been discontinued in the US (not for safety reasons), and gonadorelin is now commonly supplied via pharmacy compounding.
  • Australia (TGA) 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.
  • European Union (EMA) 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.
  • WADA Prohibited in males under Section S2: WADA lists gonadotropin-releasing hormone (GnRH) agonists among luteinising-hormone releasing factors, and gonadorelin is explicitly named; it is not prohibited in females.
Thymosin Alpha-1

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

Approved
  • United States (FDA) Not FDA-approved for any indication; remains investigational in the United States despite approval in many other countries, and has been the subject of US clinical study and orphan-drug interest without a marketing approval.
  • China (NMPA) and other markets Approved and marketed as thymalfasin (Zadaxin) in China and numerous other countries (reportedly more than 30) for chronic hepatitis B and C and as an immune-system adjuvant, with additional local uses such as adjunctive care in sepsis and some cancers. Prescription medicine where approved.
  • Australia (TGA) Not entered on the Australian Register of Therapeutic Goods (ARTG); no approved thymalfasin product in Australia.
  • European Union (EMA) No EMA centralized marketing authorisation; not authorised as a medicine at the EU level.
  • WADA Not listed by name on the WADA Prohibited List; as an immunomodulatory peptide it is not currently a named prohibited substance, though athletes should verify current status with their anti-doping organisation.
Elamipretide

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

Approved
  • United States (FDA) Granted accelerated approval on September 19, 2025 as Forzinity (elamipretide HCl) to improve muscle strength in adult and paediatric patients with Barth syndrome who weigh at least 30 kg, based on an intermediate endpoint (knee-extensor muscle strength) with a confirmatory trial required. It is not approved for any other indication, and the pivotal primary mitochondrial myopathy trial (MMPOWER-3) did not meet its primary endpoint.
  • Australia (TGA) Not on the ARTG; investigational only and not approved for supply.
  • European Union (EMA) No EMA marketing authorisation; not authorised as a medicine in the EU.
  • WADA Not listed by name on the Prohibited List; athletes should verify current status with their anti-doping organisation.
Retatrutide

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

Investigational
  • United States (FDA) Investigational; not approved. Phase 3 TRIUMPH program ongoing, with a first positive topline readout (TRIUMPH-4) reported in December 2025.
  • Australia (TGA) Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
  • European Union (EMA) Not authorized; investigational, no marketing authorization.
  • WADA Not listed on the WADA Prohibited List. As an investigational incretin-class agent it is not a banned substance; the closely related approved GLP-1 agonists are on WADA's monitoring program rather than prohibited.
Cagrilintide

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

Investigational
  • United States (FDA) Investigational; not approved as a standalone product. As part of the CagriSema combination (with semaglutide), a new drug application has been filed and an FDA decision is expected later in 2026.
  • Australia (TGA) Not entered on the ARTG; investigational only and not approved for supply.
  • European Union (EMA) Not authorized; investigational, no marketing authorization.
  • WADA Not listed on the WADA Prohibited List. Amylin analogues are not banned substances; as an investigational agent it falls outside approved therapeutic use.
KPV

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

Investigational
  • United States (FDA) Not FDA-approved; was on the 503A Category 2 list, removed April 2026, and scheduled for Pharmacy Compounding Advisory Committee review (July 2026).
  • Australia (TGA) No registered/approved product; an unapproved therapeutic substance.
  • European Union (EMA) No EMA marketing authorisation.
  • WADA Not specifically named on the Prohibited List.
Epithalon

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

Investigational
  • United States (FDA) Not FDA-approved for any indication. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (substances with significant safety concerns) restricting pharmacy compounding; subject of ongoing FDA compounding review in 2026.
  • Australia (TGA) Not approved by the TGA and not entered on the Australian Register of Therapeutic Goods (ARTG); no registered therapeutic product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not listed by name on the Prohibited List, but unapproved peptides of this type are generally captured by the S0 'Non-Approved Substances' category (any pharmacological substance with no current approval by a governmental health authority for human therapeutic use), which is prohibited at all times. Athletes should treat it as prohibited.
Selank

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

Investigational
  • United States (FDA) Not FDA-approved. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (significant safety concerns) restricting compounding; part of ongoing 2026 FDA compounding review.
  • Australia (TGA) Not approved by the TGA and not on the ARTG; no registered therapeutic product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not listed by name; because it lacks approval by major (stringent) regulatory authorities, it is generally treated as captured by the S0 'Non-Approved Substances' category, prohibited at all times. Athletes should treat it as prohibited.
Semax

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

Investigational
  • United States (FDA) Not FDA-approved; unscheduled. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (significant safety concerns) restricting compounding; part of ongoing 2026 FDA compounding review.
  • Australia (TGA) Not approved by the TGA and not on the ARTG; no registered therapeutic product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not listed by name; because it lacks approval by major (stringent) regulatory authorities, it is generally treated as captured by the S0 'Non-Approved Substances' category, prohibited at all times. Athletes should treat it as prohibited.
Survodutide

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

Investigational
  • United States (FDA) Investigational; not approved. Being evaluated in a Phase 3 program (SYNCHRONIZE) for obesity, with additional trials in MASH.
  • Australia (TGA) Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
  • European Union (EMA) Not authorized; investigational, no marketing authorization.
  • WADA Not listed on the WADA Prohibited List. As an investigational incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.
Hexarelin

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

Investigational
  • United States (FDA) Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product.
  • Australia (TGA) Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth hormone secretagogues and growth hormone-releasing peptides (GHRPs) are explicitly covered.
GHRP-2

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

Investigational
  • United States (FDA) Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product.
  • Australia (TGA) Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • Japan (PMDA) Approved as a diagnostic agent (pralmorelin) used to evaluate growth hormone secretory capacity; not approved as a therapeutic treatment.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth hormone secretagogues including GHRP-2 are explicitly covered.
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
  • United States (FDA) Not approved for any indication; an unapproved growth hormone secretagogue with no marketed product.
  • Australia (TGA) Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth hormone secretagogues including GHRP-6 are explicitly covered.
Follistatin

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

Investigational
  • United States (FDA) Not approved for any indication; follistatin-based gene therapies have been studied only in early-phase clinical trials.
  • Australia (TGA) Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S4.3 (Agents preventing activin receptor IIB activation), which explicitly names follistatin among myostatin-binding proteins; gene-therapy delivery may additionally be captured under M3 (Gene and Cell Doping).
Kisspeptin

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

Investigational
  • United States (FDA) Not approved for any indication; investigational and studied only in clinical research.
  • Australia (TGA) Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Prohibited in males under Section S2: WADA added kisspeptin to the 2024 Prohibited List as an example of a testosterone-stimulating peptide (a luteinising-hormone releasing factor); it is prohibited in males only, not in females.
Humanin

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

Investigational
  • United States (FDA) Not FDA-approved; a research/experimental peptide with no approved therapeutic use.
  • Australia (TGA) Not on the ARTG; an unapproved experimental substance.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not listed by name on the Prohibited List; as a non-approved substance, athletes should verify current status with their anti-doping organisation.
DSIP

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

Investigational
  • United States (FDA) Not FDA-approved; an experimental peptide with no approved therapeutic use.
  • Australia (TGA) Not on the ARTG; an unapproved experimental substance.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not listed by name on the Prohibited List; as a non-approved substance, athletes should verify current status with their anti-doping organisation.
LL-37

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

Investigational
  • United States (FDA) Not FDA-approved; an endogenous human peptide studied in early-stage research and not an approved drug.
  • Australia (TGA) Not on the ARTG; no approved LL-37 product.
  • European Union (EMA) No EMA marketing authorisation; investigated only in early clinical studies (for example, wound healing).
  • WADA Not listed by name on the Prohibited List; as an endogenous host-defence peptide it is not a named prohibited substance, but synthetic administration is unapproved and athletes should verify current status.
Dihexa

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

Investigational
  • United States (FDA) Not FDA-approved; an experimental nootropic peptide with no approved therapeutic use.
  • Australia (TGA) Not on the ARTG; an unapproved experimental substance.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not named on the Prohibited List, but as a non-approved substance it is captured by S0 (Non-Approved Substances), prohibited at all times; athletes should treat it as prohibited.
FOXO4-DRI

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

Investigational
  • United States (FDA) Not FDA-approved; an experimental senolytic peptide with no approved therapeutic use, and preclinical only.
  • Australia (TGA) Not on the ARTG; an unapproved experimental substance.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not named on the Prohibited List, but as a non-approved substance it falls under S0 (Non-Approved Substances), prohibited at all times; athletes should treat it as prohibited.
BPC-157

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

Restricted / Rx-only
  • United States (FDA) Not FDA-approved; barred from pharmacy compounding as a 503A Category 2 bulk drug substance (2023); no approved human indication.
  • Australia (TGA) Schedule 4 (Prescription Only Medicine) under the Poisons Standard (rescheduled 2025); no registered product, prescription/compounded supply only.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine.
  • WADA Prohibited at all times under S0 (non-approved substances) since 2022; no therapeutic use exemption available.
Melanotan II

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

Restricted / Rx-only
  • United States (FDA) Not approved for any use; the FDA treats melanotan II as an unapproved new drug that is marketed illegally, including as an injectable tanning product.
  • Australia (TGA) 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.
  • European Union (EMA) 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.
  • WADA Not specifically named on the WADA Prohibited List; melanocortin receptor agonists are not a listed prohibited class. As an unapproved substance, athletes should nonetheless verify its current status.
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

Prohibited
  • United States (FDA) Not FDA-approved; TB-500 placed on the 503A Category 2 list (barred from compounding). Full-length thymosin beta-4 (RGN-259) is a separate investigational drug in Phase 3 ophthalmic trials.
  • Australia (TGA) No registered/approved product; an unapproved therapeutic substance.
  • European Union (EMA) No EMA marketing authorisation.
  • WADA Prohibited at all times under S2 (peptide hormones, growth factors and mimetics) since 2011.
CJC-1295

Growth hormone-releasing hormone (GHRH) analog

Prohibited
  • United States (FDA) Not approved for any indication and never marketed. FDA placed CJC-1295 in Category 2 (potential significant safety risk) of the interim 503A bulk drug substances list; the nomination was later withdrawn/removed and the Pharmacy Compounding Advisory Committee did not recommend it for the 503A bulks list.
  • Australia (TGA) 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.
  • European Union (EMA) No EMA marketing authorization; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); GHRH analogues including CJC-1295 are explicitly listed.
Ipamorelin

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

Prohibited
  • United States (FDA) Not approved for any indication. FDA removed ipamorelin acetate from Category 2 of the interim 503A bulks list (September 2024) after the nomination was withdrawn and did not add it to the compoundable 503A list; PCAC review did not support inclusion.
  • Australia (TGA) Not on the ARTG; an unapproved growth hormone secretagogue. Supply for human therapeutic use is restricted (prescription-only class) with no approved indication.
  • European Union (EMA) No EMA marketing authorization; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S2; growth hormone secretagogues including ipamorelin are explicitly listed.
MOTS-c

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

Prohibited
  • United States (FDA) Not approved for any indication; an experimental peptide with no FDA-approved therapeutic use, and not an approved/compoundable drug substance.
  • Australia (TGA) Not on the ARTG; an unapproved experimental substance with no approved indication.
  • European Union (EMA) No EMA marketing authorization; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S4.4 (Metabolic Modulators), 4.4.1 Activators of AMP-activated protein kinase (AMPK); MOTS-c is explicitly named. No therapeutic use exemption is available because there is no approved therapeutic use.
AOD-9604

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

Prohibited
  • United States (FDA) Not approved as a drug; no New Drug Application and no approval for any indication. It holds self-affirmed GRAS (Generally Recognized As Safe) status as a food/dietary-supplement ingredient (a safety designation only, not an efficacy or drug approval). In 2024-2026 FDA compounding actions it was treated as a Category 2 substance, i.e. not eligible for 503A pharmacy compounding.
  • Australia (TGA) 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.
  • European Union (EMA) No EMA marketing authorization; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S2; explicitly listed as a growth hormone fragment (alongside hGH 176-191).
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

Prohibited
  • United States (FDA) Not approved for any human use; marketed as a research-use-only reagent, not for human administration. It is a distinct molecule from the approved recombinant human IGF-1 drug mecasermin (Increlex).
  • Australia (TGA) Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved substance with no registered therapeutic product.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); insulin-like growth factor-1 (IGF-1) and its analogues are explicitly covered.
GHK-Cu

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

Unclear
  • United States (FDA) Not an approved drug; topical form regulated as a cosmetic ingredient (Copper Tripeptide-1); injectable GHK-Cu was on the 503A Category 2 list (2023) and removed in April 2026 after nominations were withdrawn.
  • Australia (TGA) Permitted topically as a cosmetic ingredient; no approved medicinal (e.g., injectable) product.
  • European Union (EMA) Permitted cosmetic ingredient (INCI: Copper Tripeptide-1); no medicinal marketing authorisation.
  • WADA Not specifically named on the Prohibited List.
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
  • United States (FDA) Previously approved as Geref (sermorelin acetate) for the diagnosis and treatment of growth hormone deficiency; the product was discontinued and withdrawn from the US market around 2008 for commercial reasons, not because of safety or efficacy concerns. No FDA-approved sermorelin product is currently marketed; it is available in the US only through pharmacy compounding.
  • Australia (TGA) 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.
  • European Union (EMA) No current EMA marketing authorisation; not an approved medicine in the European Union.
  • WADA Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth-hormone-releasing factors, including GHRH and its analogues such as sermorelin, are prohibited.
Thymalin

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

Unclear
  • United States (FDA) Not FDA-approved; no US marketing approval and not an approved medicine.
  • Russia and former-Soviet states Registered and used clinically in Russia (and some neighbouring states) as an immunomodulatory thymic preparation; not evaluated or approved by the FDA, EMA or TGA.
  • Australia (TGA) Not on the ARTG; an unapproved substance in Australia.
  • European Union (EMA) No EMA marketing authorisation; not an approved medicine in the EU.
  • WADA Not listed by name on the Prohibited List; its status as a peptide immunomodulator is not clearly defined for anti-doping purposes, and athletes should verify current status with their anti-doping organisation.
Argireline

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

Unclear
  • United States (FDA) Not an FDA-approved drug. Marketed as a topical cosmetic ingredient (INCI: Acetyl Hexapeptide-8); cosmetic ingredients are not subject to FDA pre-market approval, and no therapeutic (drug) claims are authorised.
  • Australia (TGA) Permitted in topical cosmetics as a cosmetic ingredient; not an approved therapeutic (medicinal) product.
  • European Union (EMA) Permitted as a cosmetic ingredient (INCI: Acetyl Hexapeptide-8) under EU cosmetics regulation; no medicinal marketing authorisation.
  • WADA Not listed on the Prohibited List; a topical cosmetic peptide with no relevance to sport doping.

Regulatory classifications change; entries reflect the status recorded in each compound profile and are provided for reference, not as legal or medical advice.