GPs are increasingly being approached by patients inquiring about the use of peptides other than incretin-based therapies. These non-incretin-based peptides are increasingly promoted on social media for injury repair, muscle gain and fat loss, sleep, cognition, sexual function and “longevity.”
But while the sales pitch is often confident, the evidence base is not.
This week the Medical Board of Australia issued a warning to health professionals, describing “a massive uptick in unapproved peptide use that raises safety concerns.” While some consumers are sourcing the products directly online, “Others are sourcing them from registered practitioners who are not meeting their professional responsibility to only prescribe peptides when there is a clinical need and evidence to support the treatment,” the Board said.[1]
A structured web search undertaken on 26 July 2026 identified at least 115 Australian-facing websites promoting these products: 89 direct suppliers or storefronts and 26 offering an online clinical, prescribing or medical-pharmacy pathway. Seventy-three used an Australian .au domain.
These figures can at best be regarded as an estimation. Websites open, close and rebrand rapidly; social-media-only sellers and non-indexed sites were not captured. Inclusion does not establish that a business is Australian-owned, lawful, clinically appropriate or supplying every product displayed. Conversely, “research use only” does not neutralise a website’s therapeutic claims or make possession and use lawful.
On 23-24 July 2026, the US Food and Drug Administration’s Pharmacy Compounding Advisory Committee recommended that six of seven peptides it assessed (BPC-157, KPV, TB-500,MOTS-c, epitalon and semax) be considered for inclusion on the section 503A Bulks List, potentially permitting their use in patient-specific compounded preparations.[2,7]
The votes were close and advisory. The FDA has not yet accepted the recommendations, and inclusion on a compounding list would not constitute FDA approval or establish efficacy, safety, quality, an accepted indication or a standard dose.
The committee vote represents a policy judgment about access to compounding, made despite an extreme paucity of scientific evidence. It should not be presented to patients as validation of peptide therapy or evidence that these products are suitable for prescribing.
More importantly, the FDA’s own scientific assessments recommended against listing all seven substances.[3–6]
Here is a closer look at four of the peptides the FDA reviewed which are particularly relevant for GPs.
BPC-157 is a synthetic 15-amino-acid peptide.
The FDA found BPC-157, inadequately characterised, historical compounding data limited, safety and immunogenicity insufficiently defined, and evidence inadequate to establish effectiveness.
The data regarding the isolation and synthesis of BPC 157 come from a single laboratory and have not been reproduced. Furthermore, the gene responsible for the synthesis of the peptide has never been identified. Most widely cited healing claims arise from animal or laboratory experiments. Initial trials done in humans for treating ulcerative colitis were negative. There is no reliable human data to support efficacy for tendon repair.[3]
KPV is a three-amino-acid C-terminal fragment of alpha-melanocyte-stimulating hormone.
Despite KPV being promoted for inflammation, wound healing and gastrointestinal or skin disorders, the FDA found no human administration data and insufficient clinical or nonclinical safety information. Potential aggregation, impurities and immunogenicity remain unresolved.[4]
TB-500 is an N-terminally acetylated seven-amino-acid synthetic fragment of thymosin beta-4 corresponding to residues 17–2.
The FDA found no clinical evidence supporting wound healing, no adequate toxicology, uncertain product identity and a potential immunogenicity risk with injection. Evidence concerning full-length thymosin beta-4 cannot simply be transferred to products sold as TB-500.[5]
MOTS-c is a mitochondrially encoded 16-amino-acid peptide.
Claims about insulin sensitivity, obesity, performance and longevity derive predominantly from cellular and animal research. The FDA found no clinical studies or publicly available human exposure data for administered MOTS-c, no adequate toxicology, uncertain characterisation and unresolved immunogenicity.[6]
The same caution applies to a large range of other non-GLP-1-related peptides that are promoted well beyond the supporting human evidence and in the absence of adequate safety data.[8]
Unapproved peptides are not included in the Australian Register of Therapeutic Goods and have not been evaluated by the TGA for safety, quality or effectiveness. Many are prescription-only substances listed in the poison’s standard. Most are also prohibited in sport.
Compounding is a mechanism for meeting a genuine individual clinical need. It is not a substitute for product approval, nor evidence that benefit outweighs harm. Advertising prescription-only or unapproved therapeutic goods to the public is generally prohibited.[9,10]
In June 2026, the TGA reported liver injury, severe allergic reactions requiring adrenaline and hospitalisation, inflammation and other complications associated with unapproved peptide products. Additional hazards include incorrect identity or strength, microbial or endotoxin contamination, peptide aggregates, injection-site injury and delayed diagnosis or effective treatment for underlying disorders.[9,10]
The Medical Board said it is working with AHPRA to investigate unsafe prescribing and compounding practices, noting that some practitioners have had their registration, restricted, suspended or cancelled.[1]
Ask patients directly if they are using these products. Patients may not regard these products as medicines. Ask their names and record the product, source, route, dose, duration, claimed indication and concurrent hormones, supplements or performance-enhancing drugs. Photograph packaging and retain batch details where possible.
Assess according to exposure and symptoms. Consider injection-site infection, allergy, hepatic injury, renal dysfunction, glucose disturbance and consequences of activation of the growth hormone pathway. Consider the presence of underlying disorders and point patients to appropriate evidence-based therapies. Report adverse events and suspect products to the TGA.
Athletes should be warned explicitly about anti-doping rules.
The practical message is that a biologically plausible mechanism does not make something clinically effective, and absence of reported harm is not evidence of safety. There are also currently no approved products available, and therefore no quality assurance.
While it’s understandable that people are curious about peptide therapeutics, routine clinical use ahead of adequate trials, reliable manufacturing and regulatory assessment is not.
The Medical Board is developing new guidance for off-label, unapproved and compounded medicines, including peptides.[1]
1. Medical Board of Australia. July 2026 newsletter. Prescribing in new medical frontiers. 24 July 2026.
2. US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026.
3. US Food and Drug Administration. Evaluation of BPC-157-related bulk drug substances. 2026.
4. US Food and Drug Administration. Evaluation of KPV-related bulk drug substances. 2026.
5. US Food and Drug Administration. Evaluation of TB-500-related bulk drug substances. 2026.
6. US Food and Drug Administration. Evaluation of MOTS-c-related bulk drug substances. 2026.
7. Reuters. FDA advisers back four unapproved peptides under review for less restrictive compounding rules. 23 July 2026.
8. US Food and Drug Administration. Bulk drug substances used in compounding that may present significant safety risks.
9. Therapeutic Goods Administration. Public-health risks associated with unapproved peptide products. 19 June 2026.
10. Therapeutic Goods Administration. Importing, compounding and supplying unapproved peptide products. 13 April 2026.
Disclosure: AI was used for the structured Web search to assess the Australian market. Limited use of AI has been used to assist with clarity of the text and to identify and correct typographical errors.
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