Which peptides are approved in Australia and by the FDA?

What peptides are approved in Australia?

The TGA says peptide-based medicines on the ARTG include insulin and insulin analogues, glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide, oxytocin, vasopressin analogues such as desmopressin, and somatostatin analogues such as octreotide (TGA, How we regulate therapeutic peptide products, checked 14 October 2026). Tirzepatide, the peptide in Mounjaro, entered the ARTG on 23 December 2022 for type 2 diabetes, and a weight-management extension followed on 10 September 2024 (TGA AusPAR for Mounjaro, finalised 20 September 2024). Each approval covers a named product and its stated purpose.

GLP-1 is one of the hormones your gut releases after a meal to tell your brain to ease off. Semaglutide and tirzepatide are lab-made peptides designed to act on that signal. Tirzepatide also acts on a second gut hormone, GIP (Coskun et al., Molecular Metabolism, 2018).

The TGA states that these medicines are tested broadly in human clinical trials before approval, and that many approved peptide-based medicines are prescription-only, so only authorised health practitioners can prescribe, dispense or supply them (TGA, checked 14 October 2026). Tirzepatide also has a Schedule 4 entry in the October 2026 Poisons Standard, instrument F2026L01327, read on 1 October 2026, as the Australian law hub records.

Are peptides available in Australia?

Approved peptide medicines are available in Australia through authorised health practitioners, because many are prescription-only (TGA, How we regulate therapeutic peptide products, checked 14 October 2026). Unapproved peptide products cannot be imported or supplied in Australia unless a valid exemption, approval or authority applies, and the TGA says a 'research use only' label does not change that. The TGA's overview of 23 September 2026 adds that many peptide products promoted online are unapproved therapeutic goods that 'may be unlawful to import, supply or advertise'.

Availability and approval are two different facts. A medicine can be approved and still need a prescription. A product can be easy to find online and still be unapproved. In a joint statement on 19 June 2026, the TGA and the Chief Medical Officer called unapproved peptide products a growing public health risk and said that some have not undergone sufficient human clinical trials, which is a health warning and not a legal ruling.

The research reference material offered on this site is not an approved medicine, is not a substitute for one, and is not for human or animal use. The Australian law hub sets out the Schedule 4, Appendix D, import and sport rules that apply to named peptides, each with a check date.

Which peptides are FDA approved now?

The FDA has approved many peptide medicines, and this page does not claim a complete list. Labels on DailyMed, checked 14 October 2026, state Initial U.S. Approval in 2022 for tirzepatide (Mounjaro label), 2017 for semaglutide (Ozempic label), 2010 for tesamorelin (Egrifta label), 1988 for octreotide (octreotide acetate label), 1982 for human insulin (Humulin R label) and 1978 for desmopressin (desmopressin acetate label). Each year is the one printed on the label itself. A 2021 review in Nature Reviews Drug Discovery counted more than 80 peptide drugs on the market worldwide, and a 2022 review counted 33 non-insulin peptide drugs approved worldwide since 2000, both counts from literature reviews and not from a regulator's register (Muttenthaler et al., 2021; Wang et al., Signal Transduction and Targeted Therapy, 2022).

FDA approval attaches to a product and its labelled use. It does not attach to a molecule's name. Compounding, where a pharmacy mixes a medicine for one patient, is a separate US pathway. The FDA's section 503A page, current as of 14 May 2026, says a compounder may use only bulk substances that meet a pharmacopoeia monograph, are components of FDA-approved drugs, or appear on the 503A bulks list.

A peptide under discussion is not a peptide approved. The FDA's agenda for its 23 and 24 July 2026 advisory committee meeting lists seven peptides for discussion for the 503A bulks list: BPC-157, KPV, TB-500, MOTs-C, emideltide, semax and epitalon (FDA meeting page, checked 14 October 2026). The FDA states that advisory committees make non-binding recommendations. The Australian law hub covers the FDA compounding lists in more detail, and how retatrutide differs from Mounjaro and Ozempic compares an unapproved molecule with approved medicines.

How does an approved peptide medicine differ from a research peptide?

An approved peptide medicine has been assessed by a regulator for quality, safety and effectiveness. A research peptide has not. The TGA says unapproved peptide products have not been assessed for safety, quality or effectiveness, so there is no assurance they are correctly labelled, sterile or made to appropriate quality standards (TGA, Peptide products, updated 23 September 2026). The two can share a molecule name and still differ in manufacturing, testing, labelling and the evidence reviewed. An approval is a statement about one product, one labelled use and one body of evidence.

The TGA's alert of 14 September 2026 shows why the difference matters. In one case, TGA laboratory testing of a single sample of a product sold as retatrutide, obtained after a serious adverse event report, found semaglutide that was not declared and no retatrutide, a finding that describes that sample and not other products (TGA safety alert, 14 September 2026; retatrutide's legal status in Australia has the full record).

The FDA reached the same point on labels in warning letters dated 24 August 2026 to online sellers. One of those letters says that statements such as 'research use only' did not change the fact that the seller's products were intended to be drugs for human use, and it lists products including retatrutide as unapproved new drugs (FDA warning letter 734884, 24 August 2026).

Two names show the split. The TGA lists BPC-157 and retatrutide among its examples of unapproved peptide products (TGA, 13 April 2026). The BPC-157 research guide and the retatrutide research guide describe the published studies on each compound. A study record is not an approval.

Evidence limits

What can this page not show?

Initial U.S. Approval is a line printed on a label. It shows the first year a product's active ingredient was approved, as the label reports it, and it says nothing about current supply. Scheduling under the Poisons Standard, TGA approval and state or territory law are three separate questions, each with its own record.