Is ipamorelin legal in Australia? Poisons Standard, TGA, FDA and WADA records

Evidence limits

What do these legal records not decide?

Three kinds of authority appear on this page, and they do different jobs. The Poisons Standard and the TGA decide how a substance is controlled in Australia. The FDA decides what may be sold or compounded in the United States. WADA decides what athletes may not use. A decision by one does not change the record of the other two.

Is ipamorelin legal in Australia?

The October 2026 Poisons Standard (instrument F2026L01327) lists '# IPAMORELIN.' in Schedule 4, the prescription-only schedule, and names IPAMORELIN as item 25 in Appendix D, clause 5. That table covers 'poisons that must not be possessed by a person without authority (for example, possession other than in accordance with a legal prescription)'. Section 64(4) applies the rule: a poison in the clause 5 table must not be possessed without authority under the law of the jurisdiction where possession occurs. The Standard says a # marks a substance also listed in Appendix D (read 14 October 2026 on legislation.gov.au).

Schedule 4 is the prescription-only tier. Appendix D is a second list, for poisons where a further condition applies. What Schedule 4 and Appendix D mean walks through both lists, and the Australian law hub sets ipamorelin beside the other catalogue peptides.

Other substances in the same family appear in the same clause 5 table: GHRP-6 at item 20, hexarelin at item 22 and ibutamoren at item 23. Sermorelin has an individual Schedule 4 entry; this page does not determine how the Appendix D group entries apply to it, which the Australian law hub covers (October 2026 Poisons Standard, read 14 October 2026).

What did the TGA decide about ipamorelin, and why?

A delegate of the Secretary to the Department of Health decided to add ipamorelin to Schedule 4 and Appendix D, in a final-decision notice dated 19 March 2015 that followed an advisory committee meeting on 18 November 2014. The implementation date was 1 June 2015. The delegate gave reasons that included limited information on risks and benefits, advertising of these substances as performance and image enhancing drugs, potential for side effects like those of growth hormone, misuse in sport and by body builders, and sale over the internet with unproven claims; those are reasons for a class of substances, not findings about ipamorelin alone (TGA, Delegates' final decisions, March 2015).

The notice grouped ipamorelin with CJC-1295, GHRP-2, GHRP-6, hexarelin and AOD-9604, and with the classes of growth hormone-releasing hormones, releasing peptides and secretagogues. It also records that the long-term safety of these substances was not established, and it notes an infection risk where needles are used without infection-control procedures (TGA, March 2015).

The 2015 notice and the FDA's 2024 review are separate records from different authorities; the ipamorelin study-findings page covers the studies and the FDA review.

Why is ipamorelin banned?

Ipamorelin is restricted by three authorities, and each gives its own reason. Australia's delegate cited limited risk and benefit information, misuse in sport and by body builders, and unproven online claims (TGA, March 2015). The FDA found it is not in any approved drug, that its evidence of effectiveness for growth hormone deficiency or postoperative ileus is limited, and that the balance of characterisation, safety and effectiveness information weighs against adding it to the 503A compounding list (FDA review memo, 19 August 2024). WADA prohibits it at all times because it is a growth hormone secretagogue named in S2.2.4 (WADA 2026 List). 'Banned' is therefore three different records.

The word 'banned' also hides a difference between sport and law. A WADA listing applies to athletes under anti-doping rules. A Schedule 4 listing controls supply and prescribing, and Appendix D adds the possession rule. The FDA's position concerns compounding in the United States. None of them is a general criminal ban on the molecule, and none of them says the same thing.

Does a research-use label change ipamorelin's legal status in Australia?

No. The TGA's advisory of 13 April 2026 states that 'research use only' disclaimers do not make the supply of a product lawful, and that these disclaimers alone do not change a product's regulatory status, permit importation or remove advertising or supply obligations. The advisory adds that unapproved peptide products have not been assessed by the TGA for safety, quality or effectiveness, and that state and territory laws may impose additional controls. The Poisons Standard entry applies to the substance whatever its label says (TGA safety advisory, 13 April 2026; Poisons Standard, October 2026, read 14 October 2026).

The advisory names BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295 as examples of unapproved peptide products, and it does not name ipamorelin in the text read for this page, so it is a record about a group. It sets out the adverse events the TGA has received for the group, covered on the ipamorelin side effects page.

Is ipamorelin FDA approved?

No. The FDA's review memo of 19 August 2024, published in the 29 October 2024 advisory committee briefing document, states that there is no US Pharmacopeia monograph for ipamorelin or its acetate form and that neither is a component of an FDA-approved drug. The FDA evaluated two uses, growth hormone deficiency and postoperative ileus. It concluded that evidence of effectiveness is limited for any route and that professional society guidelines do not discuss ipamorelin for either use (FDA PCAC briefing document, 29 October 2024).

The FDA also noted that approved treatments already exist for both conditions, including an approved product for postoperative ileus. The one published trial of ipamorelin for that condition found in the sources read for this page, in 117 enrolled bowel-surgery patients (114 analysed), showed no statistically significant difference from placebo in time to first tolerated meal; it is a single small postoperative trial that cannot show that no difference exists (Beck et al., International Journal of Colorectal Disease, 2014).

Approval is separate from compounding. A substance can be absent from every approved drug and still come before a compounding committee, which is the question the committee took up next.

What did the FDA decide about compounded ipamorelin and sermorelin?

On 29 October 2024 the FDA's Pharmacy Compounding Advisory Committee voted 0 yes, 12 no and 1 abstention on placing ipamorelin acetate on the 503A bulks list, and the same result for ipamorelin free base (FDA final summary minutes, 29 October 2024). The votes are advice, not final decisions. Separately, the FDA's category 2 page lists ipamorelin acetate for the 503B pathway as a substance that may present significant safety risks, added on 29 September 2023 (FDA category 2 page, content current as of 22 April 2026). The final FDA determination was not found in the sources opened for this page.

Sermorelin has a different record. The FDA approved sermorelin acetate as GEREF in 1990 and 1997, the maker notified the FDA of discontinuation in 2008, the FDA withdrew approval effective 18 June 2009, and the FDA determined on 4 March 2013 that it was not withdrawn for reasons of safety or effectiveness (Federal Register, volume 78, number 42). No source opened for this page shows a category 2 listing for sermorelin. The two compounds therefore sit under different FDA records, and the tesamorelin, sermorelin and ipamorelin comparison sets them side by side.

Is ipamorelin prohibited in sport, and is GHRP-6?

Yes. The WADA 2026 Prohibited List, in force from 1 January 2026, names ipamorelin in S2.2.4 among growth hormone secretagogues and their mimetics, and names GHRP-6 among the GH-releasing peptides in the same clause. Class S2 is prohibited at all times, in and out of competition. Sport Integrity Australia lists ipamorelin among common unapproved peptides prohibited in sport and says that possession or use by an athlete can lead to an anti-doping rule violation and a ban (Sport Integrity Australia peptides page, read 14 October 2026).

WADA also names CJC-1295, sermorelin, tesamorelin, ibutamoren (MK-677) and hexarelin in S2.2.4. WADA issues a new list each year, so this page read the 2026 edition only.

Do peptides show up on drug tests? covers testing and the athletes' pathway in more detail.