Is CJC-1295 legal in Australia? TGA, FDA and WADA status

Is CJC-1295 legal in Australia?

CJC-1295 is named in Schedule 4 of the October 2026 Poisons Standard, the instrument F2026L01327, which covers prescription-only medicines. The entry reads '# CJC-1295 (CAS No. 863288-34-0).' and the same name is item 7 of Appendix D, clause 5, the table of poisons that the instrument says 'must not be possessed by a person without authority' (Poisons Standard F2026L01327, in force 1 October 2026; read 14 October 2026). A research-use-only label does not make supply lawful (TGA advisory, 13 April 2026). Whether a given act is lawful depends on the person, the product and the activity, and this page gives no legal advice.

The instrument's note to Schedule 4 says that substances marked # are listed in Appendix D. The Western Australian law page explains the state layer, which can add controls on possession and supply.

The Poisons Standard text is on the Federal Register of Legislation. The CAS number is a registry number that identifies one chemical. The instrument names CJC-1295 with that one number and does not use the words with DAC or without DAC.

Evidence limits

What does this page not decide about CJC-1295?

Section 7 of the instrument says that, unless the contrary intention appears, a reference to a substance includes every salt, active principle or derivative of it, and a preparation or admixture containing any proportion of it (F2026L01327). A named entry can therefore reach more than the exact name. This page does not apply that rule to any product, and it reports no Australian Register of Therapeutic Goods database lookup for CJC-1295; neither a missing named entry nor a register entry for another product decides the status of a given product.

What has the TGA said about CJC-1295?

The Therapeutic Goods Administration (TGA) named CJC-1295 in its safety advisory of 13 April 2026, as one example of an unapproved peptide product, alongside BPC-157, GHK-Cu, TB-500 and retatrutide. The TGA says such products 'have not been evaluated for safety, quality or effectiveness by the TGA'. It also states that a 'research use only' disclaimer 'does not make its supply lawful' and does not change a product's regulatory status, permit importation, or remove advertising or supply obligations. State and territory laws may add controls on sale, supply and possession.

The advisory defines unapproved peptide products as goods not included in the Australian Register of Therapeutic Goods (ARTG), the national list of approved goods (TGA, 13 April 2026). The advisory itself does not name ipamorelin in its example list, and an example list is not a full classification table.

The TGA's import rules, including the Personal Importation Scheme, sit on the Australian peptide law page with their own dates.

Is CJC-1295 FDA approved?

No. CJC-1295 has no record in Drugs@FDA, the FDA's database of approved drug applications; an openFDA search of the Drugs@FDA applications field products.active_ingredients.name for "cjc-1295" on 14 October 2026 returned no match (CJC-1295 query). The same field searched for ipamorelin (ipamorelin query) and hexarelin (hexarelin query) returned no match. Tesamorelin, a different growth hormone-releasing hormone analogue, returned one application, BLA022505 for the medicine Egrifta, with an original submission status date of 10 November 2010 (tesamorelin query; Purple Book record). The FDA's compounding lists treat CJC-1295 as a substance with open safety questions (FDA page, content current as of 22 April 2026).

Approval is a record for one product, not for a molecule name. Tesamorelin's approval was supported by randomised trials in adults with HIV and abdominal fat, including a 412-person trial of 26 weeks (Falutz et al., New England Journal of Medicine, 2007), while CJC-1295 has two short trials in healthy adults with no participant count in the abstract, so the two records describe different people (Teichman et al., Journal of Clinical Endocrinology & Metabolism, 2006). The comparison page sets the two side by side. The openFDA search covers Drugs@FDA applications only, so it cannot show other FDA records.

What is the FDA's warning about CJC-1295 in compounded drugs?

The FDA says compounded drugs containing CJC-1295 may pose an immunogenicity risk for certain routes, and may have complexities with peptide-related impurities and with characterising the active ingredient. Immunogenicity means the body may react to the peptide as a foreign substance. The FDA adds that it 'has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction' and that 'available clinical data are limited', without naming the report behind the events (FDA page on bulk drug substances that may present significant safety risks, content current as of 22 April 2026, read 14 October 2026).

On that page, CJC-1295 sits under the heading for bulk drug substances 'nominated but withdrawn', a list the FDA describes as substances 'previously in category 2 of the interim policies' that 'were withdrawn by the nominators'. The page keeps the safety text beside the name. This is a compounding-policy page, not a warning letter, and no FDA warning letter naming CJC-1295 was reviewed for this page. The FDA page holds the full wording.

What did the FDA advisory committee decide about CJC-1295?

On 4 December 2024, the FDA's Pharmacy Compounding Advisory Committee voted 0 yes and 13 no on placing CJC-1295 (free base) on the 503A bulks list, the list of bulk substances that pharmacies may compound from, and the vote is advice to the FDA and not a final rule (FDA final summary minutes, 4 December 2024). The same minutes record 1 yes and 12 no for CJC-1295 acetate and 0 yes and 13 no for each of three with-DAC forms, and one member commenting on the lack of evidence for effectiveness, again as advisory votes only (FDA final summary minutes, 4 December 2024).

The same committee met on 29 October 2024 on ipamorelin. Its votes on ipamorelin (free base) and ipamorelin acetate were each 0 yes, 12 no and 1 abstain, and the minutes record members citing a lack of information supporting safety and efficacy for the conditions presented, as advisory votes and not a final rule (FDA, final summary minutes, 29 October 2024). The December 2024 minutes and October 2024 minutes are on the FDA site.

What has the FDA said about ipamorelin?

The FDA lists ipamorelin acetate in category 2 of its interim compounding policy for outsourcing facilities (503B), added on 29 September 2023. It says compounded drugs containing it may pose an immunogenicity risk, and that a study published in the literature identified serious adverse events including death in ipamorelin used for gastric motility; the page's linked reference for that study is Beck et al. (2014), PubMed 25331030, and this page infers no death count or cause from that abstract (FDA page, content current as of 22 April 2026). The FDA says it has not identified safety information for certain other routes and so lacks sufficient information to know whether harm would result. No ipamorelin product has a Drugs@FDA record.

The FDA text covers risks of compounded products. It does not describe an approval, and it does not treat CJC-1295 and ipamorelin as a pair. In primary rat pituitary cells, the five-amino-acid peptide ipamorelin released growth hormone through a receptor of the growth hormone-releasing peptide type and not through the GHRH receptor, in a cell and animal study that does not describe human use (Raun et al., European Journal of Endocrinology, 1998).

Is CJC-1295 prohibited by WADA?

Yes. The World Anti-Doping Agency's 2026 Prohibited List, in effect from 1 January 2026, names CJC-1295 in S2.2.4 (growth hormone releasing factors) as an example of a growth hormone-releasing hormone analogue, beside CJC-1293, sermorelin and tesamorelin. Class S2 is 'prohibited at all times (in- and out-of-competition)', and every substance in it is a non-Specified Substance. The same section names ipamorelin among growth hormone secretagogues and examorelin (hexarelin) among growth hormone-releasing peptides (WADA, 2026 List). Sport Integrity Australia also names CJC-1295 and ipamorelin as common unapproved peptides prohibited in sport.

This page reads the 2026 List only, and a later List may differ.

Sport Integrity Australia's peptides page, read on 14 October 2026, says a Therapeutic Use Exemption is unlikely to be granted for an unregistered medicine, and that athletes may then face an anti-doping rule violation.

Does a research-use-only label change any of this?

No. The TGA states that a 'research use only' disclaimer does not change a product's regulatory status, permit importation, or remove advertising or supply obligations (TGA, 13 April 2026). The label describes the intended use of laboratory material; it is not a legal status. Research material is not a medicine, is not a substitute for one, and is not for human or animal use. The catalogue lists CJC-1295 (No DAC) and ipamorelin reference material as one blend in a single vial.