CJC-1295 and ipamorelin: what the FDA has decided

CJC-1295 is a lab-made version of growth hormone-releasing hormone that is not FDA-approved, and as of Oct 27, 2026 a licensed pharmacy may not compound it, alone or blended with ipamorelin. In 2024 the FDA proposed keeping both peptides off the list of substances pharmacies may compound, and its advisory committee agreed: 13 to 0 against CJC-1295 and 12 to 0 against ipamorelin. This guide sets out what each peptide is, what the FDA decided and when, and how both differ from sermorelin and tesamorelin, two related peptides that can be prescribed. It covers legal status only, not dosing.

What CJC-1295 and ipamorelin are

Both are sold to raise the body’s own growth hormone, but they work on different receptors, which is why clinics and online sellers pair them.

CJC-1295 is, in the FDA’s words, a synthetic 29-amino-acid analog of growth hormone-releasing hormone (GHRH). ConjuChem, a Montreal company, developed a version with a “drug affinity complex” (DAC) that binds to albumin in the blood, so a single injection lasts for days rather than minutes. In its first human study, the estimated half-life was 5.8 to 8.1 days (Teichman 2006). Products sold as “CJC-1295” may or may not include DAC, and the FDA’s 2024 review warned that this inconsistent naming is itself a risk, because a patient may get a different substance than the one prescribed (FDA briefing).

Ipamorelin is a five-amino-acid peptide first described by Novo Nordisk researchers in 1998 (Raun 1998). It acts on the ghrelin receptor, also called the growth hormone secretagogue receptor, rather than the GHRH receptor.

Both FDA reviews note the pairing, quoting an expert who called it a “trending” combination, but neither review cites a clinical trial of the two used together.

Where each peptide stands

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How a peptide becomes legal to compound

Under section 503A of the Food, Drug, and Cosmetic Act, a pharmacy may compound from a bulk ingredient only if it has a USP or National Formulary monograph, is a component of an FDA-approved drug, or is on the FDA’s 503A bulks list (Federal Register). While that list is being built, the FDA says it won’t act against compounding with a substance in its Category 1, if it was nominated before Jan 7, 2025 and meets sourcing conditions (FDA interim policy).

CJC-1295 and ipamorelin pass none of these tests. Neither has a monograph, neither is part of an approved drug, neither is on the bulks list, and the FDA’s categories list, updated May 14, 2026, places neither in Category 1 (FDA).

December 2024: the CJC-1295 vote

The FDA reviewed five CJC-1295 substances (the free base, its acetate salt and three DAC forms) for growth hormone deficiency, the use the nominators proposed. The nominations had been withdrawn, and the FDA evaluated them on its own initiative. Its review concluded that the criteria “weigh against” adding any of them, citing unclear chemical characterization, little information on past use in compounding, possible safety concerns and no effectiveness data for growth hormone deficiency (FDA briefing).

On Dec 4, 2024, the Pharmacy Compounding Advisory Committee voted 13 to 0 against CJC-1295 (free base), 12 to 1 against CJC-1295 acetate, and 13 to 0 against each DAC form. One member “commented on the lack of evidence for effectiveness” (FDA minutes).

October 2024: the ipamorelin vote

The FDA reviewed ipamorelin for growth hormone deficiency and postoperative ileus, a stall in gut movement after surgery. It found no data supporting effectiveness for either use and proposed not adding it (FDA briefing). On Oct 29, 2024, the committee voted 0 to 12, with 1 abstention, on each form of ipamorelin. Members who voted no cited “a lack of information supporting safety and efficacy” (FDA minutes).

Ipamorelin acetate has also been in Category 2, the FDA’s list of substances that may present significant safety risks, for outsourcing facilities (503B) since Sep 29, 2023 (FDA).

What the FDA hasn’t done

An advisory vote is advice. The FDA has not published a final rule on either peptide, and none is needed to keep them out of pharmacies: without an approval, a monograph, a bulks-list entry or Category 1 status, a 503A pharmacy has no lawful basis to compound them. The FDA’s safety page now lists both under “nominated but withdrawn”, with its notes, and ipamorelin acetate also stays in its Category 2 table. For CJC-1295 it says the agency “has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited.” For ipamorelin it says a published study “identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility,” and that the agency “lacks sufficient information to know whether the drug would cause harm” by certain other injectable routes.

What the human studies measured

The published human research is small, and none of it tested muscle, body composition, aging or recovery.

• CJC-1295. Two randomized, placebo-controlled trials in healthy adults aged 21 to 61, lasting 28 and 49 days, gave single or repeated injections and measured growth hormone, IGF-1 and how long the drug stayed in the blood (Teichman 2006). A 2006 follow-up in healthy men aged 20 to 40 measured overnight growth hormone pulses a week after one injection.
• The stopped trial. ConjuChem’s phase 2 trial in people with HIV and excess belly fat, which started in December 2005, is listed as terminated (ClinicalTrials.gov). The FDA’s review cites reports that it stopped in 2006 after a participant died of a heart attack, which the attending physician attributed to underlying coronary artery disease. Its results were never published.
• Ipamorelin. In a phase 2 trial, 114 adults in hospital after bowel surgery received intravenous ipamorelin (0.03 mg/kg) or placebo twice a day for up to 7 days. The trial measured time to tolerating a solid meal and found no significant difference from placebo (Beck 2014). The FDA’s review says development for this use was reportedly discontinued.

A higher growth hormone or IGF-1 reading in a short study is a lab measurement, not evidence of a health benefit, and no trial has tested either peptide for the uses it is marketed for.

Sermorelin vs ipamorelin

Sermorelin is the closer relative of CJC-1295 than of ipamorelin: it is a copy of the first 29 amino acids of GHRH and acts on the GHRH receptor. The FDA approved it as Geref, made by EMD Serono, on Dec 28, 1990 as a test of pituitary function and on Sep 26, 1997 for idiopathic growth hormone deficiency in children with growth failure. EMD Serono discontinued it in 2008, and on Mar 4, 2013 the FDA determined it was not withdrawn for reasons of safety or effectiveness (Federal Register). That keeps sermorelin a component of an approved drug, so a 503A pharmacy may compound it.

That is the legal difference. Compounded sermorelin is still not FDA-approved, and prescribing it to adults for energy, sleep or body composition is off-label. Ipamorelin was never approved for any use and may not be compounded at all. Our guide on whether sermorelin is legal covers how it is prescribed.

Tesamorelin vs ipamorelin

Tesamorelin is a GHRH analog the FDA approved as Egrifta on Nov 10, 2010. Egrifta SV is indicated “for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy”. Its label says it is not indicated for weight loss management and that its long-term cardiovascular safety has not been established (DailyMed).

Its application was deemed a biologics license on Mar 23, 2020 (Drugs@FDA), and 503A compounding covers drugs, not biologics. So tesamorelin is approved, but only the brand can be prescribed, and a compounded tesamorelin offer isn’t lawful. Ipamorelin has neither an approval nor a compounding route. We compare tesamorelin and sermorelin in detail in tesamorelin vs sermorelin.

Sport and controlled-substance status

WADA’s 2026 Prohibited List bans all four at all times, in and out of competition. Class S2.2.4 names CJC-1295, sermorelin and tesamorelin as GHRH analogues and ipamorelin as a growth hormone secretagogue (WADA).

None of them appears on the DEA’s list of controlled substances, dated Oct 21, 2026 (DEA). Not being controlled doesn’t make a peptide legal to sell as a drug: without an approval or a lawful compounding route, there is no legitimate source.

What about vials labeled for research?

CJC-1295 and ipamorelin are widely sold online in vials labeled for laboratory research. Buying these to inject is unsafe and unregulated: no prescriber decides whether it suits you, no licensed pharmacy answers for what is in the vial, and no one has checked its identity, strength or sterility. The FDA’s own review found that sellers use the CJC-1295 name for different molecules. If a website offers you a prescription for compounded CJC-1295 or ipamorelin today, it is offering something a licensed pharmacy may not lawfully make. Our guide on whether peptides are safe covers how to check a provider.

The bottom line

CJC-1295 and ipamorelin have no FDA approval and no lawful compounding route as of Oct 27, 2026. The FDA reviewed both in 2024, proposed keeping both off the compounding list, and its advisers agreed by wide margins. If you are interested in growth hormone-related treatment, the options a clinician can lawfully prescribe are compounded sermorelin, used off-label in adults, and brand-name tesamorelin for its one approved use. For every other peptide, see are peptides legal in 2026 or the peptides hub.