CJC-1295 is two different molecules. The human data belongs to one of them.

Why this note exists

Most compounds in this index are unapproved and under-studied, which is unremarkable. CJC-1295 is a narrower and more interesting problem: there is real human pharmacology behind the name, it is twenty years old, it is small, and it does not belong to the version most of the market sells.

In the index generated on August 15, 2026, 82 of 112 vendors carried a CJC-1295 listing — 177 listings in all. Only fourteen of the 83 compounds in the index are carried by more vendors.[19] Of those 177 listings, 103 name a form without DAC, using "no DAC", "without DAC", "w/o DAC" or "mod GRF 1-29"; 57 name a DAC form; 17 name neither.[19] At the vendor level, 38 sellers carry only the no-DAC form, 8 only the DAC form, 32 carry both, and 4 never state which.[19] Twenty of the listings are blends, most of them with ipamorelin.[19]

A note on what kind of evidence this is: every efficacy and safety figure below carries its design, species and participant count. Animal and in vitro toxicology is confined to one paragraph and labeled. Where FDA characterizes something as anecdotal, this note says so in the same sentence. pepmg does not claim to know what is in any vendor's vial; the listing counts above are counts of what sellers wrote on their own product pages.

The identity problem

Five substances, nine names, two molecules

The distinction is structural, not cosmetic. FDA's evaluation records that CJC-1295 free base is a synthetic 29-amino-acid analogue of growth hormone releasing hormone with substitutions at positions 2, 8, 15 and 27, molecular formula C₁₅₂H₂₅₂N₄₄O₄₂, molecular weight 3367.95, CAS 446036-97-1.[1] ConjuChem then added a maleimidopropionamide-lysine unit at the C terminus, producing the substance FDA calls CJC-1295 DAC free base — CAS 446262-90-4, molecular weight 3647.95 — which bioconjugates to endogenous albumin in vivo, and to which FDA attributes "the greater stability and longer half-life of CJC-1295 DAC compared to GHRH_1-29."[1] That work was published in rats in 2005, and it is where the name CJC-1295 was assigned.[9]

FDA is blunt about the consequence for anyone buying by name. Its evaluation states that "there appear to be inconsistent naming conventions associated with CJC-1295-related BDSs," that "[t]his represents a safety risk for patients as they may be dosed with a different BDS than the physician ordered," and that "[t]here are at least nine different names that have been used over time for these five BDSs."[1] Both nominations submitted to FDA were themselves internally inconsistent: one named "CJC-1295" but supplied a chemical name that "does not correspond to any of the known CJC-1295-related BDSs," the other named "CJC-1295 Acetate" but supplied a certificate of analysis for "Tetra-substituted GRF 1-29 (CJC-1295) Acetate" whose formula and molecular weight match CJC-1295 free base, alongside a CAS number FDA notes has been deleted — while the clinical references in both packages refer to CJC-1295 DAC.[1]

That last detail is the whole note in miniature. The paperwork nominating a substance for compounding cited human studies of a different molecule than the one it was nominating. The market has the same habit, and the market has 177 listings.

The human evidence

Three studies, 63 healthy volunteers, zero patients

The entire published human record for CJC-1295 is three papers, none of them in anyone with the condition the substance was nominated to treat. FDA's evaluation names them: Teichman et al. 2006, Ionescu and Frohman 2006, and Sackmann-Sala et al. 2009.[1]

Participant counts as reported in the papers and in FDA's evaluation of them; the Teichman figure is the sum of the group denominators FDA reports for the two trials (35 plus 7, and 24), which the paper does not state as a combined enrollment. FDA's own tally across all three studies: 63 healthy adults exposed, 55 of them (87%) men, 46 of them (73%) having received only one dose, at doses ranging from 30 to 250 mcg/kg.[1][6][7][8]

What those studies measured was the hormone axis, not an outcome. Teichman and colleagues set out "to examine the pharmacokinetic profile, pharmacodynamic effects, and safety" of the compound; the main outcome measures were peak concentrations and area under the curve of growth hormone and IGF-1.[6] The findings are consistent and, on their own terms, unambiguous: after a single injection, mean plasma growth hormone rose 2- to 10-fold for six days or more and IGF-1 by 1.5- to 3-fold for nine to eleven days, with an estimated half-life of 5.8 to 8.1 days; after multiple doses, mean IGF-1 stayed above baseline for up to 28 days.[6] Ionescu and Frohman found that the increase came mostly from the troughs — basal growth hormone up 7.5-fold, mean levels up 46%, IGF-1 up 45% — with the frequency and magnitude of secretory pulses unaltered.[7]

Those are pharmacodynamic results in people with intact pituitaries, and the authors of the first study said as much themselves, concluding that "[f]uture studies are indicated to evaluate the clinical utility of treatment with CJC-1295 in patients with intact GH secretory capacity."[1][6] Twenty years later those future studies have not been published.

FDA's summary of the effectiveness criterion is one sentence long and worth quoting whole: "There are no studies evaluating effectiveness in humans with GHD for any of the evaluated substances."[1] It adds that it "was not able to identify studies in which CJC-1295 (free base), CJC-1295 acetate, CJC-1295 DAC acetate, and CJC-1295 DAC TFA were studied in humans," that none of the substances appears in the growth hormone treatment guidelines of the Growth Hormone Research Society, the American Association of Clinical Endocrinologists, the Pediatric Endocrine Society or the Endocrine Society, and that because the three studies were run in healthy adults and did not measure body composition or height velocity, "they do not support effectiveness for the treatment of GHD."[1]

The trial that would have answered a real question, and how it ended

There was one. ClinicalTrials.gov carries a single registered interventional study of CJC-1295: NCT00267527, sponsored by ConjuChem, "A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks in HIV Infected Patients With HIV Associated Visceral Obesity."[11][12] Enrollment 120. Start December 2005. Status terminated. Last updated October 2006, with no results posted in the two decades since.[11]

FDA's evaluation carries an account of how a ConjuChem Phase 2 in this population ended, and files it under adverse-event reports rather than under clinical evidence, footnoting two internet reports rather than a publication.[1][13] Reported by FDA as anecdotal, and repeated here as that: "[a] total of 192 subjects with HIV lipodystrophy were enrolled and randomized" to weekly injections of an escalating low dose, an escalating high dose, or placebo; two hours after an eleventh weekly dose, "one subject complained of chest discomfort, and an ECG confirmed an acute myocardial infarction. The subject died approximately one hour later." FDA records the attending physician's most likely explanation as asymptomatic coronary artery disease with plaque rupture and occlusion, and states: "The study was terminated, and the data from that study has not been published. No further information about the other study subjects or about AEs was available."[1]

pepmg cannot confirm that FDA's anecdotal account and the registry record describe the same study — the enrollment figures differ (192 against 120) and the described populations are worded differently, and no publication exists to reconcile them.[1][11] What can be said from the registry alone is narrower and still striking: the only CJC-1295 trial ever registered was stopped, and its results were never reported.[11]

Two searches of the passive-surveillance systems came back close to empty, which is a finding about the systems as much as about the substance. FDA's Office of Surveillance and Epidemiology searched FAERS through June 10, 2024 and retrieved two reports, both excluded — one for insufficient information to assess, one because no adverse event was reported — and a literature search for domestic case reports "did not retrieve any relevant domestic case reports."[1] A CAERS search covering 2004 to April 2024 returned no cases.[1] Research-market use is not reported anywhere that a surveillance database can see it.

Safety

What the volunteers reported, and what has never been studied

The human adverse-event profile comes almost entirely from Teichman's two trials, and it is not subtle. In study 1, adverse events were reported in 33 of 35 subjects (94%) receiving the compound against two of seven (29%) on placebo.[1] Injection site reactions — irritation, erythema, induration, pain or itching — occurred in approximately 70% of dosed subjects and rarely on placebo; transient urticarial rashes at the injection site in almost 30%; headache in 63% against 14% on placebo; diarrhea in 43%; and systemic vasodilatory reactions, described as flushing, warmth and transient hypotension, in 30%, none of them in the placebo group.[1] In study 2, injection site reactions were reported in every subject who received the compound, flushing was dose dependent and reached 100% after high-dose injections, and single subjects experienced transient involuntary leg muscle contractions with some loss of coordination, or dizziness and hypotension.[1] Ionescu and Frohman reported no serious adverse events, with a dose-dependent increase in heart rate and injection-site redness and tenderness.[1][7] Teichman's paper concludes that the compound "was safe and relatively well tolerated, particularly at doses of 30 or 60 microg/kg."[6]

FDA's reading of the same numbers is the one that has held up: "[a]lthough two of the literature articles reviewed did not report major AEs with use of CJC-1295 DAC …, these studies were in healthy adults and most of the study subjects only received one dose."[1] It notes there is no safety information at all on use in children, that the substance was nominated to treat a chronic condition on a record of short exposures, and that because these compounds raise growth hormone and IGF-1 they plausibly carry the risks already printed in the labels of approved recombinant growth hormone products — increased risk of neoplasm, glucose intolerance and diabetes, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, slipped capital femoral epiphysis, progression of scoliosis and pancreatitis.[1] FDA states it "has not identified data or information to suggest" that the CJC-1295 substances would not present similar risks.[1]

Animal and in vitro data, labeled as such: FDA reports that in nonclinical toxicology studies of CJC-1295 DAC, "local injection site safety signals characterized by hemorrhage, inflammation, and necrosis were consistently observed in rats and dogs treated with repeated daily SC injections" at doses of 0.25 mg/kg and above for up to 14 days; that CJC-1295 DAC "generated genotoxic safety signals in vitro (in primary cultures of mouse pituitary cells) and in vivo"; and that because no carcinogenicity studies exist, the potential for pituitary hyperplasia and tumours from long-term overstimulation of somatotrophs "cannot be ruled out."[1] FDA also states that no nonclinical toxicity studies were identified for CJC-1295 free base or CJC-1295 acetate at all — the forms most of the market sells.[1] The published animal efficacy work is likewise about the DAC form: rats in 2005, and a growth-hormone-releasing-hormone knockout mouse in 2006.[9][10] None of this paragraph is human data, and none of it establishes harm in people.

One more concern in FDA's file is specific to peptides and specific to this one. Because CJC-1295 shares 86% homology with endogenous GHRH, FDA raises the possibility that antibodies raised against the injected peptide could cross-react with the body's own hormone, and notes that the one antibody assessment in the literature — Teichman's report of no significant antibody formation — came from subjects "most of whom were exposed … once," with no description of the assay's sensitivity or validation.[1]

The vote

Five substances, five separate votes, one yes

On December 4, 2024, FDA brought the CJC-1295 substances to the Pharmacy Compounding Advisory Committee alongside AOD-9604 and thymosin alpha-1.[2][4] The list at stake is a narrow one: the 503A Bulks List is the register of bulk substances a licensed pharmacist or physician may compound with when no applicable pharmacopeial monograph exists and the substance is not a component of an approved drug.[14][5] FDA's position going in was already on the record: its evaluation concluded that "a balancing of the criteria weighs against" placing any of the five on the 503A Bulks List, and the briefing package listed five separate proposals to exclude them.[1][5]

The committee was first asked whether a single vote could cover all five. It said yes 12 to 1 — and because one member dissented, FDA took the votes separately, which is why there is an unusually granular record.[2]

Vote tallies as recorded in the final summary minutes, approved February 21, 2025. Each question asked whether the substance should be placed on the list, against FDA's proposal that it not be; a "no" is a vote to exclude.[2]

An advisory vote is advice. It is not an approval, not a ban, and not a final rule — FDA's own briefing document says the agency "will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized."[5] What the vote does settle is the state of the evidence as thirteen outside experts read it, on a day when the substances' own nominators had already withdrawn their nominations.

"Removed from Category 2" does not mean what it is being sold as

A second regulatory fact about CJC-1295 circulates in a friendlier form than it deserves. The substance no longer appears in FDA's active Category 2 table of bulk substances that may present significant safety risks. It appears instead in a table further down the same FDA page, headed "Bulk drug substances nominated but withdrawn" — described there as substances "previously in category 2 of the interim policies [that] were withdrawn by the nominators."[3]

FDA's safety language travelled with it, unedited. The current entry for CJC-1295 on that page reads, in part: "FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited."[3] The evaluation footnotes the withdrawals by docket number and states that FDA elected to proceed with the presentation anyway, "evaluating the substances at its discretion."[1] A nomination being withdrawn is a change in who is asking. It is not a change in what FDA found.

Nothing in the compounding lane touches the research market anyway, and the approved-drug lane is empty in a specific way: FDA notes that among growth hormone secretagogues, only sermorelin (Geref, NDA 020443) was ever approved, for short stature associated with GHD in a preselected pediatric subpopulation, and that "[t]here are no GHSs that have been approved for the treatment of either adult- or childhood-onset GHD in adults."[1][15] Separately, and independently of any of this, the 2026 Prohibited List names CJC-1295 explicitly at section S2.2.4, among the growth hormone releasing factors inside the peptide hormones class it prohibits.[16][17]

Where the literature is now

No new human trial has appeared. What 2026 has produced is review articles, several of them, written by clinicians who are meeting patients already using these compounds. A narrative review in Frontiers in Endocrinology in June 2026 groups CJC-1295 with DAC and CJC-1295 without DAC among performance-enhancing peptides "marketed as 'research compounds'", and describes its own method as stratifying peptides "into evidence tiers from regulatory-grade randomized trial data to a complete absence of human studies."[18] That is a narrative review, not new data, and it is cited here for its framing rather than for any finding.[18] A registry search on August 28, 2026 still returns one interventional CJC-1295 study, the terminated 2005 one.[12]

Three things this note is not saying

First, it is not saying CJC-1295 does nothing. The pharmacodynamics are real and were measured properly: subcutaneous CJC-1295 DAC raised growth hormone and IGF-1 in healthy adults for days after a single injection, in randomized placebo-controlled trials with a published half-life.[6][7] Raising a hormone is not the same as producing a clinical benefit, and no study has taken the second step.[1]

Second, it is not saying the compound has been shown to be dangerous in people. The human safety record is short exposures in healthy volunteers with a high rate of injection-site and vasomotor reactions, one anecdotally reported death in a terminated trial that was never published, and essentially nothing in the passive surveillance systems.[1] That is not a demonstration of harm. It is an absence of the data that would settle it either way, on a substance sold for chronic use.[1]

Third, it is not saying vendors are mislabelling anything. Most of them do state the form: 160 of 177 listings name DAC or no-DAC on the product page.[19] The gap is not that the market hides the distinction. It is that the market discloses the distinction while the evidence that gets quoted alongside it belongs to the other molecule.[1][19]

What it is saying is narrow enough to check: the published human evidence for CJC-1295 is three studies in 63 healthy volunteers, measuring hormone levels rather than outcomes, and it appears to belong to the DAC form.[1] The form sold on 103 of 177 listings in this index is the one FDA could not find a human study of.[1][19]

Questions people are asking