CJC-1295
Also sold as: CJC 1295, CJC-1295 with DAC
CJC-1295 has no approved FDA application for any indication and cannot lawfully be used in 503A compounding: it appears in none of the three categories of the FDA 503A bulks list, and FDA lists it under 'Bulk drug substances nominated but withdrawn' — the nominators withdrew the nomination, which left CJC-1295 off the list exactly as before rather than moving it toward legality. Researchers did administer CJC-1295 to healthy adults in 2006, subcutaneously and in ascending doses, and reported dose-dependent rises in growth hormone and IGF-I (PMID 16352683), but every endpoint those trials measured was a hormone concentration, and the only registered trial designed to evaluate efficacy — ConjuChem's Phase 2 in HIV-associated visceral obesity — was terminated without posting results, so no efficacy trial of CJC-1295 has ever reported an outcome.
Which molecule this is. CJC-1295 as characterised in the literature is a tetrasubstituted form of human growth-hormone-releasing factor hGRF(1-29) carrying an added C-terminal lysine bearing an N-epsilon-3-maleimidopropionamide group, which bioconjugates in vivo to the free thiol on Cys34 of serum albumin — that albumin conjugation is the entire point of the molecule (Endocrinology 2005, PMID 15817669, in which the researchers reported CJC-1295 present in rat plasma beyond 72 h and an immunoreactive species on the serum-albumin band). The multi-day figure in humans is separate and comes from the 2006 healthy-adult trial, where the investigators estimated a half-life of 5.8-8.1 d (PMID 16352683); the 2005 paper is rat pharmacokinetics and does not establish it. What is sold under the name is not reliably that molecule. A preparation of unknown origin, submitted for analysis at the request of Norwegian police and customs authorities and analysed by LC-HRMS/MS, was reported to contain a 29-amino-acid peptide with a C-terminal amide function, which the authors state is 'consistent with a peptide currently marketed under the name CJC-1295' (Drug Test Anal 2010, PMID 21204297) — a 29-residue amidated peptide does not carry the added C-terminal maleimido-lysine. We record the juxtaposition, not an identification: neither paper adjudicates the other. The market convention of calling the albumin-binding form 'with DAC' and the short-acting form 'without DAC' has no FDA or literature standing, and FDA's own listing says only 'CJC-1295' without qualifying which molecule it means.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”Checked against the source on .
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
The withdrawal is established by THIS document, not by the bulks list. FDA's category-2 page carries CJC-1295 in the table under the heading 'Bulk drug substances nominated but withdrawn', which the page defines with the quoted sentence. That is what supports the value. Separately, CJC-1295 is absent from Categories 1, 2 and 3 of the 503A bulks list updated 2026-05-14 — verified by fetching and text-extracting that document directly; the string 'CJC' does not appear in it at all — but absence alone would establish only absence, and could not distinguish withdrawn from never-nominated. It is therefore NOT category-2, and this is not a legalisation event: CJC-1295 did not enter Category 1, is not on the 503A bulks list, and remains non-compoundable. Status moved sideways.
“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
ADMINISTRATION CHECK RUN, AND IT PASSES — which is the opposite of the MOTS-c and TB-500 outcome, and the reason this record is not animal-or-in-vitro-only. Both human papers were opened and read. In the 2006 trial (PMID 16352683, healthy adults aged 21-61, two randomised placebo-controlled double-blind ascending-dose trials of 28 and 49 days), researchers state CJC-1295 was administered subcutaneously and report dose-dependent increases in mean plasma GH and IGF-I. In a second 2006 study (PMID 17018654, healthy men aged 20-40), researchers report increased trough and mean GH secretion with preserved pulsatility after a single injection. The drug was given to people; it was not measured as an endogenous biomarker. WHY IT IS STILL UNPROVEN. Every endpoint in both papers is a hormone concentration — the 2006 trial's stated main outcome measures are 'peak concentrations and area under the curve of GH and IGF-I'. Neither study measured a clinical outcome. Raising IGF-I is a pharmacodynamic effect, not a demonstration of benefit, and the authors' own conclusion claims only that the data 'support the potential utility of CJC-1295 as a therapeutic agent'. The one trial designed to evaluate efficacy — NCT00267527, ConjuChem's randomised double-blind placebo-controlled Phase 2 in HIV-associated visceral obesity, 12 weeks, registered enrolment 120 — has overall status TERMINATED on ClinicalTrials.gov, verified against the registry API on 2026-07-16. The registry does not state whether that 120 is anticipated or actual, and for a terminated trial those are very different numbers, so it is reported here as the registered figure and nothing more. Its record carries no results and no outcome measures at all, its last update was posted 2006-10-16, and the registry record carries no why-stopped information, so the reason it stopped is not publicly known and we will not speculate. No efficacy trial of CJC-1295 has ever reported a result. Zero trials of it are indexed for any marketed use — body composition, recovery, sleep, anti-aging. REGISTRY HYGIENE. The CJC-1295 registry search returns exactly one study, sponsored by the developer in 2005. None of the 2026 single-sponsor 'Hudson Biotech' registrations contaminating this vertical touch this compound.
“CJC-1295 or placebo was administered sc in one of four ascending single doses in the first study and in two or three weekly or biweekly doses in the second study.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
CJC-1295 appears in none of the three categories of the 503A bulks list updated 2026-05-14. It may not lawfully be used in 503A compounding for any use.
Recorded as its own finding because absence from a list establishes only absence. It carries the legal consequence — a substance not on the list is not available for 503A compounding, which follows from the absence itself — but it does NOT establish WHY CJC-1295 is absent. The withdrawal is established by the category-2 page below, not here.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .FDA lists CJC-1295 under 'Bulk drug substances nominated but withdrawn' — substances previously in category 2 of the interim policies whose nominations the nominators withdrew — and continues to publish the potential significant safety risks it identified for it.
The withdrawal removed the nomination, not the findings. FDA kept the safety text published on the same page after the substance left category 2, which is the fact that 'it's off the Category 2 list now' coverage omits.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”
Checked against the source on .FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction, and states that available clinical data are limited.
This finding sits in direct tension with the published trial, and readers should see both. The 2006 healthy-adult trial reports 'No serious adverse reactions were reported' (PMID 16352683). FDA, reviewing the nomination, says it identified serious adverse events. We cannot reconcile these from public documents: FDA's page does not cite the source, dates, route, number of cases, or molecule for the events it describes, and does not state whether it is drawing on trial data, FAERS, or post-marketing reports. Recording only the trial line would understate the risk; recording only FDA's line would imply a case series that we have not seen. Both are recorded verbatim and the gap is left open.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited.”
Checked against the source on .FDA states that compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization.
Quoted as printed, including the 'with regard to for' typo in FDA's own text. This is a finding about the SUBSTANCE AS COMPOUNDED — identity, purity and characterisation of the material in the vial — not about the pharmacology. It is the concern that the unknown-preparation analysis (PMID 21204297) makes concrete.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to for peptide-related impurities and API characterization.”
Checked against the source on .Drugs@FDA, FDA's database of approved drug products, returns no matches for CJC-1295. There is no approved application for CJC-1295 for any indication or route.
The quote is the API's verbatim response body, not prose about it — which is the only honest way to cite an absence. Queried on generic name, active-ingredient name and brand name; all three return the same. The claim is deliberately narrow: it establishes that no approval EXISTS, not that FDA ever reviewed and refused one. Those are different facts and only the first is in evidence. CJC-1295 never reached an application — the developer's only clinical-endpoint trial was terminated in 2006 (NCT00267527) and development stopped there.
Drugs@FDA — approved drug products database, queried for CJC-1295 (openFDA) — FDA, 16 July 2026“No matches found!”
Checked against the source on .FDA states that it identified the potential significant safety risks it publishes for CJC-1295 in the course of reviewing the nomination to add it to the 503A or 503B bulks lists.
Recorded because it situates the CJC-1295 safety text, which the entry itself does not. It does not DATE it: the 'nominated but withdrawn' table has only two columns, 'Bulk drug substance' and 'Potential significant safety risks'. The 'Date added to category 2' column belongs to the separate category-2 table, so no date is available for the CJC-1295 entry from this page. The findings are the OUTPUT OF A NOMINATION REVIEW — FDA reviewing the case made for putting this substance on the list — not the output of a post-marketing surveillance programme or an approval review. That framing is what makes FDA's retention of the text after the nomination was withdrawn worth noting: the review that produced it is over, the nominator is gone, and FDA still publishes the risks.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has identified potential significant safety risks when reviewing nominations for bulk drug substances proposed to be included on the sections 503A or 503B bulks lists.”
Checked against the source on .
Documented safety signals
Increased heart rate and systemic vasodilatory reaction, characterised by FDA as serious adverse events associated with CJC-1295.
Attributed to FDA, which is the only body that has stated it. Route, dose, molecule (albumin-conjugating form or not), case count and source of the reports are all unstated on FDA's page; we did not find a document that supplies them.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction.”
Checked against the source on .A peptide marketed as CJC-1295 has been sold illicitly and analysed as an unknown preparation by forensic authorities. The authors state that, as a releasing factor for growth hormone, CJC-1295 is considered a Prohibited Substance under Section S2 of the WADA Prohibited List — the list as it stood when they wrote in 2010.
Included as an identity/sourcing signal rather than a pharmacological one: what a vial labelled CJC-1295 contains has been an open question since at least 2009, and the authors reached their sequence by interpreting mass-spectrometric data from a preparation of unknown origin. On the WADA classification the paper says only 'the WADA Prohibited List', with no year attached; the 2010 attribution in the value above is ours, from the paper's publication date, and is marked as such rather than put in the authors' mouths. It matters because the WADA Prohibited List is revised annually and a 2010 paper cannot support a present-tense claim about the current one. Anyone subject to testing should check the current list rather than rely on this record.
Identification of CJC-1295, a growth-hormone-releasing peptide, in an unknown pharmaceutical preparation — PubMed, 1 November 2010“Several peptide drugs are being manufactured illicitly, and in some cases they are being made available to the public before entering or completing clinical trials.”
Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is CJC-1295 legal in 2026?
CJC-1295 is not on the FDA 503A bulks list, which means it cannot lawfully be used as a bulk drug substance to compound drug products under section 503A. Verified against the list as updated 2026-05-14: CJC-1295 appears in none of the three categories, and the string 'CJC' is absent from the document entirely. CJC-1295 also has no approved FDA application for any indication.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .- Did CJC-1295 become legal again when FDA removed it from Category 2?
No. CJC-1295 leaving category 2 was not a legalisation event, and it was not a decision by FDA that the substance is acceptable. FDA's own page explains what happened: the substances previously in category 2 of the interim policies were withdrawn by the nominators. A nomination is a request to ADD a substance to the 503A bulks list, so withdrawing it leaves CJC-1295 off that list exactly as before — off the list means not usable in 503A compounding. FDA continues to publish, on that same page, the potential significant safety risks it identified for CJC-1295. The nomination went away; the findings did not.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.”
Checked against the source on .- Did FDA approve CJC-1295?
No. There is no FDA-approved drug product containing CJC-1295 for any indication or route of administration — Drugs@FDA, FDA's database of approved applications, returns no matches for it. CJC-1295 never reached an approval application: the only clinical trial of CJC-1295 ever registered on ClinicalTrials.gov, a Phase 2 study sponsored by its developer ConjuChem, was terminated and posted no results.
Drugs@FDA — approved drug products database, queried for CJC-1295 (openFDA) — FDA, 16 July 2026“No matches found!”
Checked against the source on .- Is there any human evidence that CJC-1295 works?
There are human trials of CJC-1295, but none of them measured whether it helps anyone. In two randomised, placebo-controlled, double-blind ascending-dose trials published in 2006 (PMID 16352683, healthy adults aged 21-61, 28 and 49 days), researchers administered CJC-1295 subcutaneously and reported dose-dependent increases in mean plasma growth hormone and IGF-I. The trials' own stated main outcome measures were peak concentrations and area under the curve of GH and IGF-I — hormone levels, which are a pharmacodynamic effect rather than a clinical benefit. The authors concluded only that their data support the potential utility of CJC-1295 as a therapeutic agent. No trial of CJC-1295 has ever reported a clinical outcome, and none is indexed for the uses it is marketed for.
Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults — PubMed, 1 March 2006“The main outcome measures were peak concentrations and area under the curve of GH and IGF-I; standard pharmacokinetic parameters were used for CJC-1295.”
Checked against the source on .- Was CJC-1295 ever tested in patients rather than healthy volunteers?
Once, and it did not finish. ConjuChem registered a randomised, double-blind, placebo-controlled Phase 2 trial of CJC-1295 in HIV patients with visceral obesity (NCT00267527, 12 weeks, registered enrolment 120 — the registry does not state whether that is the anticipated or the actual number, and the trial did not finish). Its registered title describes it as a study 'to Evaluate the Efficacy and Safety of CJC 1295'. Its overall status on ClinicalTrials.gov is TERMINATED, it posted no results, and its last update was in October 2006. The registry record carries no why-stopped information, so the reason it was terminated is not publicly known. It is the only trial of CJC-1295 registered on ClinicalTrials.gov.
A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity (NCT00267527) — ClinicalTrials.gov, 16 October 2006“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”
Checked against the source on .- Is CJC-1295 safe?
Unknown, and the two public records disagree. FDA states 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. The 2006 healthy-adult trials report the opposite experience — no serious adverse reactions were reported (PMID 16352683). These cannot be reconciled from public documents: FDA does not state the source, dates, route, case count or molecule for the events it describes. Separately, FDA states that compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and API characterization — a concern about what is in the vial, which a forensic analysis of a preparation sold as CJC-1295 (PMID 21204297) makes concrete.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited.”
Checked against the source on .