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Also: CJC 1295 · CJC-1295 DAC · CJC-1295 with DAC · DAC:GRF · drug affinity complex:growth hormone-releasing factor · GRF 1-29 modified with DAC · CJC-1259 · CJC1259 · CJ-1295
Four separate measurements, never averaged. Independent evidence counts only studies with no sponsor attached. Methodology version v2.0-2026-10 · how we grade evidence
Not approved by any regulator, anywhere, for any indication, and development was abandoned in 2006: the sponsor withdrew the compound from clinical trials after the death of a subject in a Phase 2 trial. FDA’s briefing states this plainly but does not state the cause of death, and the research package could not establish whether the death was attributed to the drug. Both the event and the uncertainty belong on the record; neither should be dropped.
Claims — stated as claims — include increased growth hormone and IGF-1, fat loss, lean muscle gain, improved sleep, better skin, "anti-aging" and faster recovery. It is very commonly sold blended with ipamorelin.
The unusual thing about this compound is that its biochemical mechanism is confirmed in humans while its clinical benefit is entirely unevidenced. A 2006 study in healthy adults showed sustained, dose-dependent elevation of growth hormone and IGF-1 after subcutaneous dosing. That is a pharmacodynamic finding with no disease endpoint. FDA’s 2024 review found three human studies in total, all in healthy subjects, and noted that none appears to have used a compounded formulation; the only trial ever run in a patient population terminated prematurely with no results. No human trial has ever shown a clinical outcome benefit for any condition. The 2026 sports-medicine scoping review found one human and one animal study within its scope, no human musculoskeletal trials, and injection site reactions in 70% of participants in a Phase 1 study.
FDA found no carcinogenicity studies; animal toxicology, available only as abstracts, reported reduced food intake, injection-site irritation, emesis and red-blood-cell decreases in rats and dogs, with genotoxicity signals in pituitary cells for an unspecified DAC form, and no nonclinical data at all for the free base and acetate. The longest reported human exposure is 49 days. FDA separately flagged the trifluoroacetate counterion form, noting that trifluoroacetate "is known to be toxic." In the grey-market survey 9.1% of CJC-1295 samples failed identity testing, median purity was 98.49% — second-lowest of fourteen peptides — and only 10.7% met a manufactured-drug benchmark.
A mislabelling problem specific to this compound: "Mod GRF (1-29)," "Modified GRF 1-29" and "CJC-1295 without DAC" are the DAC-free peptide, with a half-life of minutes rather than days. FDA treats them as distinct active moieties. The human pharmacodynamic data belong to the DAC form, and products sold as the DAC-free peptide borrow them. FDA formally evaluated five separate substances under this heading: free base, acetate, DAC free base, DAC acetate and DAC trifluoroacetate.
At a glance
A GHRH analogue that stimulates pituitary growth hormone release, with the DAC moiety binding albumin to extend half-life from minutes to days. Animal work confirmed secretagogue activity and slow clearance of the DAC form in rats and growth effects in GHRH-knockout mice. In humans the mechanism is demonstrated: a single subcutaneous dose raised mean plasma growth hormone 2- to 10-fold for six days or more and IGF-1 1.5- to 3-fold for nine to eleven days, with an estimated half-life of 5.8 to 8.1 days. What is not demonstrated in humans is that any of this translates into clinical benefit. Chronic elevation of growth hormone and IGF-1 also carries recognised class risks — insulin resistance, fluid retention, and in the case of IGF-1 theoretical neoplasm concerns — which can be read off the labelled warnings of tesamorelin, the one approved GHRH analogue.
Dated determinations, each flagged for whether it is final and whether it covers safety only. A safety review is not an efficacy finding, and most reporting in this category conflates the two.
Named alongside CJC-1293, sermorelin and tesamorelin as GHRH analogues; the same section names anamorelin, capromorelin, ibutamoren, ipamorelin, lenomorelin, macimorelin and tabimorelin as growth hormone secretagogues.
Votes on 4 December 2024, on the question "Should [X] be placed on the list?", where yes means add: free base 0 yes / 13 no; acetate 1 / 12; DAC free base 0 / 13; DAC acetate 0 / 13; DAC trifluoroacetate 0 / 13. It is not on the 503A Bulks List. At the same meeting the committee also voted down thymosin alpha-1, a different peptide, 4 yes / 17 no.
FDA evaluated five separate substances under this heading — CJC-1295 free base, acetate, DAC free base, DAC acetate and DAC trifluoroacetate — and treats CJC-1295 and CJC-1295 DAC as distinct active moieties. Its review found three human studies, all in healthy subjects, and noted "none of the studies appear to have used a compounded formulation of CJC-1295 DAC"; no human study has ever measured a clinical outcome in a disease population. FDA found no carcinogenicity studies; animal toxicology available only as abstracts reported reduced food intake, injection-site irritation, emesis and red-blood-cell decreases in rats and dogs, with genotoxicity signals in pituitary cells for an unspecified DAC form, while a rat developmental study found no maternal or embryofetal toxicity at the doses tested. No nonclinical data at all were found for the free base and acetate forms. FDA could not rule out immunogenicity for any of the five forms given subcutaneously because impurities and aggregates are inadequately characterised, and specifically flagged the trifluoroacetate counterion, noting that trifluoroacetate "is known to be toxic." The agency also documented reports of illicit use in sport. Separately and importantly: the sponsor withdrew CJC-1295 DAC from clinical trials in 2006 after the death of a subject in a Phase 2 trial. FDA’s briefing does not state the cause of death and causation was not established here.
One of the 19 substances added to Category 2 on 29 September 2023. It now appears only in the "nominated but withdrawn" table on FDA’s page, content current as of 22 April 2026, and it is not on the 503A Bulks List.
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