What It Is
CJC-1295 DAC is a long-acting analogue of growth hormone-releasing hormone (GHRH). Its Drug Affinity Complex includes an albumin-binding modification intended to prolong exposure.[1]
FDA's 2024 review identified two different active moieties and at least five distinct CJC-1295-related bulk substances, including multiple DAC salts. Names, identifiers, certificates, and clinical citations were often inconsistent. Evidence cannot safely be transferred between DAC, no-DAC, free-base, acetate, and TFA forms.[1]
What Human Studies Measured
Small controlled studies in healthy adults found prolonged increases in growth hormone and IGF-1 after CJC-1295 DAC exposure; one study estimated a half-life of roughly 5.8 to 8.1 days, and another found that pulsatile secretion persisted.[2][3] FDA noted that the exact salt was not specified, although the active moiety appeared to be the DAC form.
These are pharmacokinetic and biomarker findings. They do not establish better muscle mass, fat loss, recovery, longevity, or clinical treatment of growth hormone deficiency.
Effectiveness Evidence
FDA found only three published human studies, all in healthy adults, and no study in people with a disease or condition. No human effectiveness evidence established CJC-1295 DAC for growth hormone deficiency or another indication.[1]
People with complete growth hormone deficiency may not respond to a secretagogue in the way healthy volunteers do. Results from volunteers with an intact hypothalamic-pituitary axis therefore cannot be treated as treatment evidence.
Safety and Unknowns
Across 63 healthy adults in the published studies, most received only one injection. Reported effects included frequent injection-site reactions, headache, diarrhea, flushing or warmth, transient hypotension, nausea or abdominal pain, dizziness, increased heart rate, and other short-lived neurologic symptoms. The sample size and exposure duration were inadequate for rare or long-term risks.[1]
An unpublished phase 2 HIV-lipodystrophy study was terminated after a participant experienced a fatal myocardial infarction after an eleventh dose; the attending physician attributed the event to coronary plaque rupture, and the available record cannot establish drug causality. FDA also identified unresolved risks involving GH/IGF-1 stimulation, impurities, aggregation, immunogenicity, and long-term pituitary effects.[1][4]
Regulatory and Sport Status
No CJC-1295-related product is FDA-approved. FDA proposed not adding CJC-1295 free base, acetate, DAC free base, DAC acetate, or DAC TFA to the 503A Bulks List in 2024.[1] CJC-1295 is also covered by WADA's prohibition on growth hormone-releasing factors.[5]
Why DAC and No-DAC Must Stay Separate
The prolonged human biomarker findings belong to a DAC active moiety of incompletely specified salt form. FDA did not identify human studies of CJC-1295 free base or acetate without DAC. Calling both products simply CJC-1295 hides a clinically important identity problem.[1][2]