CJC-1295

CJC-1295 DAC

Grade B: Human evidence, not approved for this use

TL;DR: CJC-1295 (with DAC) is a synthetic analog of growth hormone-releasing hormone (GHRH) engineered with a drug affinity complex modification that enables albumin binding, extending its plasma half-life from minutes to days. The human evidence base is narrow: a single pharmacodynamic RCT in healthy adults (PMID 16352683) demonstrated that CJC-1295 produced dose-dependent, sustained increases in serum GH (2-10 fold) and IGF-1 (1.5-3 fold) persisting for 9-11 days after a single dose. This is a pharmacodynamic study, not a therapeutic efficacy trial for any clinical indication; no published RCT has evaluated CJC-1295 for a patient health outcome. Netnographic and gray-market use evidence shows widespread off-label use in fitness and anti-aging contexts, but no controlled clinical benefit data exist for these applications. The evidence base justifies a pharmacological Grade B but does not support claims of therapeutic efficacy for any condition.

Key Takeaways

Grade B: Human evidence, not approved for this use
Not FDA approved: Not FDA-approved for any indication; removed from Category 2 compounding restriction April 2026, pending formal PCAC review and rulemaking for potential Category 1 placement.
Compounding: The nomination to add CJC-1295 to the FDA 503A or 503B bulk-substances list was withdrawn; it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding.

CJC-1295 chemical structure — Structure via PubChem CID 91971820

Mechanism

CJC-1295 binds and activates the GHRH receptor on pituitary somatotroph cells, stimulating pulsatile GH secretion; albumin binding via the DAC modification extends the half-life to approximately 8 days, producing sustained GH and downstream IGF-1 elevation.

Evidence

CJC-1295 (with DAC) is a synthetic analog of growth hormone-releasing hormone (GHRH) engineered with a drug affinity complex modification that enables albumin binding, extending its plasma half-life from minutes to days. The human evidence base is narrow: a single pharmacodynamic RCT in healthy adults (PMID 16352683) demonstrated that CJC-1295 produced dose-dependent, sustained increases in serum GH (2-10 fold) and IGF-1 (1.5-3 fold) persisting for 9-11 days after a single dose. This is a pharmacodynamic study, not a therapeutic efficacy trial for any clinical indication; no published RCT has evaluated CJC-1295 for a patient health outcome. Netnographic and gray-market use evidence shows widespread off-label use in fitness and anti-aging contexts, but no controlled clinical benefit data exist for these applications. The evidence base justifies a pharmacological Grade B but does not support claims of therapeutic efficacy for any condition.

Safety and risks

Long-term human safety data for CJC-1295 do not exist; the single published human RCT was short-duration and enrolled healthy volunteers only. Sustained, pharmacologically induced elevation of GH and IGF-1 raises a well-characterized theoretical concern: IGF-1 is a mitogenic, anti-apoptotic, and angiogenesis-promoting factor, and chronically elevated IGF-1 is associated in epidemiological literature with increased proliferative risk in hormone-sensitive tissues (colon, thyroid, prostate), consistent with elevated cancer incidence data in acromegaly. This is a theoretical risk at pharmacological GH-stimulating doses; a direct causal link for CJC-1295 specifically has not been established in any trial. Injection site reactions are expected. Patients with a history of pituitary tumors, active malignancy, or acromegaly should not use GH-axis stimulants. Water retention, joint discomfort, and insulin resistance are class effects associated with GH excess. A 2006 Phase 2 trial in HIV-associated lipodystrophy was halted after a participant died approximately two hours after the 11th injection; causation was disputed and attributed by investigators to pre-existing coronary artery disease rather than the study drug, but the event has not been formally adjudicated and is part of the compound's clinical history. The Pharmacy Compounding Advisory Committee (PCAC) in December 2024 cited cardiac-adjacent effects (tachycardia, flushing, hypotension) and broader nonclinical signals (DNA damage in pituitary cells, injection site necrosis, hemoglobin reduction) as part of its rationale for Category 2 placement; a confirmed cardiac adverse event was not established.

Interactions

May reduce insulin sensitivity and interact pharmacodynamically with insulin or oral antidiabetic agents; concurrent use with other GH-axis stimulants (GHRPs, growth hormone itself) produces additive GH/IGF-1 elevation with compounded and uncharacterized risk.

Federal compounding status

Nomination withdrawn (was Category 2) as of 2026-06-02.

This substance was nominated for the FDA 503A or 503B bulk-substances list and previously sat in the Category 2 (significant safety risk) group; the nomination was later withdrawn, so it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding. FDA source

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

The nomination to add CJC-1295 to the FDA 503A or 503B bulk-substances list was withdrawn; it is not on an active FDA bulks list and is not eligible for routine pharmacy compounding.

Sources

CJC-1295 is Not FDA approved. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).