CJC-1295
Originally developed by ConjuChem, CJC-1295 is a tetrasubstituted 29-amino-acid analog of GHRH(1-29); the DAC (Drug Affinity Complex) version binds serum albumin to extend its half-life to roughly 6-8 days. Available human evidence is limited to early-phase pharmacokinetic/pharmacodynamic data showing raised GH and IGF-1; no efficacy or long-term safety has been established.
Mechanism
In plain terms it tells the pituitary gland to release more of the body's own growth hormone. Technically, it binds the GHRH receptor (a Gs-coupled G-protein-coupled receptor) on anterior-pituitary somatotrophs, raising intracellular cAMP and activating protein kinase A to stimulate both synthesis and pulsatile release of endogenous growth hormone, which secondarily raises IGF-1. Four amino-acid substitutions (D-Ala2, Gln8, Ala15, Leu27) resist enzymatic degradation, and in the DAC version a lysine-linked maleimidopropionamide moiety forms a covalent bond with cysteine-34 of albumin, extending the half-life from minutes to about a week (Teichman et al., 2006).
Regulatory Status by Region
- United States (FDA)Not approved for any indication and never marketed. FDA placed CJC-1295 in Category 2 (potential significant safety risk) of the interim 503A bulk drug substances list; the nomination was later withdrawn/removed and the Pharmacy Compounding Advisory Committee did not recommend it for the 503A bulks list.
- Australia (TGA)Not on the Australian Register of Therapeutic Goods (ARTG); an unapproved GHRH analog. Supply for human therapeutic use is restricted (prescription-only class of substance) and no obesity/GH indication is approved.
- European Union (EMA)No EMA marketing authorization; not an approved medicine in the EU.
- WADAProhibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); GHRH analogues including CJC-1295 are explicitly listed.
Key Studies
- 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 (Teichman SL, Neale A, Lawrence B, et al. J Clin Endocrinol Metab. 2006;91(3):799-805. PMID 16352683)
- Once-daily administration of CJC-1295, a long-acting GHRH analog, normalizes growth in the GHRH knockout mouse (Alba M, Fintini D, Sagazio A, et al. Am J Physiol Endocrinol Metab. 2006 (preclinical). PMID 16822960)