CJC-1295
/ Tetrasubstituted GHRH(1-29) analog; DAC variant covalently binds albumin for extended half-lifeALIAS · CJC-1295 with DAC · CJC-1295 without DAC
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Never advanced past Phase 2 in human development. Phase 1 endocrine pharmacology is the only substantive human data. 503A Category 2 — do not compound.
CJC-1295 without DAC is a tetrasubstituted GHRH(1-29) analog (modified amino acids D-Ala2, Gln8, Ala15, Leu27) with half-life on the order of 30 minutes. CJC-1295 with DAC adds a drug-affinity-complex maleimidopropionic-acid moiety that covalently binds albumin in vivo, extending plasma half-life to approximately 6-8 days and producing sustained GHRH-receptor stimulation with a bleed of GH and IGF-1 rather than pulsatile release.
No pivotal trials exist. The original ConjuChem program was halted after an unexplained cardiac death signal in a Phase 2 obesity trial around 2007 (causality disputed). Only Phase 1 endocrine-pharmacology data (Teichman 2006) is in the peer-reviewed literature.
Phase 1 adverse events were mild (injection-site reactions, transient flushing, headache). A cardiac event in a Phase 2 obesity trial (reported in ConjuChem press materials in 2007, unpublished) led to development discontinuation. Long-term safety is unknown.
Regulatory status
- FDA status:
- Not FDA-approved
- Compounding:
- 503A Category 2 — do-not-compound pending review
FDA’s 2023 503A bulk drug substance evaluation placed CJC-1295 in Category 2. Compounding by 503A pharmacies is generally not permitted. FDA has issued warning letters regarding compounding of CJC-1295 and CJC-1295/ipamorelin blends. Sustained non-pulsatile GH/IGF-1 elevation with the DAC form deviates from physiologic GH pulsatility in a way whose long-term endocrine consequences are not established.