Study record · CJC-1295 (with DAC)
FDA evidence review of CJC-1295-related compounded substances
FDA states available clinical data are limited and has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic.
Key result
FDA states available clinical data are limited and has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction.
Study details
Study designRegulatory safety evidence review
PhaseRegulatory
PopulationPublished healthy-adult clinical studies plus other exposure reports
Sample sizeNot applicable
RoutePrimarily injectable evidence
Regimen / exposureEvidence audit rather than a therapeutic regimen
DurationNot applicable
ComparatorNot applicable
Primary endpoint / questionHuman safety information and formulation uncertainty
Safety resultLong-term repeated-exposure safety and immunogenicity remain inadequately characterized.
Key limitationsFDA notes ambiguity about the exact CJC-1295 substance/salt used in some literature; results cannot be transferred across DAC/no-DAC marketplace labels.
Registry / identifierFDA compounding safety review