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Regulatory evidence 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 vasodilatory reaction.

Quick read
Regulatory evidence record

What this study tells us

This is a regulator evidence review, not a participant treatment trial. It is useful for showing what human exposure or safety evidence the regulator could — or could not — identify.

Who was studied?

Published healthy-adult clinical studies plus other exposure reports

How many?

n=Not applicable

What happened?

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.

What stops us overclaiming?

FDA notes ambiguity about the exact CJC-1295 substance/salt used in some literature; results cannot be transferred across DAC/no-DAC marketplace labels.

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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