CJC-1295 official evidence assessment · version 1
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What does the official evidence assessment say?
FDA assessment dated November 15, 2024 · Read September 15, 2026 · Preserved version 1
FDA's dated evaluation of five CJC-1295-related bulk substances. The briefing distinguishes DAC and non-DAC forms and is an advisory-stage assessment, not a final compounding rule. FDA document ↗
Which human evidence applies?
FDA describes the published studies as short studies of DAC forms in healthy adults. It identifies the 2009 proteomic report as a subset of the earlier Ionescu and Frohman study, rather than an independent participant cohort. FDA pp. 40, 42 ↗
What adverse effects were reported?
FDA reports injection-site reactions, headache, flushing and transient blood-pressure changes in the early studies. Limited exposure in healthy adults cannot establish longer-term safety or safety in growth hormone deficiency. FDA pp. 40, 41, 42 ↗
Why the terminated trial matters
FDA cites anecdotal reports of a death during a terminated HIV-lipodystrophy trial and states that its results were unpublished. This is an agency account of those reports, not proof that CJC-1295 caused the death. FDA pp. 40 ↗
Scope, source pin and remaining work
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
Source: FDA evaluation of five CJC-1295-related bulk substances, November 15, 2024. SHA-256: 202fa022933ef27241c6e19f2156ca764854ccf4a7286e0fe1f1b6b56df39506.