CJC-1295 is discussed for growth-hormone release, body composition, recovery, and healthy aging.
A healthy-volunteer study showed hormone changes, not clinical benefit for growth hormone deficiency; FDA also treats DAC and no-DAC forms as distinct active moieties.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
6 names in this peptide family.
CJC-1295 and CJC-1295 DAC are distinct active moieties; free-base, acetate, and trifluoroacetate substances retain their exact form and are not treated as interchangeable.
4 evidence questions.
Human benefitLimited human evidenceDoes CJC-1295 have established human clinical benefit for growth hormone deficiency?
FDA approvalNo FDA approval identifiedIs CJC-1295 FDA approved?
503A statusRegulatory recordIs CJC-1295 on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled CJC-1295 automatically interchangeable?
See every CJC-1295 evidence question →Open the machine-readable record ↗PCAC did not recommend the five CJC-1295-related substances
Votes were 0–13 for most reviewed forms and 1–12 for CJC-1295 acetate; none received a favorable recommendation.
FDA received an unfavorable expert recommendation across the separately reviewed forms.
The votes were non-binding and did not themselves create a final legal change.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
PCAC did not recommend the five CJC-1295-related substances
Votes were 0–13 for most reviewed forms and 1–12 for CJC-1295 acetate; none received a favorable recommendation.
Read the source ↗FDA completed its scientific briefing
FDA evaluated five distinct CJC-1295 and CJC-1295 DAC bulk drug substances for growth hormone deficiency.
Read the source ↗CJC-1295 entered FDA's 503A nomination record
Nominations described CJC-1295-related substances inconsistently. They were later withdrawn, and FDA evaluated five distinct substances on its own initiative.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
Long-acting CJC-1295 increased growth hormone and IGF-I in healthy adults. The study measured hormone responses, not clinical benefit in people with growth hormone deficiency, and it should not be generalized to every no-DAC or salt form.
Read the study on PubMed ↗A preclinical study characterized the long-acting DAC analog's binding and hormone effects. It does not establish patient benefit or interchangeability with CJC-1295 without DAC.
Read the study on PubMed ↗Important unknowns.
- FDA identified serious adverse events including increased heart rate and a systemic vasodilatory reaction in the reviewed record.
- CJC-1295 without DAC and CJC-1295 DAC are different active moieties; salts and forms also remain distinct substances.
- A short healthy-volunteer hormone study does not establish clinical benefit for growth hormone deficiency.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
3 dated changes. 0 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.