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Compound reference

CJC-1295 DAC

Peptides4 cited findingsClinical review: not reviewed

Identity & applicability

Regulatory recordSupporting passage inspected

FDA evaluates CJC-1295 without DAC and CJC-1295 with DAC as different active moieties. Salt and DAC identity must be specified before applying study findings; a half-life for a long-acting DAC preparation should not be attached to non-DAC products.[1]

  • Names used by vendors do not establish that a vial matches a studied formulation.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Fresh scoped source inspection; locator/date corrections and original full-text evidence recorded. Independent editorial review pending; no qualified clinical review.

· Independent editorial worker reopened the cited support; coordinator resolved the requested bibliography corrections and integrated the bounded claim. Original and corrected cell figures remain scientifically inconsistent as stated. No qualified clinical review.

Safety findings

Human randomized studySupporting passage inspected

Short healthy-volunteer studies of long-acting CJC-1295 reported injection-site reactions, headaches, gastrointestinal symptoms and transient vasodilatory or hypotensive reactions. The investigators reported no serious adverse reactions in those studies, which were too short and small to establish long-term safety.[2]

  • The DAC salt was not specified; results do not characterize non-DAC CJC or all products bearing the name.
  • A lack of serious events in these trials does not negate unpublished or later reports.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Fresh source inspection of specified original sections; proposed addition awaits independent editorial review.

· Independent editorial worker reopened the cited support; coordinator resolved the requested bibliography corrections and integrated the bounded claim. Original and corrected cell figures remain scientifically inconsistent as stated. No qualified clinical review.

Endocrine & recovery

Human observational studyAbstract inspected

In a small study of healthy men, long-acting CJC-1295 increased basal and mean GH while preserving the frequency and magnitude of GH pulses. It should not be described as producing wholly non-pulsatile GH secretion.[3]

  • Paired short-term endocrine measurements do not establish body-composition benefits, long-term safety or non-DAC effects.
  • Original full methods were not obtained.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Fresh source inspection of specified original sections; proposed addition awaits independent editorial review.

· Independent editorial worker reopened the cited support; coordinator resolved the requested bibliography corrections and integrated the bounded claim. Original and corrected cell figures remain scientifically inconsistent as stated. No qualified clinical review.

Pharmacokinetics

Human randomized studySupporting passage inspected

In short studies in healthy adults, the long-acting CJC-1295 preparation had estimated half-lives of 5.8–8.1 days after a single subcutaneous dose and prolonged GH and IGF-1 increases. The studies did not specify the DAC salt and do not describe non-DAC CJC-1295 or establish clinical benefit or long-term safety.[2][1]

  • Short healthy-volunteer endocrine studies do not establish long-term efficacy or safety.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Fresh scoped source inspection; locator/date corrections and original full-text evidence recorded. Independent editorial review pending; no qualified clinical review.

· Independent editorial worker reopened the cited support; coordinator resolved the requested bibliography corrections and integrated the bounded claim. Original and corrected cell figures remain scientifically inconsistent as stated. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Restricted the pharmacokinetic finding to the studied long-acting DAC preparation; no non-DAC estimate is inferred.

  • Long-term clinical benefit, safety and combined-secretagogue exposure remain unverified.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

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References

  1. FDA December 2024 compounding briefing: CJC-1295-related bulk substances

    US Food and Drug Administration. 2024-11-15. Regulatory document.

    Inspected location: PDF p. 10/printed p. 6: two active moieties/five BDSs; PDF pp. 32-35/printed pp. 28-31: toxicity and identity qualification; PDF pp. 40-42/printed pp. 36-38: safety/cohort overlap; PDF p. 50/printed p. 46: effectiveness

    Study context and inspection record
  2. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults.

    Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. J Clin Endocrinol Metab. 2006;91(3):799–805. First published online 2005-12-13 (original p. 799). DOI 10.1210/jc.2005-1536. 2005-12-13. PMID:16352683 · DOI:10.1210/jc.2005-1536 Full text inspected.

    Inspected location: Original pp. 799–801 design/Table 1/assay/PK; Original pp. 802-804 endocrine results/safety/discussion/funding

    Study context and inspection record
  3. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog.

    Ionescu M, Frohman LA. J Clin Endocrinol Metab. 2006 Dec;91(12):4792–4797. Published online 2006-10-03. DOI:10.1210/jc.2006-1702. 2006-10-03. PMID:17018654 · DOI:10.1210/jc.2006-1702 Abstract only.

    Inspected location: Europe PMC core: indexed abstract

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-fda-cjc-2024: Identity and active-moiety distinctions, pp. 7–8
  • peptide-pmid-16352683: Abstract: methods, results and estimated half-life

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Related records in this class

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