CJC-1295 No Dac: Safety Profile & Research Summary

Research Summary

Clinical & Preclinical Data Status

According to a comprehensive FDA evaluation prepared for the Pharmacy Compounding Advisory Committee (December 2024), there are no published human clinical trials and no preclinical efficacy or toxicity studies specifically for CJC-1295 without DAC (Modified GRF 1-29). All prominent clinical trials associated with the name "CJC-1295" in medical literature were conducted using the DAC variant, which is pharmacokinetically distinct due to its albumin-binding Drug Affinity Complex.[9][10]

Key Studies on CJC-1295 (DAC Variant) — Often Misattributed to No-DAC

Study	Model	Key Findings	Ref
Teichman et al. (2006) J Clin Endocrinol Metab	Healthy human adults; 30–250 mcg/kg SC; single or weekly/biweekly doses	Dose-dependent increases in mean plasma GH (2–10-fold for ≥6 days) and IGF-1 (1.5–3-fold for 9–11 days). Half-life 5.8–8.1 days. Note: DAC variant, not applicable to no-DAC.	[8]
Ionescu & Frohman (2006) J Clin Endocrinol Metab	Healthy human adults; CJC-1295 with DAC	Confirmed that pulsatile GH secretion persists during continuous stimulation by CJC-1295 (DAC). Note: DAC variant.	[15]
Jetté et al. (2005) Endocrinology	Sprague-Dawley rats; 1 µmol/kg SC	Described synthesis of tetrasubstituted GHRH core and DAC conjugation. Demonstrated GH elevation with half-life >72 hours. Note: DAC variant.	[4]
Alba et al. (2006) Am J Physiol	GHRH knockout mice; 2 µg/mouse daily	Normalized growth; increased body length and lean mass; increased pituitary GH mRNA and somatotroph proliferation. Note: DAC variant.	[8]
Ben-Shlomo et al. (2020) J Clin Invest	C57BL/6 mice and primary pituitary cultures; 10–50 ng/mL in vitro	Intense cAMP stimulation induced DNA damage in somatotrophs (H2AX phosphorylation, comet assays). Increased GH levels and pituitary weight in vivo. Note: Likely DAC variant per FDA assessment.	[14]

Studies Specific to CJC-1295 No DAC (Analytical/Forensic Only)

Study	Context	Key Findings	Ref
Henninge et al. (2010) Drug Test Anal	Norwegian Doping Control Laboratory; seized pharmaceutical preparations	Identified Modified GRF 1-29 (CJC-1295 without DAC) in seized products using mass spectrometry. Confirmed widespread distribution of no-DAC variant mislabeled as CJC-1295.	[1]
Hartvig et al. (2014) Scand J Forensic Sci	Danish authorities; doping compounds confiscated 2007–2013	Identified CJC-1295 (no DAC) among confiscated peptide preparations. No therapeutic efficacy or safety data generated.	[3]
Fabresse et al. (2017) Toxicol Anal Clin	LC-HRMS/MS identification of CJC-1295 analogs	Developed high-resolution mass spectrometric methods for identifying CJC-1295 peptide analogs in analytical chemistry settings.	[13]

FDA Assessment Summary (December 2024)

Category	FDA Finding for CJC-1295 No DAC
Clinical Trials	None identified. No Phase I, II, or III trials for CJC-1295 (free base) or CJC-1295 acetate.[9]
Preclinical Pharmacology	None identified. No nonclinical pharmacological studies for this specific substance.[9]
Preclinical Toxicity	None identified. No acute toxicity, repeat-dose toxicity, genotoxicity, developmental/reproductive toxicity, or carcinogenicity studies.[9]
Safety Profile	Unknown in humans. Potential risks include immunogenicity and injection site reactions based on peptide characteristics.[9]
Regulatory Classification	Category 2. Significant safety risks or insufficient evidence; restricted from pharmacy compounding.[9][10]

Dosage Overview (From Literature & Clinical Practice)

Setting	Dose	Route / Schedule	Notes
In Vitro (pituitary cultures)	10–50 ng/mL	Cell culture	Ben-Shlomo et al. (2020); likely DAC variant[14]
Animal (rats — DAC variant)	1 µmol/kg SC	Subcutaneous injection	Jetté et al. (2005)[4]
Animal (mice — DAC variant)	2 µg/mouse daily	Subcutaneous injection	Alba et al. (2006)[8]
Human (DAC variant)	30–250 mcg/kg	SC; single or weekly/biweekly	Teichman et al. (2006)[8]
Human (no-DAC; clinical practice)	100–300 mcg	SC; 1–3x daily or 5 days/week	Anecdotal protocols; not derived from clinical trials

Safety Considerations

Parameter	Finding
Clinical Safety Data	No submitted or identified clinical safety studies for CJC-1295 (free base) or acetate[9]
Preclinical Toxicity Data	No nonclinical toxicity studies (acute, repeat-dose, genotoxicity) identified[9]
Immunogenicity	Theoretical risk of antibody formation; 86% homology with endogenous GHRH[9]
Reported Adverse Effects (Anecdotal)	Injection site reactions, flushing, headache, transient hypotension, water retention[12]
Contraindications (General GHRH Analog)	Active malignancy (GH/IGF-1 may promote tumor growth), pregnancy/breastfeeding, hypersensitivity[7]
DAC Variant Safety Note	CJC-1295 with DAC was discontinued during Phase 2 trials after a patient death (attributed to underlying coronary artery disease, not the drug); no such event linked to the no-DAC variant[7]