CJC-1295

Peptide Data Sheet for Pharmacists and Compounding Professionals

BASIC INFORMATION

Name: CJC-1295
Class: Growth hormone releasing hormone (GHRH) analog
Structure: Modified 30-amino acid peptide analog of GHRH
Molecular Weight: 3368 g/mol
Chemical Modifications:

  • Addition of Drug Affinity Complex (DAC)
  • Substitution of four amino acids to prevent enzymatic degradation
  • Lysine at position 30 allows for conjugation with biotin, albumin, or other proteins

Available Forms:

  • Research peptide
  • Compounded formulations (subject to regulatory requirements)
  • Not available as an FDA-approved medication
  • Often found in two variants:
    • CJC-1295 with DAC (longer half-life)
    • CJC-1295 without DAC (sometimes called “Modified GRF 1-29”)

REGULATORY STATUS

FDA Status

  • Not FDA-approved for any medical condition
  • Classified as a research compound
  • FDA has clarified it is among peptides unlawful to use in making compounded medications
  • Included on FDA’s list of substances nominated for the 503B bulks list that raised significant safety concerns

Legal Considerations

  • Not approved for human use or consumption
  • Often marketed “for research purposes only”
  • Compounding pharmacies should be aware that FDA has specifically identified CJC-1295 as a substance that should not be used in compounding

MECHANISM OF ACTION

CJC-1295 is a synthetic analog of growth hormone-releasing hormone (GHRH) that:

  • Binds to GHRH receptors in the anterior pituitary gland
  • Stimulates the pulsatile release of growth hormone (GH)
  • Increases insulin-like growth factor 1 (IGF-1) production
  • With DAC modification, forms covalent bonds with serum albumin, extending its half-life
  • Mimics the action of endogenous GHRH but with greater stability and duration

The DAC technology (Drug Affinity Complex) enables:

  • Protection from enzymatic degradation
  • Reduced renal clearance
  • Extended half-life from minutes to days
Mechanism of Action

PHARMACOKINETICS

| Parameter | Value | Notes | |———–|——-|——-| | Absorption | Rapid after subcutaneous injection | Complete bioavailability | | Distribution | Widely distributed | Binds to albumin (with DAC) | | Metabolism | Resistant to enzymatic degradation | Modified amino acids prevent breakdown | | Elimination | Half-life: <30 minutes (without DAC)<br>6-8 days (with DAC) | DAC significantly extends half-life |

Note: Pharmacokinetic data is primarily derived from limited human studies and animal research.

POTENTIAL APPLICATIONS (INVESTIGATIONAL)

Note: All applications are investigational and not FDA-approved. This information is provided for educational purposes only.

Endocrine

  • Growth hormone deficiency (investigational)
  • Age-related decline in growth hormone

Metabolic

  • Body composition improvement
  • Lipid metabolism
  • Insulin sensitivity

Other Investigational Areas

  • Recovery from injury
  • Sleep quality improvement
  • Immune system modulation

ADMINISTRATION (INVESTIGATIONAL)

Routes

  • Subcutaneous injection (most common)
  • Intramuscular injection (less common)

Investigational Dosing

Note: No established safe or effective dosing regimen exists. The following information is based on research protocols and is not a recommendation for clinical use.

| Variant | Investigational Dose Range | Frequency | |———|—————————-|———–| | CJC-1295 with DAC | 1-2 mg | Once weekly | | CJC-1295 without DAC | 100-200 mcg | Daily or multiple times weekly |

SAFETY PROFILE

Reported Adverse Effects

Note: Safety data is limited and primarily from small studies and anecdotal reports.

  • Injection site reactions (redness, pain, swelling)
  • Headache
  • Flushing
  • Water retention
  • Numbness or tingling in extremities
  • Joint pain
  • Increased insulin resistance
  • Fatigue

Potential Risks and Concerns

  • Potential for growth promotion in pre-existing cancers
  • Glucose metabolism alterations
  • Fluid retention
  • Carpal tunnel syndrome
  • Gynecomastia
  • Acromegalic effects with long-term use
  • Unknown long-term effects
  • Lack of quality control in commercially available products

Contraindications (Theoretical)

  • Active malignancy
  • History of pituitary disorders
  • Uncontrolled diabetes
  • Pregnancy and lactation
  • Children and adolescents
  • Intracranial hypertension

SPECIAL POPULATIONS

Pregnancy and Lactation

  • No human data available
  • Avoid use due to unknown risks

Pediatric

  • No human data available
  • Not recommended for use in pediatric populations
  • Theoretical risk of affecting growth plates and development

Geriatric

  • No specific data available
  • Potentially higher risk of adverse effects
  • May have different response due to age-related changes in GH/IGF-1 axis

PHARMACIST GUIDANCE

Compounding Considerations

  • FDA has clarified that CJC-1295 is among peptides unlawful to use in making compounded medications
  • Pharmacists should be aware of regulatory restrictions
  • If compounding is legally permitted in specific circumstances:
    • Requires aseptic technique and sterile compounding environment
    • Stability affected by temperature and mechanical agitation
    • Adhere to USP <797> standards for sterile compounding

Storage and Handling (Research Settings)

  • Store lyophilized peptide at -20°C
  • Reconstituted solutions typically stored at 2-8°C
  • Use within 30 days of reconstitution
  • Avoid repeated freeze-thaw cycles
  • Protect from light

Patient Counseling Points

  • Not FDA-approved for any indication
  • Limited safety and efficacy data in humans
  • Unknown long-term effects
  • Potential for serious adverse effects
  • Importance of discussing all supplements and medications with healthcare providers
  • FDA has warned against its use in compounded medications

ETHICAL AND PROFESSIONAL CONSIDERATIONS

For Pharmacists

  • Be aware of FDA position on CJC-1295 in compounding
  • Understand legal and ethical implications of dispensing non-FDA approved peptides
  • Maintain professional standards when discussing investigational compounds
  • Provide evidence-based information when consulted about CJC-1295
  • Consider liability issues related to non-FDA approved compounds

For Researchers

  • Ensure proper informed consent in research settings
  • Follow institutional and regulatory guidelines for research peptides
  • Document and report adverse events
  • Maintain scientific integrity in research protocols

REFERENCES

  1. FDA. Certain Bulk Drug Substances for Use in Compounding May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  2. Teichman SL, et al. 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. J Clin Endocrinol Metab. 2006;91(3):799-805.
  3. Alba M, et al. Once-daily administration of CJC-1295, a long-acting growth hormone-releasing hormone (GHRH) analog, normalizes growth in the GHRH knockout mouse. Am J Physiol Endocrinol Metab. 2006;291(6):E1290-300.
  4. Jetté L, et al. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology. 2005;146(7):3052-8.
  5. FDA. Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. https://www.fda.gov/media/94393/download