Investigational — Not FDA-Approved Authoritative Evidence Reference Discontinued Clinical Research

CJC-1295

Synthetic tetrasubstituted growth hormone-releasing hormone (GHRH) 1-29 analogue. Exists in two distinct formulations: CJC-1295 with DAC (Drug Affinity Complex, covalent albumin binder with ~6-8 day half-life) and CJC-1295 without DAC (Mod GRF 1-29, ~30 min half-life). Clinical development by ConjuChem was terminated following a fatal cardiovascular event in a Phase 2 trial. Unapproved by FDA.

Language: English العربية (Arabic) →
Drug Class Growth Hormone-Releasing Hormone (GHRH) Analogue
FDA Regulatory Status Investigational — Not FDA-Approved
Clinical Stage Discontinued Clinical Research
Evidence Verification Active Reference Standards
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60-Second Scientific Briefing

CJC-1295 is an investigational synthetic 29-amino acid GHRH analogue engineered with tetrasubstitutions to resist enzymatic degradation by DPP-IV. CJC-1295 with DAC incorporates a maleimidopropionyl group that conjugates to endogenous serum albumin, extending its half-life to several days. It is NOT FDA-approved and clinical trials were terminated.

What is CJC-1295?

Pharmacological Classification & Molecular Identity

Synthetic 29-amino-acid modified growth hormone-releasing hormone analogue modified to resist dipeptidyl peptidase IV cleavage.

Verified Chemical & Regulatory Registry Identifiers

CAS 863288-34-0 Verified Registry
FDA_UNII 1X7642646S ↗ Verified Registry
PUBCHEM_CID 91971820 ↗ Verified Registry
Documented Aliases & Research Codes:
CJC-1295 DAC CJC-1295 no DAC Mod GRF 1-29 Modified GRF (1-29) Tetrasubstituted GHRH

Mechanism of Action & Receptor Targets

Biological Pathway and Target Binding

Biological pathway and target receptor binding mechanism.

Receptor Selectivity: Activates pituitary GHRH receptors, stimulating sustained growth hormone synthesis and chronic elevation of circulating IGF-1 concentrations.

Regulatory & FDA Approval Status

Legal and Regulatory Classifications
⚠️ STRICT REGULATORY NOTICE: UNAPPROVED INVESTIGATIONAL DRUG

Not approved by the US FDA for any indication. Placed on the FDA 503A Category 2 list due to safety concerns. Prohibited at all times by WADA under Category S2.

CJC-1295 is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.

Human Evidence & Clinical Trials

Clinical Study Readouts and Evidence Syntheses

Evaluated in healthy adults (JCEM 2006) demonstrating prolonged GH/IGF-1 elevation. Clinical development was terminated during Phase 2 trials.

Clinical Evidence

Evaluated in healthy adults (JCEM 2006) demonstrating prolonged GH/IGF-1 elevation. Clinical development was terminated during Phase 2 trials.

Safety Profile & Clinical Limitations

Documented Adverse Events and Known Uncertainties

Injection site pain, headache, diarrhea, flushing, and water retention. Clinical trials were halted due to serious adverse safety events including a patient death in a clinical trial cohort.

ℹ️ Active Research Safety Surveillance

Long-term continuous stimulation of somatotropes and sustained supra-physiological IGF-1 exposure.

Dose Approval Status

Commercial Dosing Status and Policy Directives
🛑 NO APPROVED COMMERCIAL DOSING REGIMEN

NOT ESTABLISHED. No approved human dose exists.

Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.

Storage & Handling Status: NOT ESTABLISHED. Unapproved for commercial human pharmacy distribution.

What is Known vs. What is Unknown

Evidence Comparison and Clinical Evidence Boundaries

✓ Confirmed Scientific Evidence

  • Synthetic 29-amino-acid modified growth hormone-releasing hormone analogue modified to resist dipeptidyl peptidase IV cleavage.
  • Targets & Selectivity: Activates pituitary GHRH receptors, stimulating sustained growth hormone synthesis and chronic elevation of circulating IGF-1 concentrations.
  • Evaluated in healthy adults (JCEM 2006) demonstrating prolonged GH/IGF-1 elevation. Clinical development was terminated during Phase 2 trials.
  • Safety considerations: Injection site pain, headache, diarrhea, flushing, and water retention. Clinical trials were halted due to serious adverse safety events including a patient death in a clinical trial cohort.

? Unknown / Under Ongoing Investigation

  • Long-term continuous stimulation of somatotropes and sustained supra-physiological IGF-1 exposure.

Verified Questions & Answers

10 Verified scientific answers with permanent anchor keys
#1

What is CJC-1295 and how is it classified?

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Direct Answer

CJC-1295 is classified as a Growth Hormone-Releasing Hormone (GHRH) Analogue. Molecular structure: Synthetic 29-amino-acid modified growth hormone-releasing hormone analogue modified to resist dipeptidyl peptidase IV cleavage..

Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.

#2

What is the mechanism of action and receptor profile of CJC-1295?

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Direct Answer

CJC-1295 exerts biological activity via Activates pituitary GHRH receptors, stimulating sustained growth hormone synthesis and chronic elevation of circulating IGF-1 concentrations..

Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.

#3

Is CJC-1295 approved by the US FDA or health authorities?

§
Direct Answer

Regulatory status: Not approved by the US FDA for any indication. Placed on the FDA 503A Category 2 list due to safety concerns. Prohibited at all times by WADA under Category S2.

Investigational and research-only compounds cannot be legally distributed or marketed as prescription drugs.

#4

What human clinical evidence and trials exist for CJC-1295?

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Direct Answer

Clinical evaluation status: Evaluated in healthy adults (JCEM 2006) demonstrating prolonged GH/IGF-1 elevation. Clinical development was terminated during Phase 2 trials.

Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.

#5

What adverse effects and safety risks are documented for CJC-1295?

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Direct Answer

Reported safety profile: Injection site pain, headache, diarrhea, flushing, and water retention. Clinical trials were halted due to serious adverse safety events including a patient death in a clinical trial cohort.

Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.

Authoritative Citations:
#6

What are the critical unknown safety aspects and clinical limitations of CJC-1295?

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Direct Answer

Key scientific uncertainties: Long-term continuous stimulation of somatotropes and sustained supra-physiological IGF-1 exposure.

Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.

Authoritative Citations:
#7

What is the approved dosing status for CJC-1295?

§
Direct Answer

NOT ESTABLISHED. No approved human dose exists.

Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.

Authoritative Citations:
#8

What are the storage and handling requirements for CJC-1295?

§
Direct Answer

Storage status: NOT ESTABLISHED. Unapproved for commercial human pharmacy distribution.

Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.

Authoritative Citations:
#9

Is CJC-1295 prohibited in competitive sports by WADA?

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Direct Answer

Yes. Unapproved pharmacological substances are strictly prohibited at all times in competitive sports under WADA Category S0 (Non-approved substances) or Category S2.

Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.

#10

What is Egypt Peptides' official medical policy regarding CJC-1295?

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Direct Answer

Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.

All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.

Authoritative Sources & Literature Registry

Regulatory dossiers, clinical trial registries, and peer-reviewed studies
Source [1] Tier 1 Regulatory / Academic

World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) ↗

Publisher / Registry: World Anti-Doping Agency Publication Date: 2024-01-01
Verified Locator: https://www.wada-ama.org/en/prohibited-list
Source [2] Tier 1 Regulatory / Academic

FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) ↗

Publisher / Registry: U.S. Food and Drug Administration Publication Date: 2023-09-29
Verified Locator: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Source [3] Tier 2 Regulatory / Academic

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 ↗

Publisher / Registry: The Journal of Clinical Endocrinology & Metabolism Publication Date: 2006-03-01 PubMed PMID: 16352683 DOI: 10.1210/jc.2005-1536
Verified Locator: https://doi.org/10.1210/jc.2005-1536

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