CJC-1295 with Ipamorelin: Not FDA-Approved and Lacks Clinical Guidelines
CJC-1295 with Ipamorelin is not FDA-approved for any medical indication, and there are no established clinical guidelines supporting its use. This combination is not recommended for clinical use due to lack of safety and efficacy data from high-quality clinical trials.
Mechanism of Action
- CJC-1295 is a synthetic peptide analog of Growth Hormone-Releasing Hormone (GHRH) that stimulates the pituitary gland to produce growth hormone (GH) 1
- CJC-1295 has a prolonged half-life (5.8-8.1 days) compared to natural GHRH due to its ability to covalently bind to plasma proteins like albumin 1, 2
- Ipamorelin is a synthetic pentapeptide that functions as a Growth Hormone Secretagogue (GHS), stimulating GH release through a different pathway 3
- The combination is theoretically designed to synergistically increase GH production through complementary mechanisms 4
Research Evidence
- CJC-1295 alone has shown dose-dependent increases in GH (2-10 fold) for 6+ days and IGF-1 (1.5-3 fold) for 9-11 days in limited human studies 1
- Daily administration of CJC-1295 normalized growth in GHRH-knockout mice, but less frequent dosing (every 48-72 hours) was less effective 5
- Ipamorelin demonstrated dose-dependent increases in longitudinal bone growth rate and body weight in rat studies 3
- No high-quality human clinical trials have evaluated the safety and efficacy of the CJC-1295/Ipamorelin combination 6, 2
Safety Concerns
- The long-term safety profile of these peptides in humans is unknown 1
- Potential side effects based on the mechanism may include:
- Glucose metabolism alterations and potential insulin resistance 4
- Fluid retention and joint pain
- Potential impact on existing tumors due to IGF-1 stimulation
- Unknown drug interactions
Regulatory Status
- CJC-1295 and Ipamorelin are not FDA-approved medications 6, 2
- These compounds are sometimes illicitly manufactured and distributed 2
- The World Anti-Doping Agency (WADA) considers these substances prohibited as they fall under Section S2 (peptide hormones and growth factors) 2
Clinical Implications
- There are established FDA-approved treatments for growth hormone deficiency that should be used instead of unapproved peptides 7
- For children with growth disorders, recombinant human growth hormone (rhGH) at 28 IU/m²/week (or 0.05 mg/kg/day) is the recommended treatment 7
- Growth hormone therapy should only be initiated after proper diagnostic evaluation by qualified specialists 7
Conclusion
The use of CJC-1295 with Ipamorelin lacks sufficient evidence for safety and efficacy. Patients seeking treatment for growth hormone-related conditions should be directed to FDA-approved therapies administered under appropriate medical supervision.