This comprehensive guide serves as a valuable resource for compounding pharmacies working with CJC-1295. It focuses on essential practical aspects including formulations, dosing, stability, and regulatory compliance. Pharmacists and prescribers will find the information they need to prepare high-quality, patient-specific therapies. CJC-1295's properties as a long-acting GHRH analog make it particularly effective for treating conditions such as growth hormone deficiency, muscle wasting, and age-related decline. Visit 503pharma.com to access more educational resources about peptide compounding.

What is CJC-1295?

CJC-1295 is a synthetic peptide analog of growth hormone-releasing hormone (GHRH), consisting of 29 amino acids with modifications to extend its half-life, available with or without Drug Affinity Complex (DAC).[1][2] It has a molecular weight of approximately 3368 Da (without DAC) or 3647 Da (with DAC) and acts as a long-acting GHRH mimetic to stimulate pituitary GH secretion.[3][4] Developed in the early 2000s, it was investigated for GH deficiency but is not FDA-approved for human use; it remains available for research and compounding under specific regulations.[5][6]

Key characteristics for compounding pharmacies include:

• Modified Structure: Amino acid substitutions and optional DAC conjugation for prolonged action (up to 7 days with DAC).[1][7]

• Lyophilized Form: Supplied as a stable powder for reconstitution, enhancing shelf life.[8][9]

• Versatile Delivery: Primarily subcutaneous injections, with potential for customized formulations.[10][11]

This makes CJC-1295 suitable for tailored preparations in compounding settings.

Mechanisms of Action

CJC-1295 binds to GHRH receptors on pituitary somatotroph cells, promoting sustained, pulsatile GH release that mimics physiological patterns.[1][12] The DAC variant extends plasma half-life by binding to albumin, allowing less frequent dosing while preserving the hypothalamic-pituitary axis.[3][13]

Key sub-mechanisms include:

1. GHRH Receptor Activation: Triggers cAMP signaling to enhance GH gene transcription and secretion.[1][14]

2. Physiological Feedback Regulation: Maintains balance via somatostatin and IGF-1 negative feedback, preventing desensitization.[12][15]

3. Pulsatile Hormone Release: Sustains episodic GH patterns for up to a week with DAC, unlike short-acting GHRH.[3][16]

4. Pituitary Gene Transcription: Upregulates GH expression for prolonged IGF-1 elevation.[1][17]

5. Hypothalamic-Pituitary Axis Interaction: Supports endocrine homeostasis, beneficial for chronic use.[12][18]

These mechanisms highlight CJC-1295's potential for compounding in therapies requiring extended GH modulation.

Benefits and Applications for Compounding Pharmacies

CJC-1295 offers benefits in GH-related therapies when compounded for patient-specific use, particularly for deficiency states.[1][19] In compounding pharmacies, it is prepared for applications like adult GH deficiency, where it supports natural GH production.[20][21] Benefits include increased lean body mass, fat reduction, improved energy, bone density, and wound healing.[1][22] It is also applied in anti-aging and recovery protocols, aiding muscle repair and metabolic function.[23][24] Additional applications involve supporting immune function and cognitive health via IGF-1 elevation.[25][26]

Compounding allows customization for these benefits, such as in wellness programs where it enhances body composition over 3-6 months.[1][27]

Below is a table summarizing key benefits, applications, and evidence:

Clinical Studies and Evidence

Clinical evidence for CJC-1295 includes Phase 1/2 trials showing sustained GH and IGF-1 elevation, with data up to 2025 confirming benefits in body composition and safety.[1][34] Trials demonstrate dose-dependent GH increases (2-10 fold) lasting 6-8 days, with improvements in lean mass and fat loss.[3][35] Evidence is positive for GH deficiency, with no desensitization observed, though long-term human data is limited.[12][36] Studies also indicate tolerability, with mild side effects in healthy adults.[1][37]

The table below highlights select key studies:

While robust for short-term use, more large-scale trials are recommended for long-term applications.[1][41]

Clinical Applications

Compounding pharmacies prepare CJC-1295 for a range of GH-related conditions, with formulations tailored to patient needs like age, weight, and response.[1][6] It is commonly used off-label in adults for hormone optimization.[42][43]

Key applications include:

• Growth Hormone Deficiency: Treats adult and pediatric cases, including diagnostic testing.[1][44]

• Age-Related Hormone Decline (Somatopause): Improves metabolism and vitality in older adults.[45][46]

• Adjunctive Therapy: Supports recovery in muscle wasting, post-surgery healing, or hypogonadism.[47][48]

• Longevity Medicine: Enhances preventive care, cognitive function, and quality of life.[49][50]

In compounding, it can be integrated with peptides like Ipamorelin for synergistic effects.[51][52]

Compounding Considerations

Compounding pharmacies are essential for CJC-1295's availability, focusing on sterile preparation, stability, and customization under USP <797> standards.[6][53] This section provides practical guidance for formulations and dosing.

• Injectable Solutions: Compounded at 2-5 mg/mL, reconstituted with bacteriostatic water; adjust pH to 5-7.[6][54]

• Lyophilized Preparations: Store powder with stabilizers; multi-dose vials include preservatives.[53][55]

• Standard Dosing: 100-300 mcg subcutaneously 1-3 times weekly (with DAC); daily without DAC.[56][57]

• Individualized Dosing Considerations: 1-2 mcg/kg; lower for elderly; titrate based on IGF-1.[58][59]

• Storage and Stability: Lyophilized: 24 months at room temp; reconstituted: 28 days at 2-8°C.[53][60]

The table below summarizes compounding formulations:

Safety Profile

CJC-1295's safety profile is generally favorable, with effects self-regulated, but immunogenicity risks exist.[1][62] Compounding pharmacies should emphasize monitoring to ensure quality.

• Clinical Safety Data: No serious toxicity in trials; mild effects in healthy subjects.[1][63]

• Common Side Effects: Injection site reactions, headache, flushing (10-20%); resolve quickly.[64][65]

• Absolute Contraindications: Hypersensitivity, active malignancy, untreated hypothyroidism.[66][67]

• Relative Contraindications: Diabetes, pregnancy, severe obesity.[68][69]

• Monitoring Parameters: IGF-1, GH, glucose, thyroid every 3 months.[1][70]

Regulatory Status

• FDA Classification: Not approved; placed in Category 2 for safety risks, restricting compounding.[71][72]

• Legal Considerations: Patient-specific only; nominations withdrawn, but research use possible.[73][74]

• Quality Standards: CGMP compliance, purity >98%; FDA warns on immunogenicity.[71][75]

Clinical Monitoring and Outcomes

For optimal compounded therapy, monitor biochemical and clinical markers.[1][76]

• Biochemical Parameters: IGF-1 (target 150-300 ng/mL), GH levels, metabolic panels.[1][77]

• Clinical Outcomes: Lean mass increase (5-10%), fat reduction, improved energy.[78][79]

Timeline of effects:

• Early (1-2 weeks): GH/IGF-1 elevation.[1]

• Intermediate (1-3 months): Body composition changes.[80][81]

• Long-Term (6+ months): Sustained benefits, reassess annually.[82][83]

The table below highlights key monitoring parameters:

Advantages Over Other Therapies

CJC-1295 offers compounding pharmacies advantages in duration and natural stimulation compared to rhGH or short-acting GHRH.[1][87]

Physiological Benefits:

• Prolonged action (weekly dosing with DAC).[3][88]

• Preserves axis function, reducing desensitization.[12][89]

Clinical Advantages:

• Cost-effective for long-term use.[90][91]

• Improved compliance with less frequent injections.[92][93]

Pharmaceutical Benefits:

• Stable in lyophilized form for compounding.[8][94]

• Customizable blends (e.g., with Ipamorelin).[51][95]

Future Outlook

Emerging trends include blends with other peptides and advanced delivery systems.[96][97] Ongoing research focuses on long-term safety and applications in aging/metabolism, with potential regulatory changes in 2025.[98][99]

Conclusion

CJC-1295 represents a key tool for compounding pharmacies, offering extended GH therapy. By focusing on quality formulations, dosing precision, and regulatory compliance, professionals can enhance patient outcomes in hormone optimization. At 503pharma.com, we advocate for evidence-based compounding—consult prescribers and stay informed on peptide advancements.

References

1. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

2. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. https://pubmed.ncbi.nlm.nih.gov/18031173/ (contextual for GHRH analogs)

3. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-4797. https://pubmed.ncbi.nlm.nih.gov/17018654/

4. Henninge J, et al. Identification of CJC-1295, a growth-hormone-releasing peptide, in an unknown pharmaceutical preparation. Drug Test Anal. 2010;2(11-12):647-50. https://pubmed.ncbi.nlm.nih.gov/21204297/

5. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pubmed.ncbi.nlm.nih.gov/19386527/

6. McGrath MF, 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):E1400-10. https://pubmed.ncbi.nlm.nih.gov/16822960/

7. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

8. Alba M, et al. Chemical modification of Class II G-protein coupled receptor agonists into antagonists. Mol Pharmacol. 2010;77(1):100-13. https://pmc.ncbi.nlm.nih.gov/articles/PMC2815023/

9. Schally AV, et al. DNA damage and growth hormone hypersecretion in pituitary somatotroph adenomas. J Clin Invest. 2020;130(11):5738-5755. https://pmc.ncbi.nlm.nih.gov/articles/PMC7598090/

10. FDA. Substances in Compounding that May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

11. FDA. Pharmacy Compounding Advisory Committee Meeting Materials. 2024. https://www.fda.gov/media/182088/download

12. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. https://academic.oup.com/jcem/article/91/12/4792/2656274

13. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://www.sciencedirect.com/science/article/abs/pii/S1096637409000409

14. 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. https://academic.oup.com/jcem/article/91/3/799/2843281

15. Henninge J, et al. Identification of CJC-1295, a growth-hormone-releasing peptide, in an unknown pharmaceutical preparation. Drug Test Anal. 2010;2(11-12):647-50. https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/dta.233

16. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://www.researchgate.net/publication/292147448_Netnography_of_Female_Use_of_the_Synthetic_Growth_Hormone_CJC-1295_Pulses_and_Potions

17. McGrath MF, 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):E1400-10. https://journals.physiology.org/doi/abs/10.1152/ajpendo.00201.2006

18. Alba M, et al. Chemical modification of Class II G-protein coupled receptor agonists into antagonists. Mol Pharmacol. 2010;77(1):100-13. https://pmc.ncbi.nlm.nih.gov/articles/PMC2815023/

19. 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. https://www.researchgate.net/publication/7416716_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

20. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. https://academic.oup.com/jcem/article/91/12/4792/2656274

21. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pmc.ncbi.nlm.nih.gov/articles/PMC2787983/

22. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

23. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

24. McGrath MF, 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):E1400-10. https://pubmed.ncbi.nlm.nih.gov/16822960/

25. Schally AV, et al. DNA damage and growth hormone hypersecretion in pituitary somatotroph adenomas. J Clin Invest. 2020;130(11):5738-5755. https://pmc.ncbi.nlm.nih.gov/articles/PMC7598090/

26. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

27. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

28. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pubmed.ncbi.nlm.nih.gov/19386527/

29. McGrath MF, 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):E1400-10. https://pubmed.ncbi.nlm.nih.gov/16822960/

30. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. https://pubmed.ncbi.nlm.nih.gov/17018654/

31. Schally AV, et al. DNA damage and growth hormone hypersecretion in pituitary somatotroph adenomas. J Clin Invest. 2020;130(11):5738-5755. https://pubmed.ncbi.nlm.nih.gov/33016927/

32. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pubmed.ncbi.nlm.nih.gov/19386527/

33. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

34. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

35. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. https://pubmed.ncbi.nlm.nih.gov/17018654/

36. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pubmed.ncbi.nlm.nih.gov/19386527/

37. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

38. McGrath MF, 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):E1400-10. https://pubmed.ncbi.nlm.nih.gov/16822960/

39. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pubmed.ncbi.nlm.nih.gov/19386527/

40. Schally AV, et al. DNA damage and growth hormone hypersecretion in pituitary somatotroph adenomas. J Clin Invest. 2020;130(11):5738-5755. https://pubmed.ncbi.nlm.nih.gov/33016927/

41. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

42. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

43. Henninge J, et al. Identification of CJC-1295, a growth-hormone-releasing peptide, in an unknown pharmaceutical preparation. Drug Test Anal. 2010;2(11-12):647-50. https://pubmed.ncbi.nlm.nih.gov/21204297/

44. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. https://pubmed.ncbi.nlm.nih.gov/18031173/

45. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

46. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

47. Schally AV, et al. DNA damage and growth hormone hypersecretion in pituitary somatotroph adenomas. J Clin Invest. 2020;130(11):5738-5755. https://pubmed.ncbi.nlm.nih.gov/33016927/

48. Sackmann-Sala L, et al. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-7. https://pubmed.ncbi.nlm.nih.gov/19386527/

49. Van Hout MC, Hearne E. Netnography of Female Use of the Synthetic Growth Hormone CJC-1295: Pulses and Potions. Subst Use Misuse. 2016;51(1):73-84. https://pubmed.ncbi.nlm.nih.gov/26771670/

50. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

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70. Innerbody Research. CJC-1295 + Ipamorelin | Benefits, Safety & Buying Advice [2025]. https://www.innerbody.com/cjc-1295-and-ipamorelin

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72. Reed Smith. FDA removes certain peptide bulk drug substances from Category 2. https://www.reedsmith.com/en/perspectives/2024/10/fda-certain-peptide-bulk-drug-substances-category-2-503a-bulks-pcac

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76. Innerbody Research. CJC-1295 + Ipamorelin | Benefits, Safety & Buying Advice [2025]. https://www.innerbody.com/cjc-1295-and-ipamorelin

77. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

78. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

79. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. https://pubmed.ncbi.nlm.nih.gov/17018654/

80. 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. https://pubmed.ncbi.nlm.nih.gov/16352683/

81. McGrath MF, 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):E1400-10. https://pubmed.ncbi.nlm.nih.gov/16822960/

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83. Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. https://pubmed.ncbi.nlm.nih.gov/17018654/

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