CJC-1295: Safety Profile & Research Summary
Key Clinical Studies
| Study | Design | Key Outcome |
|---|---|---|
| Teichman et al. (2006) — J Clin Endocrinol Metab | Phase I, RCT, 64 healthy adults | Single SC dose: GH ↑ 1.5–3× baseline; IGF-1 ↑ 1.3–1.9× for 9–11 days; well-tolerated |
| Ionescu & Frohman (2006) — J Clin Endocrinol Metab | Phase II feasibility, adults with GHD | Dose-dependent GH/IGF-1 elevation; confirmed durability of tonic GH elevation |
| Jette et al. (2005) — Endocrinology | Preclinical/early PK | Established DAC albumin-binding kinetics; confirmed covalent albumin-Cys34 bond |
| Alba et al. (2006) — Am J Physiol Endocrinol Metab | Preclinical (hypophysectomized rats) | Growth normalization at 50–100 µg/kg doses; established dosing rationale |
| Ben-Shlomo et al. (2020) — Neuroendocrinology | Preclinical (in vitro somatotrophs) | Hypothesis: tonic GHRH stimulation may cause somatotroph DNA damage; mechanistic concern |
Research Dosing Reference (Phase I Data Only)
| Parameter | Phase I Data (Teichman 2006) |
|---|---|
| Doses tested | 30–60 µg/kg SC single injection |
| GH response duration | 9–11 days after single dose |
| IGF-1 increase | 1.3 to 1.9-fold above baseline |
| Administration route | Subcutaneous injection |
| Tolerability | Generally well-tolerated; mild injection site reactions; transient flushing |
Safety Profile (Phase I Data)
| Observation | Detail |
|---|---|
| Most common adverse effects | Injection site reactions, transient facial flushing, headache, dizziness |
| Serious adverse events | None dose-limiting in Phase I |
| Pulsatility | Maintained normal pulsatile GH secretion superimposed on tonic elevation |
| Feedback axis | Negative feedback (somatostatin, IGF-1) remained functional |
| Regulatory note | FDA Category 2 (Dec 2024); not approved for human therapeutic use; WADA S2 prohibited |
In Vitro / Preclinical Disclaimer: The findings described above are based on in vitro laboratory studies and preclinical animal research. Results obtained in cell culture or animal models may not translate to human outcomes. This information is provided solely for scientific and educational reference regarding ongoing research into this compound.
Educational Use Only: All information on this page is intended for educational and research reference purposes only. CJC-1295 is not approved by the FDA or any regulatory agency for human therapeutic use. This content does not constitute medical advice, and the compound described is sold strictly for laboratory research use in accordance with applicable law.
References
- Jetté L, et al. (2005). 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, 146(7):3052–3058.
- Ionescu M, Frohman LA. (2006). Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab, 91(12):4792–4797.
- Teichman SL, et al. (2006). 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, 91(3):799–805.
- Alba M, et al. (2006). Once-monthly administration of CJC-1295, a long-acting growth hormone-releasing hormone (GHRH) analog, normalizes growth in the GHRH-deficient dwarf rat. Am J Physiol Endocrinol Metab, 291(6):E1290–E1294.
- Walker RF. (2006). Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging, 1(4):307–308.
- Ben-Shlomo A, et al. (2020). Growth hormone-releasing hormone (GHRH) and its analogues: from bench to bedside. Neuroendocrinology, 110(3–4):192–199.
- Gahete MD, et al. (2009). In vivo and in vitro evidence for the importance of growth hormone-releasing hormone in the regulation of GH secretion. Mol Cell Endocrinol, 309(1–2):40–47.
- FDA. (2024). Bulk Drug Substances Under Evaluation for Use in Compounding Under Section 503A: Category 2. Docket FDA-2013-N-1525. Federal Register, Dec 2024.
- WADA. (2024). List of Prohibited Substances and Methods. S2: Peptide Hormones, Growth Factors, Related Substances, and Mimetics. World Anti-Doping Agency.
- Frohman LA, Jansson JO. (1986). Growth hormone-releasing hormone. Endocr Rev, 7(3):223–253.
Related Research Questions
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This content is provided for educational and informational purposes only. Products are furnished for in-vitro studies only and are not medicines, drugs, or supplements. Not approved by the FDA to prevent, treat, or cure any condition.