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 administration; GH, IGF-1 and tolerability endpoints |
| 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 in rodents |
| Ben-Shlomo et al. (2020) — J Clin Invest | Preclinical (in vitro somatotrophs) | Hypothesis: tonic GHRH stimulation may cause somatotroph DNA damage; mechanistic concern |
Safety Profile (Phase I Data)
| Observation | Detail |
|---|---|
| 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.
“(2005) — EndocrinologyPreclinical/early PKEstablished DAC albumin-binding kinetics; confirmed covalent albumin-Cys34 bond Alba et al.”
References
- Jetté L, et al. (2005). 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). J Clin Endocrinol Metab, 91(3):799–805.
- Alba M, et al. (2006). Am J Physiol Endocrinol Metab, 291(6):E1290–E1294.
- Walker RF. (2006). Clin Interv Aging, 1(4):307–308.
- Ben-Shlomo A, Deng N, Ding E, et al. (2020). DNA damage and growth hormone hypersecretion in pituitary somatotroph adenomas. J Clin Invest, 130(11):5738–5755.
- 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.
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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.