# CJC-1295 Side Effects in the Research Literature

> CJC-1295 side effects as reported in published phase-1 trials: injection-site reactions, facial flushing, headache, mild nausea. Plus what the regulatory record adds.

*What phase-1 trials of CJC-1295 reported. What the FDA flagged. What the literature does not establish.*

## CJC-1295 side effects reported in published studies

The phase-1 single-ascending-dose and multi-dose trials of CJC-1295 with DAC in healthy adults reported transient injection-site reactions, facial flushing, headache, and mild nausea among the more common acute effects, with no serious adverse events at the doses studied (30 to 250 µg/kg single dose; 60 µg/kg weekly or every other week multi-dose) [1][16]. The FDA's 2024 briefing document for the Pharmacy Compounding Advisory Committee separately reviewed the available CJC-1295 safety record and discussed peptide aggregation, immunogenicity, and adverse events including cardiovascular signals associated with the DAC variant [13]. Long-term human safety data does not exist in peer-reviewed literature; the longest published dosing window in healthy adults is the 49-day Teichman multi-dose arm [16].

## Why CJC-1295 can cause flushing

Transient facial flushing was reported as one of the more common acute effects in the Teichman 2006 phase-1 trial of CJC-1295 with DAC [1]. The mechanism is consistent with the vasodilatory action that accompanies pulsatile growth-hormone release — GHRH-receptor agonism produces a brief vasoreactive response in addition to the somatotroph-stimulating effect [1]. Flushing in the reported phase-1 cohort was self-limiting and did not require intervention at the doses tested.

## CJC-1295 and hair: what the literature does and does not show

Hair loss is not reported as an effect in the published phase-1 trials of CJC-1295 with DAC [1][16]. Anecdotal user reports exist on consumer forums but are outside the peer-reviewed evidence base. This is an absence-of-reported-evidence statement rather than a safety clearance: the indexed phase-1 record did not measure or describe hair-related endpoints, so the literature establishes neither presence nor absence of the effect.

## CJC-1295 and body composition: what trials measured

Published phase-1 trials of CJC-1295 with DAC in healthy adults measured biochemical endpoints (plasma GH, IGF-1, proteomic profile shifts) rather than scale weight [1][4][16]. The Alba 2006 murine GHRH-knockout study measured body weight, lean mass, and subcutaneous fat distribution — and reported normalization of all three to control levels after daily CJC-1295 administration in the knockout model [3]. Transient water retention has been described qualitatively in the GHRH-analog class. Long-term human body-composition data for CJC-1295 specifically is limited.

## Fertility data and CJC-1295

No published human fertility trials exist for CJC-1295. Animal reproductive-toxicology data for CJC-1295 specifically is not present in the publicly indexed peer-reviewed literature. The compound acts upstream on the GHRH/GH/IGF-1 axis rather than directly on the hypothalamic-pituitary-gonadal axis, so any reproductive effect would be expected to be indirect — but this is mechanistic reasoning, not data.

## What the safety literature says about CJC-1295

Published phase-1 human trials reported short-term tolerability at the doses tested, with no serious adverse events at single doses of up to 250 µg/kg or at 60 µg/kg weekly or every other week for 49 days [1][16]. The compound is not FDA-approved for any indication [13]. A phase-2 trial of CJC-1295 with DAC in HIV-associated lipodystrophy was halted after a fatal cardiovascular event approximately two hours after the eleventh weekly dose; the trial investigator attributed the event to pre-existing coronary atherosclerosis judged unrelated to study drug, and the sponsor concluded the event was unrelated to the compound, but the development program did not progress past phase 2 [14]. The FDA's 2023 placement of CJC-1295 in Category 2 of the interim 503A bulks list cited peptide-aggregation, immunogenicity, and adverse-event concerns [13]. The compound was removed from Category 2 in September 2024 on nominator withdrawal, which is an administrative outcome rather than a safety clearance [13]. Long-term human safety data does not exist in peer-reviewed literature.

## Regulatory caveats

WADA classifies CJC-1295 under Section S2.2 of the Prohibited List (Peptide Hormones, Growth Factors, Related Substances and Mimetics) as a Growth Hormone Releasing Factor, prohibited at all times in and out of competition for athletes subject to the WADA Code [12]. The compound is widely sold as a 'research chemical' from suppliers outside FDA oversight; analytical studies of seized preparations have confirmed the published sequence and structure but do not provide quality assurance for any specific commercial product [5]. Sustained GH/IGF-1 elevation theoretically raises questions about long-term effects on insulin sensitivity, neoplasia risk, and acromegalic features — these questions are unresolved in the published evidence base for CJC-1295 specifically.

## References

[1] Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. 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. doi:10.1210/jc.2005-1536 https://academic.oup.com/jcem/article/91/3/799/2843281
[3] Alba M, Fintini D, Sagazio A, Lawrence B, Castaigne JP, Frohman LA, Salvatori R. 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):E1290-E1294. doi:10.1152/ajpendo.00201.2006 https://pubmed.ncbi.nlm.nih.gov/16822960/
[4] Sackmann-Sala L, Ding J, Frohman LA, Kopchick JJ. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein profile changes in normal adult subjects. Growth Horm IGF Res. 2009;19(6):471-477. doi:10.1016/j.ghir.2009.03.001 https://www.sciencedirect.com/science/article/abs/pii/S1096637409000409
[5] Henninge J, Pepaj M, Hullstein I, Hemmersbach P. Identification of CJC-1295, a growth-hormone-releasing peptide, in an unknown pharmaceutical preparation. Drug Test Anal. 2010;2(11-12):647-650. doi:10.1002/dta.158 https://pubmed.ncbi.nlm.nih.gov/21204297/
[12] World Anti-Doping Agency. World Anti-Doping Code International Standard — Prohibited List 2025. WADA-AMA. https://www.wada-ama.org/en/prohibited-list
[13] U.S. Food and Drug Administration. FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting — CJC-1295 bulk drug substance nomination. 2023. https://www.fda.gov/media/183819/download
[14] Carter M. Lipodystrophy study halted after patient death. aidsmap (NAM news report on ConjuChem trial CL-2002). 2006. https://www.aidsmap.com/news/jul-2006/lipodystrophy-study-halted-after-patient-death
[16] Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. 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 — multi-dose arm. J Clin Endocrinol Metab. 2006;91(3):799-805. doi:10.1210/jc.2005-1536 https://academic.oup.com/jcem/article/91/3/799/2843281

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The CJC-1295 research record, set out as a specification — not a clinic, not a vendor, not a prescription.