CJC-1295 Pre-Surgery Hold Window: How Long to Stop Before Your Procedure

At a glance

  • Human studies of CJC-1295 / Three, all DAC form, all healthy volunteers [1]
  • Estimated half-life, one DAC dose / 5.8 to 8.1 days [2]
  • GH after one dose / 2- to 10-fold rise for 6 days or more [2]
  • IGF-I after one dose / 1.5- to 3-fold rise for 9 to 11 days [2]
  • IGF-I after repeated doses / Above baseline up to 28 days [2]
  • Forms FDA describes / CJC-1295 and CJC-1295 DAC [1]

How long a dose keeps GH and IGF-I raised

In two randomized, placebo-controlled trials lasting 28 and 49 days, healthy adults aged 21 to 61 received either one subcutaneous injection or two or three injections given weekly or every two weeks [2]. After a single injection of CJC-1295 DAC, mean GH rose 2- to 10-fold for at least 6 days, mean IGF-I rose 1.5- to 3-fold for 9 to 11 days, and the estimated half-life was 5.8 to 8.1 days [2]. After multiple doses, mean IGF-I stayed above baseline for up to 28 days [2]. The doses tested were single injections of about 30 to 250 micrograms/kg, or two to three doses weekly or every two weeks; they are study doses, not recommended ones [1][2].

A second study measured GH overnight in healthy men aged 20 to 40 before and one week after a single 60 or 90 microgram/kg injection [3]. Between-pulse GH was about 7.5-fold higher, mean GH 46% higher and IGF-I 45% higher, with pulse frequency and size unchanged [3].

Product details that bear on timing

CJC-1295 has no approved product label, so there is no labeled pre-procedure instruction [1]. The form (DAC or non-DAC), the dose per injection and the date of the last injection are the details that determine how the timing data above apply. FDA describes CJC-1295 as a 29-amino-acid GHRH analogue, and CJC-1295 DAC as the same peptide with an extra maleimidopropionic acid-lysine unit that lets it bind blood albumin and last much longer [1][4]. All three published human studies used the DAC form [1].

What FDA has flagged

FDA's posted concerns include possible immunogenicity for certain routes, impurity and characterization problems, serious adverse events including increased heart rate and a systemic vasodilatory reaction, and limited clinical data [5]. In the trials, injection-site reactions occurred in about 70% of treated subjects in study 1 and in all treated subjects in study 2, and headache in 63% versus 14% on placebo in study 1 [1][2]. FDA also said raised GH and IGF-I carries risks listed on approved growth hormone labels, including glucose intolerance and diabetes and fluid retention [1].

Frequently asked questions

How long before surgery should I stop CJC-1295?
We found no published study or regulator guidance that sets a hold period. What the DAC-form studies measured: after one injection the estimated half-life was 5.8 to 8.1 days, with GH up 2- to 10-fold for 6 days or more and IGF-I up 1.5- to 3-fold for 9 to 11 days, and IGF-I above baseline up to 28 days after repeated doses [2].
Does CJC-1295 interact with anesthetic drugs?
CJC-1295 has no approved product label, so there is no labeled interaction information [1]. FDA does list increased heart rate and a systemic vasodilatory reaction among serious adverse events associated with it [5].
Is CJC-1295 FDA approved?
No. FDA found no approved product containing any form of CJC-1295 in the countries it searched and none authorized by the European Medicines Agency [1]. In December 2024 its Pharmacy Compounding Advisory Committee voted 0 yes and 13 no on the free base, 1 yes and 12 no on the acetate, and 0 yes and 13 no on each DAC form [6].
Does the non-DAC form behave differently?
The DAC form carries an extra maleimidopropionic acid-lysine unit that binds blood albumin and extends how long the peptide lasts [1][4]. All three published human studies used the DAC form, and no trial tested the version sold as CJC-1295 without DAC [1].

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. 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. 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
  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):4792-7. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog
  4. Jetté L, Léger R, Thibaudeau K, Benquet C, Robitaille M, Pellerin I, et al. 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. 2005;146(7):3052-8. 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
  5. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  6. U.S. Food and Drug Administration. U.S. Food and Drug Administration
Evidence overview for CJC-1295 Pre-Surgery Hold Window: How Long to Stop Before Your Procedure