CJC-1295 — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for CJC-1295 as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Injection-site reaction | — | — | — | Reported in phase 1 |
| Flushing | — | — | — | Reported |
| Fluid retention | — | — | — | Expected class effect of growth-hormone-axis stimulation |
| Glucose intolerance | — | — | — | Expected class effect; not systematically measured in the available human data |
| Arthralgia | — | — | — | Expected class effect |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Not established — no marketing authorisation exists in any jurisdiction
§4.3Warnings and precautions
- No compound under this name holds a marketing authorisation anywhere
- A phase 1 programme in a related indication was discontinued following a serious adverse event in one participant, and the Institute records that this history is rarely disclosed in supply-side material
- Continuous rather than pulsatile GHRH receptor stimulation has not been shown to be safe over extended periods
- Growth-hormone-axis stimulation in undiagnosed malignancy is a theoretical concern
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- 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. Journal of Clinical Endocrinology & Metabolism 2006;91(3):799–805. doi:10.1210/jc.2005-1536 · PMID 16352683
- 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. doi:10.2165/00063030-199912020-00007 · PMID 18031173
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.