Peptifact

CJC-1295 Side Effects: What 63 Trial Volunteers, One Halted Trial and FDA's 2024 Review Recorded

In the only published human trials, injection-site reactions, headache, flushing and diarrhoea were common and dose-related. A phase 2 trial stopped in 2006 after a participant died of a heart attack. Every human record is of the DAC form; the form most clinics sell has none.

Robert F · Edited by Caroline S · Published 2026-09-24

Illustration: An insulated shipping box with a clear glass vial and foam inserts on a cool grey surface.
Illustration

CJC-1295 side effects are searched by people using a compound whose human safety record fits in three short papers and one trial that never reported. The record is also about a different product from the one most people buy: every human study used CJC-1295 with DAC, the albumin-binding form that lasts about a week, while the vials sold for nightly use alongside ipamorelin are usually the short-acting no-DAC form. This page reports what each source recorded, counts it, and states the gap. It is neither reassurance nor a warning; where a decision is involved, the person to make it with is a clinician. How brands appear on this site is set out on our disclosure page.

The single most useful document is FDA's own. In November 2024 the agency's reviewers wrote a 60-page evaluation of five CJC-1295 substances for its Pharmacy Compounding Advisory Committee, which reads the trial reports line by line (FDA briefing document, December 4, 2024 meeting). The figures below come from it unless another source is named.

The two 2006 trials

Teichman and colleagues ran two randomised, placebo-controlled trials in healthy adults aged 21 to 61, of 28 and 49 days, giving single ascending doses and then two or three weekly or fortnightly injections (Teichman et al., JCEM 2006). The abstract says "no serious adverse reactions were reported" and that the drug was "relatively well tolerated, particularly at doses of 30 or 60 microg/kg". The adverse-event detail behind that sentence is what FDA summarised:

Event Study 1 (single ascending doses) Study 2 (repeated doses)
Any adverse event 33 of 35 treated (94%); 2 of 7 on placebo (29%) not stated as a total
Injection-site reaction (irritation, redness, hardening, pain, itching) about 70% treated; rare on placebo; worse at higher doses every treated volunteer; mild redness in 3 of 4 on placebo
Hives at the injection site almost 30%, not dose-related reported, including on placebo
Headache 63% treated vs 14% placebo 20–80% by dose group vs 50% placebo
Flushing, warmth, transient low blood pressure 30% treated only 40% of low-dose and 100% of high-dose injections, within 30 minutes, gone in 1–2 hours
Diarrhoea or loose stools 43% treated; 45% and 100% at 125 and 250 mcg/kg nausea or abdominal pain 20%
Other one volunteer: transient involuntary leg contractions and loss of coordination; two: dizziness and low blood pressure after the first injection that did not recur

The authors reported no consistent change in blood or urine tests, glucose, liver tests or ECGs. A third study gave one injection of 60 or 90 mcg/kg to young men and recorded a dose-related rise in heart rate and transient redness and tenderness at the site (Ionescu and Frohman, JCEM 2006); a proteomics paper on a subset of the same men did not discuss adverse events (Sackmann-Sala et al. 2009).

FDA's count of everyone ever dosed in a published study: 63 healthy adults, 87% of them men, 73% given a single injection, at 30 to 250 mcg/kg. The doses in those trials, and how far they sit from what clinics now state, are on our CJC-1295 and ipamorelin dosage page.

The trial that stopped

The only registered trial in patients, ConjuChem's phase 2 in people with HIV-associated visceral fat, is listed as terminated on ClinicalTrials.gov with no reason and no results (NCT00267527, read 2026-09-24). What happened is known from press reports that FDA itself cites: 192 people were randomised to weekly injections escalating to 120 or 240 mcg/kg, or placebo. Two hours after an 11th weekly dose, one participant reported chest discomfort, an ECG confirmed an acute myocardial infarction, and the participant died about an hour later. The attending physician's most likely explanation was asymptomatic coronary artery disease with plaque rupture. The company withdrew the compound from clinical development that year, and the data from the other 191 participants have never been published.

That leaves a death that the treating physician did not attribute to the drug, and a trial whose adverse-event tables no one outside the company has seen. Both statements are true, and neither settles the question.

What FDA added in 2024

FDA's reviewers drew four further points out of the record:

  • The no-DAC form has no human safety data at all. "No clinical safety information" was submitted or found for CJC-1295 without DAC. The form usually compounded with ipamorelin is therefore judged on a different molecule's trials.
  • Animal findings at the injection site. In rat and dog studies of the DAC form, injection-site inflammation, haemorrhage and minimal-to-mild necrosis appeared at all doses, with falls in haemoglobin and rises in cholesterol.
  • A pituitary signal in mice. A long-acting GHRH analogue increased pituitary DNA-damage markers in mouse cell cultures and in mice treated for eight weeks (Ben-Shlomo et al., J Clin Invest 2020); FDA read this as evidence of genotoxic potential in growth-hormone-producing cells. No human study has looked.
  • Immunogenicity. Peptides of this kind can provoke antibodies, especially by subcutaneous injection and with aggregates or impurities; FDA said it could not rule this out.

Its overall judgement was that the criteria "weigh against" allowing any CJC-1295 substance in 503A compounding. The nomination now sits among the withdrawn peptide nominations on FDA's category page, explained on our 503A category 2 page.

What FDA's adverse-event database holds

In June 2024 FDA's search of its adverse-event system found two CJC-1295 reports, neither assessable. A query through openFDA on 2026-09-24 returned five reports mentioning CJC-1295, three received in 2026, none recording a death:

Received Products named Reactions recorded
2022-04 gonadorelin (suspect), compounded testosterone/anastrozole, CJC-1295/ipamorelin injection-site abscess; recalled product administered
2022-12 several prescription drugs plus CJC-1295, BPC-157, testosterone, glutathione therapy interrupted
2026-02 CJC-1295/ipamorelin (suspect) drug hypersensitivity; dispensing and preparation errors
2026-04 BPC-157 and CJC-1295 (both suspect) illness; suspected product-quality issue
2026-04 an unapproved product, tesamorelin, retatrutide and CJC-1295/ipamorelin (all suspect) myocardial infarction, acute kidney injury, abnormal liver function, raised glucose, raised heart rate

Four of the five name other products alongside CJC-1295, which is typical of how these compounds are used and makes attribution impossible from a report. Five reports is not a clean record either: compounded and research products have no manufacturer obliged to forward reports. How to read this database is set out on our peptide side effects page.

What the mechanism predicts, and what that is worth

CJC-1295 raises growth hormone and IGF-1 — by 2- to 10-fold and 1.5- to 3-fold after one injection in the 2006 trial. FDA's reviewers pointed out that headache, the event both trials recorded most often after injection-site reactions, is a labelled adverse reaction of growth hormone itself, and that the warnings on every approved growth-hormone label (fluid retention, joint pain, glucose intolerance among them) describe the known risks of raised GH and IGF-1. That is a reason to expect overlap, not a measurement of it; the trials were too short to see those effects. The same reasoning is applied to sermorelin, a GHRH fragment with a labelled programme, on our sermorelin side effects page.

The DAC form's week-long half-life — the longest of any unapproved compound in our half-life chart — also means an injection cannot be withdrawn once given: an adverse reaction to a weekly dose has days of drug behind it, where a no-DAC reaction has minutes.

What the record does not contain

Any safety data for the no-DAC form; any study in women beyond a handful of volunteers; any exposure longer than 49 days; any follow-up of the phase 2 trial's 192 participants; any study of CJC-1295 combined with ipamorelin, which is how it is usually sold; and any comparison of research-market or compounded product with the material ConjuChem made. CJC-1295 is also prohibited at all times under the World Anti-Doping Agency's list. Anyone weighing it, or deciding whether a symptom is related to it, should take that question to a clinician who can see their history.

Sources and dates

Read 2026-09-24: FDA briefing document for the Pharmacy Compounding Advisory Committee meeting of December 4, 2024 (CJC-1295 evaluation dated 2024-11-15), including its human-safety, nonclinical and FAERS sections; PubMed abstracts for Teichman et al. 2006 (PMID 16352683), Ionescu and Frohman 2006 (PMID 17018654), Sackmann-Sala et al. 2009 (PMID 19386527) and Ben-Shlomo et al. 2020 (PMID 32673291); ClinicalTrials.gov record NCT00267527 (the only registry record for CJC-1295 or CJC1295); FAERS via the openFDA drug event endpoint (all five reports opened). The 2006 trial death is reported by aidsmap (July 2006), as cited by FDA; aidsmap's server returned an error when we tried to open it on 2026-09-24, so the details above are FDA's summary of that report. Corrections go to the contact page.

Frequently asked questions

What are the side effects of CJC-1295?

In the two published trials of CJC-1295 with DAC in healthy adults, the most common events were injection-site reactions (redness, hardening, pain, itching, hives), headache, flushing with warmth and sometimes a transient drop in blood pressure, and loose stools or diarrhoea. Most were more frequent at higher doses. The trials were small and mostly single-dose, so they could not detect rare or long-term effects.

Did someone die in a CJC-1295 trial?

Yes. In 2006 a participant in ConjuChem's phase 2 trial in people with HIV-associated abdominal fat had a heart attack two hours after an 11th weekly injection and died. The attending physician's most likely explanation was undiagnosed coronary artery disease. The trial was terminated and its data were never published, so no one outside the company has been able to assess the link.

Are the side effects different for CJC-1295 without DAC?

No one knows from the record. Every published human study used the DAC form, which lasts about a week. FDA's 2024 review found no clinical safety information at all for the no-DAC form, the short-acting version most clinics and blends use. Its side-effect profile is assumed from the DAC trials and from forum reports, not measured.

Why does CJC-1295 cause flushing?

Flushing, warmth and transient low blood pressure are recorded reactions to growth-hormone-releasing hormone analogues, and in the 2006 trial they came within 30 minutes of the injection and cleared within one to two hours. The trials report the reaction; they did not study its mechanism in these volunteers.

Is CJC-1295 safe to use long term?

The record cannot answer that. The longest published exposure was 49 days, in healthy adults, and most received one injection. FDA's 2024 review said the long-term safety profile in humans is unknown and noted a mouse study in which the DAC form induced DNA damage in the pituitary. Anyone weighing it should do so with a clinician.