What isCJC-1295FDA Status, Evidence and Risks (2026)
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Off FDA's Category 2 list since Sept 2024 (nomination withdrawn), voted down by FDA's advisory panel for the 503A bulks list in Dec 2024 across all 5 forms, and not approved by FDA for any use. Source: FDA, Category 2 page current as of Apr 22, 2026 1, and Dec 4, 2024 voting results 2.
Part of the Sommar Peptide Guide. CJC-1295 is sold online as a long-acting growth hormone peptide, usually in a "stack" with ipamorelin.
What CJC-1295 is
CJC-1295 is a synthetic copy of growth hormone-releasing hormone (GHRH), the signal the brain uses to cue the pituitary. It keeps 29 amino acids of GHRH and swaps 4 of them, at positions 2, 8, 15 and 27 3. It was developed by a company called ConjuChem 3.
It comes in two versions, and the labels online are a mess.
| CJC-1295 with DAC | CJC-1295 without DAC | |
|---|---|---|
| What's different | A chemical add-on (DAC, "drug affinity complex") meant to latch onto albumin in the blood 3 | The 29-amino-acid peptide alone 3 |
| Names seen on labels | CJC-1295 DAC | "Mod GRF 1-29," "tetra-substituted GRF 1-29," or plain "CJC-1295" 3 |
| How long it lasts in people | Estimated half-life 5.8 to 8.1 days in healthy adults 4 | We found no human data |
| Human studies FDA found | 3, all in healthy subjects 3 | None 3 |
| Dec 2024 panel vote, 503A list | 0 to 13 for each of 3 forms 2 | 0 to 13 (free base), 1 to 12 (acetate) 2 |
FDA says "direct evidence is lacking" that the DAC add-on is what makes it last longer 3. FDA also flagged the naming itself as a risk: a patient could get a different substance than the one ordered 3.
Where FDA stands
- Sept 2024: FDA took CJC-1295 off Category 2 after its nomination was withdrawn 1,5.
- Dec 4, 2024: FDA reviewed 5 forms on its own initiative, because the nominations were unclear about which one they meant. Staff said the evaluation criteria "weigh against" all 5 for the 503A bulks list 3. The advisory committee agreed. Votes ran from 0 to 13 up to 1 to 12 2.
- Today: not on Category 2, not on the 503A bulks list, not approved by FDA for any use.
Coming off Category 2 never meant approval. It happened because the nomination was withdrawn. Are peptides legal? has the full explanation.
Not in the HHS policy. On Oct 28, 2026, HHS filed an interim enforcement discretion policy for compounding six peptides: BPC-157, TB-500, MOTS-c, epitalon, semax and KPV 6. CJC-1295 is not one of them, so its status above stands, as of Oct 29, 2026. The FDA Peptide Tracker logs every change.
What the research shows
The human data are three published studies, all in healthy subjects, all using the DAC version 3. FDA found no studies in patients with any disease 3.
The best known, Teichman 2006, gave healthy adults single and repeated injections 4:
- One injection raised average growth hormone 2- to 10-fold for 6 days or more.
- IGF-1, the marker most tied to growth hormone, rose 1.5- to 3-fold for 9 to 11 days.
- With repeated doses, IGF-1 stayed above baseline for up to 28 days.
- No serious adverse reactions were reported in that study.
That shows the drug changes hormone levels in healthy people. It says nothing about health outcomes, and nobody has run a trial to find out.
Two trials ended early:
- 2006: ConjuChem withdrew CJC-1295 DAC from clinical trials "after the death of a subject involved in a phase 2 trial" 3. FDA's briefing does not state the cause of death or whether the drug caused it.
- HIV-related belly fat: a registered trial in this group was terminated early. FDA did not say which form it used 3.
Side effects and FDA's concerns
FDA's stated concerns, from its Category 2 page 1:
- Immune reactions. Possible immunogenicity for some routes.
- Impurities. "Complexities with regard to peptide-related impurities and API characterization."
- Serious events. "FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction," meaning blood vessels widening throughout the body.
- Thin data. "Available clinical data are limited."
From FDA's 2024 briefing 3:
- In rats: less eating, soft stools and less activity. With repeated doses, lower red blood cell counts, bleeding and inflammation at the injection site, and heavier livers.
- In dogs: vomiting, injection-site irritation and higher cholesterol.
- DNA damage signals: studies in mouse pituitary cells and in mice found DNA damage with the DAC substances.
- Missing studies: no reproductive or cancer studies for most forms.
- The salt: one DAC form is a trifluoroacetate (TFA) salt. FDA noted TFA's known toxicity and that it may raise immune risk.
Animal findings do not always carry over to people. They are also most of what exists.
The "stack" myth
Online, CJC-1295 is usually sold with ipamorelin. Sellers pitch CJC-1295 for the GHRH signal and ipamorelin for the ghrelin-receptor signal.
A stack has no FDA status of its own. Each peptide keeps its own record:
- CJC-1295: panel said no, Dec 2024 2.
- Ipamorelin: still on Category 2 for outsourcing facilities, and the panel voted 0 to 12 against it in Oct 2024 1,7.
We found no published trial of the pair.
Sermorelin also acts on the GHRH receptor. A shared target does not mean the same drug or the same status. Sermorelin vs Ipamorelin covers how sermorelin and ipamorelin differ. For another Shelf 1 peptide, see GHRP-2.
Why it's sold online anyway
CJC-1295 is easy to buy from sites that label it "research use only" or "not for human consumption." That label is the seller saying the product is not for people.
No prescriber reviews your health history. No licensed pharmacy compounds it for one patient or checks it for human use.
FDA said the certificates of analysis it saw showed no impurity or endotoxin controls 3. Prescription vs Research Peptides has more.
Asked a lot.
The sources.
- FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of Apr 22, 2026). Read it
- FDA. Pharmacy Compounding Advisory Committee, Dec 4, 2024, voting results. Read it
- FDA. Pharmacy Compounding Advisory Committee, Dec 4, 2024, briefing document: CJC-1295. Read it
- Teichman SL, et al. 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. Read it
- Reed Smith. FDA removes certain peptide bulk drug substances from Category 2 (2024). Read it
- HHS. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496, FR Doc 2026-22192 (filed for public inspection Oct 28, 2026; scheduled to publish in the Federal Register Oct 30, 2026). Read it
- FDA. Pharmacy Compounding Advisory Committee, Oct 29, 2024, meeting minutes. Read it
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