Compound monograph
CJC-1295
Also known as: Mod GRF 1-29, DAC:GRF
§1 Definition
CJC-1295 is a synthetic analog of growth-hormone-releasing hormone (GHRH). It exists in two commercially relevant forms with very different pharmacokinetics: without DAC (also sold as "Mod GRF 1-29"), with a half-life of roughly 30 minutes, and with DAC (Drug Affinity Complex), which binds serum albumin and extends the half-life to 5.8-8.1 days. Not FDA-approved for any use; a 2006 human trial of the DAC form was published, but a separate clinical program was terminated after a participant death.
Educational purposes only, not medical advice. Dosing figures below are documented ranges from cited literature, not a recommendation for any individual. Consult a qualified provider before administering anything.
§2 Evidence tier and regulatory status
Evidence tier
3 — Early-phase or limited human data
Early-phase trials, small human studies, or case reports only — not yet late-phase trials.
Not FDA-approved for any use. Nominated to FDA's 503A Category 2 bulk-substances list (substances presenting significant safety risks); the nomination was withdrawn and CJC-1295 was removed from the Category 2 list in September 2024. FDA's Pharmacy Compounding Advisory Committee reviewed CJC-1295 (across its free-base, acetate, DAC free-base, DAC acetate, and DAC-TFA forms) on December 4, 2024, and voted against adding it to the 503A Positive Bulks list, citing nonclinical toxicity findings (pituitary-cell DNA damage and injection-site necrosis in animal studies), immunogenicity risk, and what FDA termed an "unresolved cardiac signal" from a 2006 clinical trial that was terminated after a participant death. This narrative is corroborated across independent secondary summaries and a confirmed FDA docket number (FDA-2024-N-4777); the exact primary-document quote language could not be independently extracted from FDA's PDF in this research pass.
§3 Documented dosing
No approved or standardized human maintenance dose exists — CJC-1295 was never approved as a drug product. The Teichman 2006 human trial (see trialsNote) studied single ascending doses in the 30-250 mcg/kg range of the DAC form specifically; this was a research dose-escalation design, not a recommended dose, so it is not presented as a documented range here.
§4 Reconstitution math
No FDA-approved product exists, so no FDA-labeled reconstitution protocol exists either. General lyophilized-peptide reconstitution practice is commonly applied by research users, but this is not backed by a compound-specific clinical or regulatory source.
- Concentration
- 5000 mcg/mL
- Draw volume
- 0.05 mL
- Syringe units
- 5.0
- Doses per vial
- 40
§5 What the research shows
| Trial | Phase | n | Duration | Endpoint | Result | Source |
|---|---|---|---|---|---|---|
| ConjuChem Phase II trial (HIV-associated lipodystrophy/visceral obesity) | Phase 2 (terminated) | 192 | 12 weeks planned (weekly escalating-dose injections); terminated early | Efficacy for HIV-associated lipodystrophy/visceral obesity (planned; not reached) | Terminated on July 17, 2006 after a participant died, reportedly hours after an eleventh injection. Contemporaneous reporting stated the cause and its relationship to the drug were under investigation; FDA's later 2024 review referred to this as an "unresolved cardiac signal" rather than a cleared, unrelated event. No completed efficacy result exists — this should be read as a trial terminated for a safety concern, not a negative efficacy finding. | [1], [3] |
A separate published trial (Teichman et al., J Clin Endocrinol Metab 2006) examined CJC-1295-with-DAC's growth-hormone and IGF-1 stimulating effects in two randomized, placebo-controlled, double-blind ascending-dose studies (28 and 49 days) in healthy adults ages 21-61, describing it as "safe and relatively well tolerated" particularly at 30-60 mcg/kg, with dose-dependent GH increases (2-10x) lasting 6+ days and IGF-1 increases (1.5-3x) lasting 9-11 days. This trial is not included as a table row above because secondary sources report inconsistent participant counts (21 vs 65) that this research pass could not resolve against the paywalled primary text — no specific n is presented rather than guessing between them.
§6 Safety and reported adverse effects
No published adverse-effect data located.
No detailed adverse-event incidence table was extracted from the Teichman 2006 trial in this research pass (would require full-text access). What is documented: the 2006 ConjuChem trial death described above, and FDA's 2024 nonclinical toxicology findings (pituitary-cell DNA damage, injection-site necrosis) — these are animal/nonclinical findings, not human incidence data.
Contraindications
- No published data located — no human clinical trials have established contraindications for CJC-1295.
Known interactions
- No published data located — no human clinical trials have established drug interactions for CJC-1295.
§7 Storage and handling
- Lyophilized
- No published data located.
- Reconstituted
- No published data located.
§8 Sourcing considerations
- Confirm which variant is actually being sold — without-DAC ("Mod GRF 1-29") and with-DAC products have very different half-lives and are not interchangeable, but listings do not always distinguish them clearly.
- Since CJC-1295 is not FDA-approved for any use, verify the seller provides a Certificate of Analysis from an independent, named third-party lab.
- Be aware FDA's 2024 review cited unresolved safety questions (nonclinical toxicity findings and an unresolved cardiac signal from a terminated human trial) when declining to add this compound to its compounding-eligible substances list.
§9 FAQ
What is CJC-1295?
A synthetic growth-hormone-releasing hormone (GHRH) analog, sold in two forms — without DAC (short-acting, ~30 minute half-life) and with DAC (long-acting, 5.8-8.1 day half-life).
Is CJC-1295 FDA approved?
No. It is not FDA-approved for any use. FDA reviewed it in 2024 and declined to add it to the list of substances eligible for pharmacy compounding, citing nonclinical toxicity findings and an unresolved safety signal from a terminated 2006 human trial.
What is the difference between CJC-1295 with and without DAC?
Without DAC ("Mod GRF 1-29") has a half-life of about 30 minutes. With DAC, which binds to circulating albumin, the half-life extends to 5.8-8.1 days. These are meaningfully different products for dosing-frequency purposes.
Has CJC-1295 been tested in humans?
Yes — a 2006 published trial of the DAC form in healthy adults found dose-dependent growth-hormone and IGF-1 stimulation. A separate clinical trial in an HIV-lipodystrophy population was terminated in 2006 after a participant death; FDA's 2024 review characterized the cause as an unresolved signal rather than a cleared, unrelated event.
Is CJC-1295 safe?
This has not been established. No systematic human adverse-event data has been published, one human trial program was terminated after a death, and FDA's 2024 review cited nonclinical toxicity findings (pituitary-cell DNA damage, injection-site necrosis) among its reasons for declining to add the compound to its compounding-eligible list.
What is CJC-1295 used for in research?
Its studied effect is stimulating growth hormone and IGF-1 secretion via the GHRH receptor. See the trials section above for the specific studies located.
§10 Sources
- [1] FDA-2024-N-4777: CJC-1295 Bulk Drug Substance Review Docket (Category 2 Removal, PCAC Review). U.S. Food and Drug Administration / Regulations.gov, 2024. FDA. https://www.regulations.gov/docket/FDA-2024-N-4777
- [2] 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. Peer-reviewed. https://academic.oup.com/jcem/article-abstract/91/3/799/2843281
- [3] Lipodystrophy Study Halted After Patient Death. aidsmap, 2006. Other. https://www.aidsmap.com/news/jul-2006/lipodystrophy-study-halted-after-patient-death
- [4] CJC1295 Without DAC, CID 91976842. PubChem, National Library of Medicine (NIH), 2026. Other. https://pubchem.ncbi.nlm.nih.gov/compound/CJC1295-Without-DAC