CJC-1295: human evidence, safety and FDA status
Short studies show hormone changes with the DAC form. They do not establish a dependable muscle, sleep or anti-aging benefit for marketed products.
The short answer
CJC-1295 is a synthetic growth-hormone-releasing-hormone analog. Short studies of the DAC form measured hormone changes and pharmacokinetics, not established wellness benefits. It is not FDA-approved; current records do not establish ordinary retail bulk eligibility. Authorized investigation is a separate question.
Definition
CJC-1295 is a synthetic 29-amino-acid analog of growth-hormone-releasing hormone (GHRH 1-29) with substitutions at positions 2, 8, 15 and 27. "CJC-1295 with DAC" adds a linker that binds albumin in the blood, which keeps it circulating for days.
Key takeaways
- One injection of the DAC form raised growth hormone 2- to 10-fold for 6 days or more in healthy adults (Teichman 2006).
- Its half-life in those trials was 5.8 to 8.1 days, far longer than natural growth-hormone-releasing hormone.
- The reviewed published reports do not establish clinical body-composition, sleep or aging benefits. A terminated HIV-lipodystrophy protocol has no posted results.
- FDA lists serious adverse events including increased heart rate, and describes a trial death (from press reports) that the attending physician attributed to coronary disease.
- On December 4, 2024, FDA's compounding advisers voted against all five forms: 13 to 0 for four, 12 to 1 for the acetate.
Key facts
| Fact | Detail |
|---|---|
| Class | GHRH analog peptide, sold as a research compound[1] |
| Forms FDA evaluated | Free base, acetate, DAC free base, DAC acetate, DAC trifluoroacetate[2] |
| FDA approval | Never approved; no approved drug contains it[1] |
| Pharmacy compounding | Current records do not establish ordinary retail bulk eligibility; advisory votes alone do not create or revoke a legal exemption[11] |
| Half-life (DAC form) | 5.8 to 8.1 days in healthy adults[5] |
| People studied | FDA reports 63 healthy-adult exposures; the publication set includes an overlapping 11-person subset, so paper sample sizes should not be added as independent cohorts[1] |
| Sport | WADA Prohibited List, S2.2.4[7] |
CJC-1295 is often marketed with ipamorelin, but the available single-molecule studies do not establish that combination’s benefit or safety. FDA’s primary assessment and final advisory minutes distinguish five reviewed forms [1] [2]. The combination review explains why hormone measurements and a marketed stack are different evidence questions.
CJC-1295 is a long-acting copy of GHRH
CJC-1295 is a lab-made copy of the hormone that tells the pituitary gland to release growth hormone. Your body's own growth-hormone-releasing hormone (GHRH) lasts only minutes in the blood. CJC-1295 changes four of its first 29 amino acids to make it more stable, and the DAC version adds a chemical hook that latches onto albumin, the most common protein in blood [1].
The result is a signal that keeps running for days instead of minutes. CJC-1295 does not contain growth hormone. It raises the body's own output, and with it IGF-1, the blood marker doctors use to track growth-hormone activity [5].
"With DAC" and "no DAC" are different molecules
The published trials used the DAC form; the "no-DAC" product often sold as CJC-1295 or "mod GRF 1-29" is a different molecule, and FDA notes inconsistent naming [1]. FDA treated the two as "two distinct active moieties". It called the naming confusion a safety risk in itself, because a patient "may be dosed with a different BDS than the physician ordered" [1].
In practice, a vial labeled "CJC-1295" could be either one. The half-life and growth-hormone numbers below apply to the DAC form only. Why the pair is sold together, and the DAC question for that pair, are covered in CJC-1295 and ipamorelin.
Human studies show hormone changes, not established wellness benefits
The Teichman and Ionescu reports describe short pharmacokinetic and hormone-response studies in healthy adults. A later Sackmann-Sala publication analyzed serum proteins in 11 men drawn from the Ionescu cohort [8] [1]. This is an additional publication, not a third independent efficacy population.
- Teichman 2006. Two randomized, placebo-controlled trials in healthy adults aged 21 to 61. After one injection, average growth hormone rose 2- to 10-fold for 6 days or more and IGF-1 rose 1.5- to 3-fold for 9 to 11 days. After repeat doses, IGF-1 stayed above baseline for up to 28 days [5].
- Ionescu 2006. Healthy men aged 20 to 40, measured overnight before and a week after one injection. Trough growth-hormone levels rose 7.5-fold (P<0.0001), mean growth hormone rose 46% and IGF-1 rose 45%, while the body's normal on-off pulses were preserved [6].
How long CJC-1295 lasts in the body
In healthy adults the DAC form's half-life was 5.8 to 8.1 days (Teichman 2006) [5]. Half-life is the time it takes for blood levels to fall by half. FDA's review of the same studies reports measurable drug in the blood for 10 to 13 days after an injection [1].
That figure is about the DAC form only. The no-DAC version is a different molecule; the reviewed sources do not establish comparable human pharmacokinetics. Ipamorelin, the peptide it is usually paired with, works through a different receptor, mimicking the hormone ghrelin; its own page covers its record. A half-life is not a guide to drug testing or to how often anyone should take it.
Clinical benefit remains unestablished by the reviewed records
FDA’s summary counts 63 reported healthy-adult exposures across the publications and says 73% involved a single injection [1]. The 11 men in the proteomics report were an Ionescu subset; adding publication sample sizes would therefore overstate the independent research populations. The reviewed reports do not establish clinical muscle, fat-loss, sleep or aging benefits. The terminated HIV-lipodystrophy registry has no posted results [9].
| Claim | Tested in people? | What exists |
|---|---|---|
| Fat loss | Protocol exists; benefit unestablished | Terminated HIV-lipodystrophy study, no posted results [9] |
| More muscle | Not established by reviewed studies | GH/IGF-1 changes are not strength or body-composition evidence |
| Better sleep | Not established by reviewed studies | Overnight hormone sampling is not a validated clinical sleep endpoint |
| Anti-aging | Not established by reviewed studies | Short hormone/PK and proteomic reports cannot establish aging or lifespan benefit |
| Study | People | What it measured | Result |
|---|---|---|---|
| Teichman 2006 [5] | Healthy adults, 21 to 61 | Growth hormone, IGF-1, half-life | GH up 2 to 10x for 6+ days; half-life 5.8 to 8.1 days |
| Ionescu 2006 [6] | Healthy men, 20 to 40 | Overnight GH pulses | Trough GH up 7.5x; pulses preserved |
| Sackmann-Sala 2009 [8] | 11 men, subset of Ionescu cohort | Serum protein analysis | Biological measurements, not clinical benefit or a new independent cohort |
| HIV-lipodystrophy protocol [9] | Registry target 120; FDA’s press-report summary says 192 enrolled | Body-fat outcome planned | Terminated, no posted results; press and registry counts must not be silently conflated |
Safety: what FDA found
FDA's safety-risks page states that it "has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction", and that "available clinical data are limited" [3]. The details come from FDA's review of the two published trials [1]:
- Injection-site reactions (irritation, redness, hardening, pain or itching) in about 70% of people on the drug in the first trial, and in everyone in the second.
- Hive-like rashes at the injection site in almost 30%.
- Headache in 63%, against 14% on placebo, in the first trial.
- Flushing, warmth and brief drops in blood pressure; in the second trial, flushing affected 40% after lower doses and 100% after higher ones.
- A dose-dependent rise in heart rate in the Ionescu study.
FDA's briefing describes, from press reports, one death from heart attack in an unpublished HIV-lipodystrophy trial; the attending physician attributed it to existing coronary disease, and the trial was stopped [1]. FDA was careful about the source: the account comes from internet reports, not a published paper. It is a reason the record is thin, not proof the drug caused the death. For safety questions about the pair, see Is CJC-1295 with ipamorelin safe?
FDA assessment and advisory votes have separate legal roles
CJC-1295 is not FDA-approved. FDA’s assessment identified no applicable monograph and no component of an approved drug for the reviewed forms [1]. Current 503A regulation and interim records do not establish ordinary retail bulk eligibility [11] [4]. Advisory recommendations are nonbinding; the exact final minutes nevertheless provide a primary record of the votes.
| Form | Yes | No | Abstain |
|---|---|---|---|
| CJC-1295 (free base) | 0 | 13 | 0 |
| CJC-1295 acetate | 1 | 12 | 0 |
| CJC-1295 DAC (free base) | 0 | 13 | 0 |
| CJC-1295 DAC acetate | 0 | 13 | 0 |
| CJC-1295 DAC trifluoroacetate | 0 | 13 | 0 |
"Yes" was a vote to place the form on the 503A bulks list. Source: FDA meeting minutes, approved February 21, 2025 [2].
The final minutes were approved in February 2025 and document the five ballots [2]. A broader peptide-policy notice is pending OIRA review; it does not publish final terms or establish eligibility for CJC-1295 [10].
A marketed product needs its own applicable legal pathway
A prescription or “research use only” label does not establish an applicable compounding exemption. Properly authorized clinical investigation has separate manufacturing, nonclinical, protocol and oversight requirements [12]. Trial registration alone does not establish every authorization. Neither the advisory vote nor a pending policy supplies an approved product.
Related molecules have different records. Sermorelin has historical approvals that do not approve current compounded products. Tesamorelin has approved Egrifta formulations for excess abdominal fat in adults with HIV-associated lipodystrophy. These differences do not establish a head-to-head superiority claim. Compare the scoped sermorelin comparison and tesamorelin comparison.
CJC-1295 is banned in sport at all times
WADA's Prohibited List names CJC-1295 under S2.2.4, among growth-hormone-releasing factors and GHRH analogs, alongside sermorelin and tesamorelin [7]. It is prohibited in and out of competition.
Terms used on this page
Research on CJC-1295
A higher hormone level is not the same as a better health outcome
Learn to distinguish laboratory changes from patient benefits when reading growth-hormone peptide studies and clinic claims.
What does CJC-1295 with ipamorelin do? What's studied, what isn't, and FDA's votes
Two peptides target different growth-hormone signals. Compare the measured individual-drug findings, combination evidence gaps and current FDA records.
Does CJC-1295 with ipamorelin work? What has actually been tested
Clinics sell CJC-1295 and ipamorelin together for fat loss, muscle, sleep and recovery. Here is selected human reports and current registered research, and what each one measured.
Is CJC-1295 with ipamorelin safe? What the trials and FDA's reviews show
Small individual-drug studies and uncertain adverse-event reports cannot establish the safety of a combination. Read the source populations and study limits.
CJC-1295 compared
CJC-1295 vs sermorelin: the same idea, a different standing with FDA
CJC-1295 was built to fix sermorelin's main limit, its short life in the blood. It never made it to approval. Sermorelin did, then left the market, and reaches patients today through compounding.
CJC-1295 vs tesamorelin: two GHRH copies, one approved drug
Both were developed as longer-acting versions of the same brain hormone, and both were tested in people with HIV. One became Egrifta. The other's patient trial was stopped and never published.
Frequently asked
- Is CJC-1295 FDA approved?
- No. CJC-1295 has never been approved, no approved drug contains it, and FDA's compounding advisers voted against all five of its forms in December 2024.
- Is CJC-1295 a steroid?
- No. It is a peptide, a short chain of amino acids, that copies the hormone telling the pituitary to release growth hormone. It is not a steroid and does not contain growth hormone.
- What's the difference between CJC-1295 with and without DAC?
- They are different molecules. The DAC version binds albumin and lasts for days; the no-DAC version, often sold as mod GRF 1-29, does not. The published trials used the DAC form, and FDA flagged inconsistent naming as a risk.
- Is CJC-1295 the same as sermorelin or tesamorelin?
- No. They are different molecules with different clinical and regulatory records. Historical sermorelin approvals do not approve present compounded products; Egrifta formulations have a specific HIV-lipodystrophy indication. No head-to-head superiority follows from sharing a hormone pathway.
- Can you buy CJC-1295 legally?
- Current records do not establish an FDA-approved product or ordinary retail bulk-compounding eligibility. Properly authorized investigation is separate; a prescription, research label or registry entry alone does not establish authorization.
Sources
- [1] FDA. Briefing Document: CJC-1295-Related Bulk Drug Substances. Pharmacy Compounding Advisory Committee, December 4, 2024. FDA
- [2] FDA. Pharmacy Compounding Advisory Committee, December 4, 2024: final meeting minutes (approved February 21, 2025) (2025). FDA
- [3] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 04/22/2026) (accessed 2026). FDA
- [4] FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated May 14, 2026) (2026). FDA
- [5] Teichman SL. 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). PMID 16352683
- [6] Ionescu M. 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). PMID 17018654
- [7] WADA: 2026 Prohibited List, S2.2.4 (2026). Source
- [8] Sackmann-Sala L. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein profile changes in normal adult subjects (2009). PMID 19386527
- [9] ClinicalTrials.gov: CJC-1295 HIV-lipodystrophy protocol; terminated, no posted results (accessed 2026). Source
- [10] OIRA pending review: Interim Access Policy for Compounding Using Certain Peptides (accessed 2026). Source
- [11] Current 21 CFR 216.23: 503A bulks regulation (accessed 2026). Source
- [12] FDA: Investigational New Drug framework (accessed 2026). FDA