CJC-1295 with DAC
Evidence: C/DGH Axis / Body Composition
Evidence Snapshot
What this grade covers
C for limited early human pharmacology and biomarker evidence showing prolonged GH/IGF-1 effects and preserved pulsatility; D for therapeutic efficacy, body-composition outcomes, recovery, performance, anti-aging, longevity, and long-term safety because adequate controlled clinical outcome evidence is absent.
Regulatory Context
Investigational and not FDA-approved. FDA’s 2024 evaluation concluded that the available information weighed against adding CJC-1295-related bulk substances, including DAC forms, to the 503A Bulks List; FDA also lists CJC-1295 among substances associated with potential significant safety risks in compounding.
Research Takeaway
CJC-1295 DAC was engineered as an albumin-binding, long-acting GHRH analog.
See all 11 evidence claims →Quick Summary
CJC-1295 with DAC is a long-acting GHRH analog engineered to form a covalent conjugate with circulating albumin. Small early human studies demonstrated prolonged increases in GH and IGF-1 and preserved GH pulsatility, but no approved indication or established clinical-benefit program followed. Current evidence is largely pharmacokinetic, pharmacodynamic, preclinical, and regulatory rather than outcome-based.
Mechanism & Research Overview
CJC-1295 with DAC is a modified GHRH analog containing an albumin-binding drug-affinity-complex moiety. The DAC modification was designed to prolong systemic exposure while retaining GHRH-receptor activity. Small early human studies evaluated sustained GH and IGF-1 changes; they were not long-term therapeutic-outcome trials.
Evidence Grade Breakdown
A single letter grade can't capture how evidence quality differs across approved use, off-label use, and unsupported claims. The categories below break that down -- none of them grade this compound "overall."
Overall Research Grade
The overall C/D grade reflects a split profile: limited but real early human pharmacology and biomarker evidence (prolonged GH/IGF-1 effects, preserved pulsatility) supports the higher end, while the complete absence of controlled human outcome-efficacy evidence, dedicated safety trials, and long-term data for body composition, recovery, performance, anti-aging, or longevity keeps the grade at the lower end for any therapeutic-use interpretation.
CHuman Pharmacology/Biomarker Evidence
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Human Pharmacology/Biomarker Evidence
Small early human studies (Teichman 2006, Ionescu-Frohman 2006, and a third GH/IGF-1 axis protein-profile study) showed prolonged increases in GH and IGF-1 and preserved GH pulsatility after CJC-1295 DAC exposure, but sample sizes were small and only one source describes randomized controlled trials.
DHuman Therapeutic Outcome Efficacy
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Human Therapeutic Outcome Efficacy
FDA did not identify a human study evaluating any reviewed CJC-1295 form for growth-hormone deficiency, and the available healthy-adult studies did not evaluate fat loss, muscle gain, strength, physical performance, injury recovery, sleep quality, anti-aging outcomes, or longevity. GH/IGF-1 biomarker increases must not be presented as proof of these outcomes.
DSafety Evidence
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Safety Evidence
Safety evidence comes from FDA regulatory review rather than a dedicated controlled human safety trial: FDA identified increased heart rate, systemic vasodilatory reactions, immunogenicity, and impurity-characterization concerns, plus additional adverse-effect reports and nonclinical genotoxicity/local-tissue signals; no pediatric safety dataset exists and long-term controlled safety data are absent.
CPreclinical/Mechanistic Evidence
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Preclinical/Mechanistic Evidence
A GHRH-knockout mouse study and a rat receptor-activation/albumin-bioconjugate characterization study support the DAC mechanism and prolonged exposure, but preclinical data alone cannot establish human efficacy or long-term safety.
BRegulatory/Product-Identity Evidence
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Regulatory/Product-Identity Evidence
FDA's 2024 evaluation and the December 2024 PCAC review (0 votes for inclusion, 13 against, advisory and nonbinding) document CJC-1295 DAC free base, DAC acetate, and DAC trifluoroacetate as distinct bulk drug substances, chemically distinct from and not interchangeable with CJC-1295 without DAC.
Evidence reviewed
- Randomized human trials
- 1
- Regulatory documents
- 5
- Preclinical studies
- 2
- Primary sources reviewed
- 11
Study counts describe the reviewed evidence base. They do not independently determine evidence quality.
How MitoCore grades evidence
Grade definitions
- A
- Strong and directly applicable evidence, generally including regulatory support or multiple high-quality replicated human trials for the exact claim and population.
- A-
- Strong human evidence with limited uncertainty, narrower applicability, or incomplete replication.
- B+
- Moderately strong evidence with meaningful human support but important scope, duration, safety, or generalizability limitations.
- B
- Credible evidence with notable uncertainty, limited replication, or mixed results.
- C
- Preliminary or inconsistent evidence, usually limited human data or strong indirect evidence.
- D
- Weak, indirect, population-limited, or largely unsupported evidence for the specific use being graded.
- F
- No credible supporting evidence, evidence contradicting the claim, or claims based primarily on speculation or marketing.
Confidence definitions
- High
- The evidence classification is unlikely to change substantially with ordinary additional research.
- Moderate
- The classification is reasonably supported but could change with additional high-quality evidence.
- Low
- The evidence base is sparse, indirect, inconsistent, or dependent on uncertain assumptions.
- Very Low
- The evidence base is extremely limited, speculative, or unsuitable for firm conclusions.
Scope
The grade evaluates the evidence supporting the specific category or claim. A grade does not evaluate product purity, supplier quality, personal suitability, treatment appropriateness, individual outcomes, legality, or medical safety for a specific person.
These grades and confidence levels describe the research evidence itself. They are not medical recommendations, and they do not evaluate any specific product, supplier, or individual's situation.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
CJC-1295 DAC was engineered as an albumin-binding, long-acting GHRH analog.
Sources: Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog; Prolonged stimulation of growth hormone and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of growth hormone-releasing hormone, in healthy adults
Supported
Small human studies showed prolonged increases in GH and IGF-1 after CJC-1295 DAC exposure.
Sources: Prolonged stimulation of growth hormone and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of growth hormone-releasing hormone, in healthy adults; Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog
Supported
GH pulsatility was preserved while basal and mean GH and IGF-1 increased in a small study of healthy men.
Supported
CJC-1295-related DAC and non-DAC substances are chemically distinct and not interchangeable.
Sources: FDA Evaluation of CJC-1295-Related Bulk Drug Substances for the 503A Bulks List
Supported
FDA identifies increased heart rate, systemic vasodilatory reaction, immunogenicity, and impurity-characterization concerns in the compounding context.
Sources: Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks — CJC-1295; FDA Evaluation of CJC-1295-Related Bulk Drug Substances for the 503A Bulks List
Supported
FDA distinguishes CJC-1295 DAC free base, CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate as separate bulk drug substances that may have different physical, chemical, pharmacokinetic, safety, and efficacy properties; these salt forms must not be treated as interchangeable with each other or with CJC-1295 without DAC.
Sources: FDA Pharmacy Compounding Advisory Committee Review of CJC-1295-Related Bulk Drug Substances
Supported
At the December 4, 2024 Pharmacy Compounding Advisory Committee meeting, CJC-1295 DAC free base, DAC acetate, and DAC trifluoroacetate each received 0 votes for inclusion and 13 votes against inclusion on the 503A Bulks List. The vote was advisory and nonbinding, and no final FDA rule adding these substances was identified as of the research cutoff.
Supported
A third small human study examined CJC-1295 DAC effects on GH/IGF-1 axis protein profiles, consistent with sustained pharmacodynamic activity.
Supported
FDA briefing materials note an unpublished development report describing a CJC-1295 study in people with HIV lipodystrophy that was reportedly stopped after a participant death; the available public information does not establish causality or provide an interpretable efficacy dataset.
Sources: FDA Evaluation of CJC-1295-Related Bulk Drug Substances for the 503A Bulks List
Supported
FDA did not identify a human study evaluating any reviewed CJC-1295 form in adults or children with growth-hormone deficiency. The available healthy-adult studies did not evaluate fat loss, muscle gain, strength, physical performance, injury recovery, sleep quality, anti-aging outcomes, or longevity; GH/IGF-1 biomarker increases in healthy adults must not be presented as proof of these outcomes or as equivalence to approved growth-hormone-deficiency therapies.
Sources: FDA Evaluation of CJC-1295-Related Bulk Drug Substances for the 503A Bulks List
Supported
In 2025, FDA enforcement records documented a Class II recall involving a compounded product labeled 'CJC-1295 Injectable' (Thrive Health and Wellness, LLC dba Thrive Health Solutions) because of lack of assurance of sterility.
Does not establish
Evidence boundary: The FDA enforcement record does not independently specify that the recalled product was the DAC-conjugated form; its association here with CJC-1295 with DAC follows the naming convention used for this research page and should not be interpreted as analytical confirmation of the recalled product's exact CJC-1295 form. The recall concerns specific compounded product lots and sterility assurance, not evidence that CJC-1295 DAC as a molecular entity is intrinsically contaminated or toxic.
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Higher-Priority Safety Consideration
FDA identified increased heart rate and systemic vasodilatory reactions among serious adverse events associated with CJC-1295; clinical data remain limited.Higher-Priority Safety Consideration
FDA documented inconsistent naming across free-base, salt, DAC, and non-DAC forms. Misidentification can lead to the wrong active moiety or formulation being supplied or studied.Higher-Priority Safety Consideration
FDA highlighted aggregation, peptide-related impurities, incomplete characterization, sterility/endotoxin considerations, and potential immunogenicity for compounded injectable products.Safety Consideration
FDA-reviewed reports also describe headache, nausea and abdominal discomfort, diarrhea, flushing and warmth, transient urticarial rash, dizziness, involuntary muscle contractions, and impaired coordination.Safety Consideration
The DAC form has prolonged pharmacodynamic effects. Long-term consequences of repeated sustained GH/IGF-1 elevation have not been established in adequate controlled studies.Safety Consideration
Human studies primarily assessed pharmacokinetics and hormone responses; they do not demonstrate improved body composition, recovery, longevity, or treatment outcomes.Safety Consideration
Repeated-dose animal studies showed local hemorrhage, inflammation, and necrosis signals, and an FDA-reviewed in-vitro experiment showed a genotoxicity signal. No pediatric safety dataset exists, and repeated-dose/chronic-use evidence remains inadequate.
Research Areas Being Studied
Research areas discussed on this page reflect the GH Axis / Body Composition category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- CJC-1295 Effects on GH/IGF Axis Protein Profiles (2009):
- Prolonged stimulation of growth hormone and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of growth hormone-releasing hormone, in healthy adults (2006):
- Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog (2006):
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| CJC-1295 Effects on GH/IGF Axis Protein Profiles | 2009 | Healthy adults | Small human study examining CJC-1295 DAC effects on GH/IGF-1 axis protein profiles, consistent with sustained pharmacodynamic stimulation of the axis; not an outcome/efficacy trial. | ||
| Prolonged stimulation of growth hormone and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of growth hormone-releasing hormone, in healthy adults | 2006 | Healthy adults ages 21-61 (two randomized controlled trials) | Human randomized trials showed prolonged GH and IGF-I increases after the long-acting DAC-containing CJC-1295 development compound. FDA specifically notes these clinical references concern CJC-1295 DAC, so they must not be used as direct human efficacy evidence for CJC-1295 free base/no-DAC.
| ||
| Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog | 2006 | Healthy men ages 20-40 | Pulsatile GH release was preserved; basal GH increased 7.5x, mean GH increased 46%, and IGF-1 increased 45%.
|
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Once-daily administration of CJC-1295, a long-acting growth hormone-releasing hormone (GHRH) analog, normalizes growth in the GHRH knockout mouse | 2006 | GHRH-knockout mice | Normalized body weight and length with daily dosing; less-frequent dosing (every 48-72 hours) gave only a partial effect.
| ||
| Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog | 2005 | Rat pharmacology and albumin-bioconjugation experiments | The study identified a long-acting albumin-binding CJC-1295 conjugate and characterized prolonged activity. Because the paper concerns the albumin bioconjugate, it belongs with the DAC form rather than the non-DAC page. | Preclinical pharmacology does not establish human safety. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| 2026 World Anti-Doping Agency Prohibited List | 2026 | Anti-doping regulatory standard | WADA lists growth-hormone-releasing factors and secretagogues, including CJC-1295, sermorelin, GHRP-2, GHRP-6, and examorelin/hexarelin, as prohibited in sport. | Anti-doping status is not a clinical safety or efficacy determination. | |
| Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks — CJC-1295 | 2026 | FDA compounding safety summary | FDA states that compounded CJC-1295 may present immunogenicity and impurity-characterization concerns and that available clinical data are limited. | FDA identifies serious adverse events associated with CJC-1295, including increased heart rate and systemic vasodilatory reaction. | |
| FDA Evaluation of CJC-1295-Related Bulk Drug Substances for the 503A Bulks List | 2024 | FDA chemistry, safety, effectiveness, and compounding evaluation | FDA distinguished CJC-1295 free-base/acetate from DAC forms, documented inconsistent nomenclature, found that none are components of FDA-approved drugs, and concluded that the available criteria weighed against placement on the 503A Bulks List. | FDA discussed peptide aggregation, impurities, immunogenicity, injection-product quality, acute adverse reactions, preclinical concerns, and limited clinical data. | |
| FDA Pharmacy Compounding Advisory Committee Final Summary Minutes — CJC-1295-Related Bulk Drug Substances (December 4, 2024) | 2024 | FDA advisory-committee proceedings | At the December 4, 2024 meeting, CJC-1295 DAC free base, CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate each received 0 votes for inclusion and 13 votes against inclusion on the 503A Bulks List. | Advisory committee votes are nonbinding. No final FDA rule adding these substances to the 503A Bulks List was identified as of the research cutoff (2026-07-26). | |
| FDA Pharmacy Compounding Advisory Committee Review of CJC-1295-Related Bulk Drug Substances | 2024 | N/A — regulatory committee determination | FDA’s briefing evaluation concluded that the criteria weighed against placing the evaluated CJC-1295 free-base, acetate, DAC, DAC-acetate, and DAC-TFA substances on the 503A Bulks List. The advisory committee’s recommendation is non-binding and is not itself an approval or final enforcement decision. | ||
| A Study to Evaluate CJC-1295 in HIV Patients With Visceral Obesity | 2006 | Trial registry record; study terminated | The trial was registered to evaluate CJC-1295 in HIV-associated visceral obesity. No completed efficacy result should be inferred from the registry entry.
| A trial registry is not a completed-results publication. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational research summary only. This page does not provide medical advice, treatment guidance, product-quality assurance, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Content pending review. Last updated 2026-07-26.
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