CJC-1295 With DAC: Identity, Evidence, and Status
CJC-1295 with DAC is an albumin-binding analogue of the first 29 amino acids of human growth hormone-releasing hormone. The letters DAC refer to a drug-affinity-complex modification: the peptide carries a reactive group designed to form a stable association with serum albumin.
That modification is not a minor naming detail. CJC-1295 with DAC and CJC-1295 without DAC are different active moieties. The long-duration cell, animal, and healthy-volunteer studies discussed on this page concern the DAC active moiety. They must not be used to assign the same persistence, pharmacokinetics, or hormone response to the no-DAC material.
The human evidence is small and focused on pharmacokinetics and hormone measurements rather than patient benefit. The only registered patient study is terminated and has no posted results. This page does not provide medical advice or use instructions, and it does not validate a Serum Research material.
Evidence state at a glance
| Field | Current record |
|---|---|
| Molecular class | Modified GHRH(1-29) analogue with an albumin-binding group |
| FDA GSRS sequence | YaDAIFTQSYRKVLAQLSARKLLQDILSRK; lower-case a denotes D-alanine |
| FDA UNII | 62RC32V9N7 |
| Defining DAC feature | A C-terminal lysine bearing an N-epsilon-3-maleimidopropionamide group |
| Bulk forms FDA reviewed | DAC free base, DAC acetate, and DAC trifluoroacetate |
| Direct human evidence | Small healthy-volunteer pharmacokinetic and hormone studies; no demonstrated patient benefit |
| Registered patient trial | NCT00267527; terminated; no results posted |
| U.S. FDA status | No reviewed form was a component of an FDA-approved drug in FDA’s 2024 assessment |
| Evidence reviewed | August 27, 2026 |
| Evidence tier | What belongs in it | Editorial boundary |
|---|---|---|
| Tier 1 | Direct structural, cell, and animal work on the DAC active moiety | Model-specific identity and mechanism only |
| Tier 2 | Small human DAC studies | Pharmacokinetic and hormone measurements, not demonstrated patient benefit |
| Tier 3 | NCT00267527 | Terminated registry record with no posted results; no outcome conclusion |
| Excluded | No-DAC CJC-1295, an unspecified CJC/IPA blend, or an unmatched catalog lot | Do not transfer the DAC findings |
What makes the DAC form different?
FDA’s substance record represents CJC-1295 as a 30-residue chain built from a tetrasubstituted GHRH(1-29) core and a modified terminal lysine.[1][2] In the defining primary paper, the lysine carried a maleimide-containing group intended to react with the free thiol at cysteine 34 of serum albumin.[3]
The same paper reported an albumin-associated CJC-1295 signal in rat plasma and longer persistence than the unmodified comparator. The albumin-binding group is therefore central to the molecule studied, not an optional formulation feature.
By contrast, the no-DAC active moiety lacks that added maleimidopropionamide-lysine group. It has its own identity page because DAC results are not direct evidence for no-DAC material.
“With DAC” still does not complete the specification. FDA reviewed a free base, acetate, and trifluoroacetate form. A catalog label should identify which bulk form is present, how the amount is calculated, and which analytical record supports that assignment.
What was studied in cells and animals?
Jetté and colleagues formed albumin conjugates outside the body, tested growth-hormone secretion in cultured rat pituitary cells, and evaluated candidate molecules in rats.[3] Their selected CJC-1295 construct remained detectable longer than native GHRH(1-29) in that experimental system and produced an albumin-associated signal.
Alba and colleagues studied CJC-1295 in mice with a deleted GHRH gene.[4] They reported interval-dependent differences in growth, body composition, and pituitary measurements. The study addressed a specific genetic mouse model. It does not establish a human outcome, and the report did not make the exact free-base, acetate, or TFA form clear.
These papers support the DAC active moiety’s albumin-binding design and activity in the tested systems. They do not validate a no-DAC peptide, a blend, or a commercial vial.
What has been reported in healthy adults?
Teichman and colleagues reported two randomized, placebo-controlled, ascending-exposure studies in healthy adults.[5] The measured outcomes included CJC-1295 pharmacokinetics and circulating growth hormone and IGF-I. The authors reported prolonged changes in those measurements.
The studies did not test symptom improvement, body composition, disease outcomes, exercise performance, recovery, sleep, or longevity. They were short and not designed to characterize uncommon or long-term harms.
Ionescu and Frohman examined overnight growth-hormone pulsatility in healthy men before and after CJC-1295.[6] Mean and trough hormone measurements changed, while pulse frequency and pulse magnitude did not significantly change. That null finding matters: the result was more specific than a general claim that every feature of hormone secretion increased.
A later exploratory paper analyzed serum proteins from 11 men drawn from the earlier work.[7] It was a secondary proteomic analysis, not an independent effectiveness trial.
FDA’s review concluded that these reports appear to concern the DAC active moiety, but the exact DAC free-base, acetate, or TFA form is unclear.[1] The data therefore cannot establish that every material sold under the same shorthand is equivalent.
What happened to the registered patient study?
ClinicalTrials.gov lists one Phase 2 study of “CJC 1295” in people with HIV-associated visceral obesity, NCT00267527.[8] The record says the trial was terminated, enrolled 120 participants, and has no results posted. It does not identify the form in the U.S. record.
FDA noted that a cross-referenced European record identified a TFA salt and that the study ended prematurely.[1] A registry entry without results does not establish effectiveness or safety, and it cannot resolve the identity of a current catalog material.
Current FDA context
FDA’s 2024 scientific review separated CJC-1295 without DAC from the DAC active moiety and evaluated five bulk drug substances. FDA stated that none had an applicable USP or National Formulary drug-substance monograph and none was a component of an FDA-approved drug. FDA recommended that the five forms not be added to the section 503A Bulks List.[1][10]
That recommendation should not be described as a final rule. FDA’s current safety-risk page lists CJC-1295 under bulk substances whose nominations were withdrawn. It states that compounded CJC-1295 may pose immunogenicity, peptide-impurity, and API-characterization concerns, identifies increased heart rate and a systemic vasodilatory reaction among associated serious adverse events, and says clinical data are limited.[9]
FDA’s substance database also warns that having a UNII does not imply approval.[2]
An exact-term Drugs@FDA search for “CJC-1295” returned no results on August 27, 2026.[11] Drugs@FDA states that it covers drugs and biological products approved for human use, except products in specified CBER categories. This is a scoped database result, not proof across every synonym or excluded category, and it should be read alongside FDA’s substance-specific review above.
Why the Serum Research products are not linked
The standalone catalog record says “CJC-1295 with DAC,” 5 mg, and lyophilized powder, but it does not publicly identify free base, acetate, or TFA; provide the complete modified sequence and expected mass; or expose a lot-linked certificate. Its visible certificate control did not lead to a document when reviewed.
The CJC/IPA blend record creates a second problem. It does not publicly state the amount of either component or say whether CJC-1295 means the DAC or no-DAC active moiety. Evidence for isolated CJC-1295 and isolated ipamorelin would still not establish their interaction, ratio, stability, or behavior in a premixed material.
Before either record can be linked, the documentation must establish:
- the complete CJC active-moiety identity and modified sequence;
- free base, acetate, TFA, or other counterion/form;
- expected molecular mass and amount basis;
- the current label, SKU, lot, and sample relationship;
- lot-linked identity, content, impurity, and stability results with method limits; and
- for the blend, both component amounts, the ratio, and a blend-specific analytical method.
Major evidence limitations
- DAC and no-DAC CJC-1295 are different active moieties.
- The exact DAC bulk form used in the human papers is unclear.
- Human studies measured pharmacokinetics and hormone endpoints, not a demonstrated patient benefit.
- Pulse frequency and magnitude did not significantly change in the pulsatility study.
- The only registered patient trial is terminated and has no posted results.
- Short healthy-volunteer studies cannot characterize long-term or uncommon effects.
- No cited study establishes the identity, content, formulation, impurity profile, or stability of a Serum Research catalog material.
Frequently asked questions
Are CJC-1295 with DAC and without DAC the same molecule?
No. The DAC active moiety contains an added albumin-binding modification that the no-DAC active moiety lacks.
What does DAC do in the research molecule?
The defining study used a maleimide-containing group designed to bind serum albumin. The albumin association was investigated as a way to extend persistence in the tested systems.[3]
Do long-duration CJC-1295 studies apply to no-DAC material?
No. The persistence and pharmacokinetic evidence belongs to the DAC active moiety and cannot be assigned automatically to no-DAC CJC-1295.
Did human studies show a clinical benefit?
No demonstrated patient benefit was established. The published human work involved healthy volunteers and focused on pharmacokinetics, growth hormone, IGF-I, pulsatility, or exploratory serum proteins.[5][6][7]
Is there a completed patient trial with posted results?
No. NCT00267527 is listed as terminated, and no results are posted.[8]
Does an FDA UNII mean CJC-1295 is approved?
No. FDA’s GSRS page expressly says UNII availability does not imply regulatory review or approval.[2]
Why is the CJC/IPA blend not linked?
Its CJC form and component amounts are not publicly specified, and separate component studies do not validate the identity, ratio, interaction, or stability of the mixture.
Primary and official sources
- FDA briefing document on CJC-1295-related bulk substances
- FDA GSRS/UNII record for CJC-1295, 62RC32V9N7
- Jetté et al., albumin-bioconjugate characterization, PMID 15817669
- Alba et al., GHRH-knockout mouse model, PMID 16822960
- Teichman et al., randomized healthy-volunteer studies, PMID 16352683
- Ionescu and Frohman, growth-hormone pulsatility study, PMID 17018654
- Sackmann-Sala et al., exploratory serum proteomics, PMID 19386527
- ClinicalTrials.gov NCT00267527
- FDA current compounding safety-risk page
- FDA December 2024 advisory-committee meeting page
- Drugs@FDA approved-drug database and stated scope