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peptide

CJC-1295 with DAC

A long-acting GHRH analogue that binds blood albumin after injection, tested in about 60 healthy volunteers in studies published 2006–2009; its only patient trial was stopped after a death, it was never approved, and an FDA advisory committee voted against allowing it in compounding.

Data refreshed 2026-09-24 · Based on 8 published references

Names

Also called: CJC-1295 DAC, DAC:GRF, CJC 1295, CJC-1295 with drug affinity complex

Regulatory (US)

FDA approval: none

503A compounding: unknown

Molecule

Formula: C165H269N47O46

MW: 3647.2 g/mol

CAS: 446262-90-4

PubChem entry

Sequence: Tyr-D-Ala-Asp-Ala-Ile-Phe-Thr-Gln-Ser-Tyr-Arg-Lys-Val-Leu-Ala-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Leu-Ser-Arg-Lys(ε-maleimidopropionyl)-NH2

Origin

Discovered by: Lucie Jetté, Dominique Bridon and colleagues, ConjuChem (Montreal)

Year: 2005

Developer: ConjuChem Biotechnologies

What it is

CJC-1295 with DAC is a lab-made version of the first 29 building blocks of growth hormone-releasing hormone (GHRH), the brain signal that tells the pituitary gland to release growth hormone. Four of those building blocks were swapped to make the chain harder for the body to break down, and a small chemical hook, called a Drug Affinity Complex or DAC, was added to one end. After injection the hook latches onto albumin, the most common protein in blood, which carries the peptide around for days instead of minutes.

In the published human studies, one injection raised growth hormone and IGF-1 (a hormone made mainly in the liver when growth hormone rises) for one to two weeks. It is not an approved medicine anywhere. A different peptide without the hook is often sold under the same name.

CJC-1295 (DAC:GRF) is [D-Ala2, Gln8, Ala15, Leu27]-hGRF(1-29) extended at the C-terminus by a lysine whose ε-amine carries a 3-maleimidopropionamide (MPA) group, with a C-terminal amide (C165H269N47O46, 3647.2 g/mol). The substitutions address known weak points of GRF(1-29): D-Ala2 resists dipeptidyl peptidase-IV cleavage of the Ala2–Asp3 bond, Gln8 replaces deamidation-prone Asn8, Ala15 (for Gly15) is associated with greater helicity, and Leu27 replaces an oxidation-prone methionine. The maleimide reacts with the free thiol of Cys34 on serum albumin, forming a covalent conjugate in vivo.

It acts as an agonist at the GHRH receptor, a Gs-coupled receptor on anterior-pituitary somatotrophs, raising GH synthesis and release; its effect therefore depends on a functioning pituitary. Estimated half-life in healthy adults was 5.8–8.1 days. FDA’s 2024 review treats the DAC and non-DAC peptides as two distinct active moieties and documents inconsistent naming, so material labelled “CJC-1295” may be either.

Who made it and when

The molecule came from ConjuChem, a biotechnology company in Montreal, Canada, that was working on ways to make short-lived peptide drugs last longer by attaching them to albumin. Its scientists described CJC-1295 in 2005, and human studies followed in 2005 and 2006, aimed at conditions where the pituitary still works but makes too little growth hormone.

In 2006 a mid-stage trial in people with HIV and excess abdominal fat was stopped after a participant died of a heart attack shortly after a weekly dose. Reports cited by the FDA say the attending doctor’s most likely explanation was undetected heart disease, but the trial was ended and its results were never published. No later clinical program has been registered.

Jetté et al. (Endocrinology 2005) synthesised three maleimido derivatives of hGRF(1-29), conjugated them to human serum albumin ex vivo, and selected CJC-1295 because it produced a four-fold larger GH AUC over two hours than hGRF(1-29) in rats and remained in plasma beyond 72 hours, bound to albumin. Alba et al. (2006) reported that once-daily dosing normalised growth in GHRH-knockout mice, while dosing every 48 or 72 hours did not fully do so.

ConjuChem’s Phase 2 study NCT00267527 (12 weeks, HIV-associated visceral obesity) started in December 2005. FDA’s 2024 briefing, citing contemporaneous reports, records 192 randomised participants, an acute myocardial infarction diagnosed about two hours after an 11th weekly dose and death about an hour later, the attending physician’s attribution to plaque rupture in pre-existing coronary artery disease, and termination of the study; it states ConjuChem withdrew CJC-1295 from clinical trials in 2006. No compound patent could be verified for this article, so none is listed.

What the data say

All published human data come from about 60 healthy volunteers, most of them men, who received one to four injections in three studies published in 2006 and 2009. One dose raised growth hormone two- to tenfold for six days or more and IGF-1 by one and a half to three times for more than a week. The natural rhythm of growth hormone pulses was kept, but the low points between pulses rose sharply.

Side effects were common: injection-site reactions in most people, headache, flushing with warmth and brief drops in blood pressure, diarrhoea and a faster heart rate. The only trial in patients was stopped after a death and never reported results. Nothing is known about long-term use, and no study has measured any effect on a disease.

Teichman et al. (JCEM 2006) ran two randomised, double-blind, placebo-controlled ascending-dose studies in healthy adults aged 21–61. After single subcutaneous doses of 30–250 µg/kg, mean GH rose 2- to 10-fold for 6 days or more and mean IGF-1 1.5- to 3-fold for 9–11 days; IGF-1 exceeded the normal range only at 250 µg/kg. With two or three weekly or biweekly doses, IGF-1 stayed above baseline for up to 28 days. In study 1, adverse events occurred in 33 of 35 active and 2 of 7 placebo recipients: injection-site reactions about 70%, headache 63% versus 14%, diarrhoea, and vasodilatory reactions about 30%. No serious adverse reactions were reported.

Ionescu and Frohman (JCEM 2006) gave 60 or 90 µg/kg once to 12 healthy men. Pulse frequency and amplitude were unchanged; trough GH rose 7.5-fold (P under 0.0001), mean GH 46% and IGF-1 45%, with a dose-dependent heart-rate increase. Across these two papers and Sackmann-Sala et al. (2009), FDA’s 2024 review counted 63 exposed subjects, 87% men and 73% given a single dose. No efficacy data in any patient population exist.

Regulatory picture

Approval: no medicine containing CJC-1295 has been approved by the FDA or, as far as could be found, any other regulator.

Compounding: in September 2023 the FDA placed “CJC-1295” in Category 2, its list of nominated substances that raise significant safety concerns. The nominators withdrew in 2024, which removed that listing, and the FDA then reviewed the substance itself. In December 2024 its advisory committee voted 13 to 0 against adding any form of the DAC peptide to the list of ingredients pharmacies may compound with. It is not on that list, and the FDA has said drugs compounded from it do not qualify for the compounding exemptions.

Sport: the World Anti-Doping Agency lists CJC-1295 as prohibited at all times.

Approval: none. No IND-stage program could be identified after ConjuChem’s 2006 withdrawal.

Compounding: FDA’s 503A category list dated 2023-09-29 added “CJC-1295” to Category 2; the list dated 2024-09-27 removed it because the nominations were withdrawn. FDA evaluated five bulk substances on its own initiative (CJC-1295 free base and acetate; DAC free base, acetate and trifluoroacetate) for growth hormone deficiency, as a 2,000 mcg/mL subcutaneous injection, and proposed that none be listed, citing characterisation and naming problems, immunogenicity risk, adverse events including increased heart rate and systemic vasodilatory reactions, and no efficacy data. On 2024-12-04 the committee voted 0–13 for each DAC form. FDA’s safety-risk page, updated 2026-04-22, lists CJC-1295 among substances withdrawn from Category 2. With no USP monograph, no approved-drug component and no 503A bulks listing, compounded products fail section 503A(b)(1)(A)(i), as a 2020 FDA warning letter stated; no final rule on the committee’s advice had been published, so this article records the compounding field as unknown.

Sport: WADA 2026 Prohibited List, S2.2.4 (GHRH and its analogues), names CJC-1295.

Doses reported in trials

Doses reported in studies, exactly as the cited trial reported them. They are not personal dosing instructions. Population, route and schedule matter more than the number.

TrialPhaseStatusPopulationDoseResult
ConjuChem Phase 2 in HIV-associated visceral obesity
NCT00267527
2Terminated (2006)Adults aged 18–65 with HIV on stable antiretroviral therapy and HIV-associated visceral obesity (BMI above 24 and below 30); 120 planned in the registry, 192 enrolled according to reports cited by FDARegistry: low-dose or high-dose CJC 1295 versus placebo for 12 weeks, no milligram dose stated. FDA's 2024 review, citing contemporaneous reports: once-weekly subcutaneous injections escalating over three weeks at 60, 90 then 120 mcg/kg (low) or 60, 120 then 240 mcg/kg (high), continued for nine further weeksAbout two hours after an 11th weekly dose one participant reported chest discomfort, an ECG confirmed acute myocardial infarction, and he died about an hour later; the attending physician's most likely explanation was pre-existing coronary artery disease. The study was terminated and no results were published.
Single ascending-dose study in healthy adults
Teichman 2006, study 1
Not stated (unregistered ascending-dose study)Completed, published 200642 healthy adults aged 21–61 (35 active, 7 placebo), two US sitesSingle subcutaneous injection of 30, 60, 125 or 250 mcg/kg, or placeboMean GH up 2- to 10-fold for 6 days or more and mean IGF-1 up 1.5- to 3-fold for 9–11 days; estimated half-life 5.8–8.1 days; adverse events in 33 of 35 on drug versus 2 of 7 on placebo, no serious reactions
Multiple-dose study in healthy adults
Teichman 2006, study 2
Not stated (unregistered ascending-dose study)Completed, published 200624 healthy adults in four groups of six (one placebo per group)Subcutaneous 30 or 60 mcg/kg on days 0 and 14, or 30 or 20 mcg/kg on days 0, 7 and 14Mean IGF-1 stayed above baseline for up to 28 days, with a cumulative effect after repeated doses; flushing in 40% after low and 100% after high doses
GH pulsatility study
Ionescu and Frohman 2006
Not stated (unregistered physiology study)Completed, published 200612 healthy men aged 20–40Single subcutaneous injection of 60 mcg/kg (n=4) or 90 mcg/kg (n=8)One week later, pulse frequency and size unchanged; trough GH up 7.5-fold, mean GH up 46%, IGF-1 up 45%; dose-dependent rise in heart rate

Enforcement history

Reported side effects

Interactions

Not catalogued yet.

Contraindications

Not catalogued yet.

Storage

No approved product exists, so there is no label storage data.

Product characteristics

Form: Synthetic 30-residue peptide carrying a reactive maleimide group; the published studies used subcutaneous injection

Stability: Designed to bond covalently to albumin after injection; estimated half-life 5.8–8.1 days in healthy adults

Compound information

The maleimide group reacts with free thiols, which is how it attaches to albumin Cys34. FDA's 2024 review distinguishes three salt forms of the DAC peptide (free base, acetate, trifluoroacetate) and notes that the trifluoroacetate salt was used in a nonclinical study.

References

This page summarises the published sources below. PeptideBasics101 does no original research. Trial doses and results are reported as the cited study or label reported them. Sources can themselves be wrong or superseded; if you find a statement here that does not match its source, please tell us through our corrections process. Sources were last checked on 2026-09-24.

  1. FDA briefing document: CJC-1295-related bulk drug substances, Pharmacy Compounding Advisory Committee, December 4, 2024 (fda.gov)
  2. FDA: minutes of the December 4, 2024 Pharmacy Compounding Advisory Committee meeting (fda.gov)
  3. FDA: certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 and withdrawn substances) (fda.gov)
  4. Jetté L et al. hGRF1-29-albumin bioconjugates activate the GRF receptor: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology 2005 (pubmed.ncbi.nlm.nih.gov)
  5. Teichman SL et al. Prolonged stimulation of GH and IGF-I secretion by CJC-1295 in healthy adults. J Clin Endocrinol Metab 2006 (pubmed.ncbi.nlm.nih.gov)
  6. Ionescu M, Frohman LA. Pulsatile secretion of GH persists during continuous stimulation by CJC-1295. J Clin Endocrinol Metab 2006 (pubmed.ncbi.nlm.nih.gov)
  7. ClinicalTrials.gov: NCT00267527, CJC 1295 in HIV patients with visceral obesity (clinicaltrials.gov)
  8. PubChem: CJC-1295 (CID 91971820) (pubchem.ncbi.nlm.nih.gov)

Clinical trial entries in the table above link to their ClinicalTrials.gov registry records. Spotted an error? See corrections.

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