CJC-1295 with DAC Research

CJC-1295 with DAC is a long-acting analogue of growth hormone releasing factor, supplied as a research chemical and not for human consumption. It holds no marketing authorization anywhere, and no application has ever been filed, so it has never been refused approval ^[9a].

Molecular identity

The backbone is human GRF(1-29) with four substitutions, at positions 2, 8, 15 and 27 ^[1]. An added lysine carries an N-epsilon-3-maleimidopropionamide group, the drug affinity complex or DAC, which reacts with the free thiol of cysteine-34 on albumin ^[1]. This is a growth hormone releasing hormone (GHRH) receptor agonist, not a growth hormone analogue.

CAS 446262-90-4 resolves to PubChem CID 91971820, C165H269N47O46, molecular weight 3647.2, the DAC-bearing molecule ^[2]. The widely circulated 863288-34-0 resolves instead to CID 56841945 at 3367.9, the DAC-free peptide sold as modified GRF(1-29) ^[2]. Every figure below belongs to the DAC form alone, and the DAC-free peptide is essentially uncharacterized in humans ^[17]. Material labeled CJC-1295 with DAC and material labeled without DAC are two different molecules.

Human evidence

Three published studies have given the compound to humans, 63 healthy volunteers, 73 percent receiving a single administration ^[9a]. The third analyzed a subset of the second cohort, not an independent third group ^[5][9a]. None had a disease or condition, and no study ever has ^[9a].

The estimated half-life was 5.8 to 8.1 days, and single administration raised mean plasma growth hormone 2- to 10-fold for 6 days or more ^[3]. Mean IGF-1 rose 1.5- to 3-fold for 9 to 11 days, staying above baseline for up to 28 days after repeated administration ^[3]. No serious adverse reactions were reported ^[3]. Injection-site reactions affected roughly 70 percent of recipients, and systemic vasodilatory reactions with transient hypotension 30 percent, against none on placebo ^[3][9a].

A second study found pulsatility preserved, pulse frequency and magnitude unaltered, while trough growth hormone rose 7.5-fold ^[4]. IGF-1 rose 45 percent and correlated with no measured parameter of growth hormone secretion, though the authors concluded the trough rise drove it ^[4]. A third report analyzed serum proteins in 11 men from that same cohort ^[5]. Nothing downstream of this pharmacology has been demonstrated in a human.

The single registered trial

NCT00267527, the only interventional trial for this compound on the US and EU registers, was a randomized, double-blind, placebo-controlled Phase 2 study in adults with HIV-associated visceral obesity ^[7][12]. It is recorded as TERMINATED ^[7]. The European register holds the same study as EudraCT 2005-003797-25, ended "Prematurely" ^[8]. Neither says why: the ClinicalTrials.gov record has no why-stopped field and no posted results ^[7]. Its enrollment figure of 120 was a target never revised ^[7]. The number enrolled at the halt was 192, which does not come from the registry ^[9a][11].

The death, and where it comes from

The sponsor stopped the study on 17 July 2006 after a participant at an Argentine site died ^[11]. The fullest account reaches the public record through two December 2024 docket documents, an FDA briefing document and a submission by compounding interests ^[9a][9b]. Both report chest discomfort two hours after an eleventh weekly injection, an ECG confirming acute myocardial infarction, and death approximately one hour later ^[9a][9b]. Each carries the attending physician's conclusion in that same paragraph, that his most likely explanation was asymptomatic coronary artery disease with plaque rupture and occlusion ^[9a][9b].

Both halves come from the same anecdotal chain: the briefing document's footnote to that paragraph reads "See the following two internet anecdotal reports" ^[9a]. The contemporaneous trade-press item carries the timing only as an unconfirmed anecdotal report, with no ECG and no physician conclusion ^[11]. Timing and attribution therefore stand or fall together, and neither can be reported as fact while the other is reported as opinion.

The docket submission elsewhere miscalls CJC-1295 a synthetic analogue of growth hormone, which is wrong ^[9b]. The briefing document reports FAERS and CAERS searched through 2024, with no case reports for CJC-1295 ^[9a]. No peer-reviewed account of this trial or this death exists, causality was never adjudicated, and no sponsor has registered a trial since ^[9a][12].

Animal findings and regulatory status

Repeat-dose studies in rats and dogs reported injection-site hemorrhage, inflammation and necrosis alongside reduced red cell measures ^[9a]. In GHRH-knockout mice the compound produced somatotroph proliferation, and no two-year carcinogenicity study of any form of CJC-1295 exists ^[6][9a]. These are animal findings, and none has been shown in a human.

On 4 December 2024 an FDA advisory committee voted 0 to 13 against the DAC forms on the 503A bulks list ^[10]. That vote concerns pharmacy compounding eligibility and is advisory, not a safety adjudication ^[10].

The tesamorelin comparison, and what it does not transfer

Tesamorelin is a GHRH(1-44) analogue acting at the same pituitary receptor ^[13][16]. Its FDA approval, granted on 10 November 2010, still stands for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy ^[13]. Its label limits that further: long-term cardiovascular safety is not established, and it is not indicated for weight loss because its effect is weight neutral ^[14]. It never obtained a European authorization: the applicant, Ferrer Internacional, S.A., withdrew the application under CHMP review, and no refusal decision was issued ^[15].

The shared receptor is where the resemblance ends. Tesamorelin's mean elimination half-life is formulation-specific, 8 minutes and 11 minutes, and it is administered once daily in its label ^[14][16]. CJC-1295 with DAC has an estimated half-life of 5.8 to 8.1 days, with trough growth hormone raised 7.5-fold ^[3][4]. Same receptor, exposures orders of magnitude apart in duration. GHRH analogue names a receptor target, not a duration of action.

The approval belongs to the molecule tesamorelin and to one indication. It is not a family credential and must never be written as one. The honest contrast is not that tesamorelin works and the others might too. It is that tesamorelin is the only one of the nine that has been through the process that would let anyone know.

GHRP-2 is reported to be used in Japan as a diagnostic agent for growth hormone deficiency testing, unverified against any primary regulator ^[18]. The cited source records only that Japanese approval was pending in 2004 ^[18]. A diagnostic provocative test is not a therapeutic authorization, and is not comparable to tesamorelin's.

Frequently Asked Questions

Which CAS number identifies the DAC form? CAS 446262-90-4 resolves to PubChem CID 91971820 at molecular weight 3647.2, the DAC-bearing molecule ^[2]. The widely circulated 863288-34-0 resolves to CID 56841945 at 3367.9, a different molecule, and the pharmacokinetic data apply only to the DAC form ^[2][3].

What is known about the death in the terminated trial? Two December 2024 docket documents report chest discomfort two hours after an eleventh weekly injection, an ECG-confirmed infarction, and death about an hour later ^[9a][9b]. Both documents carry the attending physician's attribution in that same paragraph, to asymptomatic coronary artery disease with plaque rupture ^[9a][9b]. Both halves rest on that one anecdotal chain, and neither registry records a reason for stopping ^[7][8][9a].

References

1. 1

   Jetté L, et al. Endocrinology 2005. PMID 15817669. DOI 10.1210/en.2004-1286. Animal. COI: all authors were employees of the sponsor, ConjuChem Inc.
2. 2

   PubChem compound records CID 91971820 (CAS 446262-90-4) and CID 56841945 (CAS 863288-34-0). Database records, no PMID.
3. 3

   Teichman SL, et al. J Clin Endocrinol Metab 2006. PMID 16352683. DOI 10.1210/jc.2005-1536. Human. COI: sponsor-funded, with ConjuChem-affiliated co-authors; no independent replication exists.
4. 4

   Ionescu M, Frohman LA. J Clin Endocrinol Metab 2006. PMID 17018654. DOI 10.1210/jc.2006-1702. Human. COI: senior author also co-authored the sponsor-run pharmacokinetic trial.
5. 5

   Sackmann-Sala L, et al. Growth Horm IGF Res 2009. PMID 19386527. DOI 10.1016/j.ghir.2009.03.001. Human. COI: cohort derived from the sponsor-adjacent study above.
6. 6

   Alba M, et al. Am J Physiol Endocrinol Metab 2006. PMID 16822960. DOI 10.1152/ajpendo.00201.2006. Animal. COI: ConjuChem-affiliated co-authors.
7. 7

   NCT00267527, ClinicalTrials.gov registry record, lead sponsor ConjuChem, last updated 12 October 2006. Sponsor-authored, not independently verified.
8. 8

   EudraCT 2005-003797-25, European Union Clinical Trials Register, German authorization 9 December 2005. Sponsor-authored.
9. 9a

   FDA Briefing Document for CJC-1295-Related Bulk Drug Substances, Center for Drug Evaluation and Research, Pharmacy Compounding Advisory Committee meeting 4 December 2024, 72 pages, docket FDA-2024-N-4777, fda.gov/media/183819/download. Regulatory document, not peer-reviewed. FDA writes "The report states that" of the death account and footnotes that paragraph to two internet anecdotal reports.
10. 9b

    Docket submission FDA-2024-N-4777-0002, attachment 7, December 2024. Not peer-reviewed. Submitted by compounding interests; promotional in tone, and miscalls CJC-1295 a synthetic analogue of growth hormone.
11. 10

    FDA Pharmacy Compounding Advisory Committee, official meeting minutes, 4 December 2024. Regulatory record.
12. 11

    Bernard EJ. "Lipodystrophy study halted after patient death." aidsmap (NAM Publications), 31 July 2006. Trade press, not peer-reviewed; its account of the death is explicitly anecdotal.
13. 12

    ClinicalTrials.gov and EU Clinical Trials Register searches for CJC-1295, re-run 27 August 2026. Covers the US and EU registers only.
14. 13

    FDA Drugs@FDA record for tesamorelin, BLA 022505. Original approval 10 November 2010; labels effective 29 July 2026; most recent supplement approved 25 March 2025.
15. 14

    FDA approved prescribing information for tesamorelin, Limitations of Use and section 12.3, label effective 29 July 2026. Mean elimination half-life is formulation-specific, 8 minutes and 11 minutes.
16. 15

    European Medicines Agency press release EMA/431454/2012. Ferrer Internacional, S.A. notified withdrawal on 21 June 2012; EMA announced it on 26 June 2012.
17. 16

    Falutz J, et al. J Clin Endocrinol Metab 2010. PMID 20554713. DOI 10.1210/jc.2010-0490. Human. COI: sponsor-affiliated co-authors, company-sponsored trial.
18. 17

    Dominikowski A, et al. Front Endocrinol (Lausanne) 2026. PMID 42395176. DOI 10.3389/fendo.2026.1822475. Narrative review. Cited here only for the uncharacterized status of the DAC-free peptide; it does not mention the terminated trial, the termination or the death. COI: authors declared none.
19. 18

    Adis drug profile, Drugs R D 2004. PMID 15230633. Records the Japanese diagnostic agent as awaiting approval at the time of writing; not confirmed against a primary regulator.