GH secretagogues

CJC-1295

US status
Nomination withdrawn
Class
GH secretagogues
Approved product
None
Route
None lawful

Regulatory record

September 2024
Removed from Category 2 after nominator withdrawal; not added to Category 1.

Every entry above is dated; the record is current as of the review date.

Definition

CJC-1295 is a modified GHRH(1–29) analogue engineered to bind serum albumin, which extends a half-life measured in minutes for native GHRH to several days; it is the long-acting member of the growth hormone secretagogue family. Its developer described it as a tetrasubstituted GRF(1–29) carrying a reactive lysine group that attaches to albumin after injection [3].

The molecule reached formal clinical study in the 2000s, which distinguishes it from most of the research-peptide market.

Evidence

In a randomized, placebo-controlled study in healthy adults, single injections of CJC-1295 raised growth hormone concentrations two- to ten-fold for six days or more and IGF-1 concentrations 1.5- to three-fold for up to eleven days, with an estimated half-life of 5.8 to 8.1 days [1]. Development did not continue to approval, and no efficacy trial in any indication followed.

The long half-life raised the question of whether the natural pulses of growth hormone survive. In the one study that measured them, in healthy young men a week after a single injection, pulse frequency and size were unchanged while the baseline between pulses rose 7.5-fold, lifting mean growth hormone by 46 percent and IGF-1 by 45 percent [2]. A phase 2 trial in adults with HIV-associated abdominal fat was terminated in 2006 without a stated reason or posted results [5], and the FDA has since cited serious adverse events associated with the compound, including increased heart rate and a systemic vasodilatory reaction [6].

Lawful access

CJC-1295 was removed from Category 2 of the interim 503A bulks list in September 2024 because its nominators withdrew, and it was not added to Category 1; it is on no list, and no lawful compounding route exists. It was not among the peptides reviewed at the July 2026 PCAC meeting.

Material sold online is research-use-only supply, outside pharmacy licensure and quality standards.

The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names CJC 1295 among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [7].

Supply

No lawful US supply route exists for this molecule today. Lawfully available alternatives are recorded in the molecule index; the regulatory record on this page tracks the rulemaking that could change this.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

References

  1. Teichman SL, Neale A, Lawrence B, et al. 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;91(3):799–805. PMID 16352683
  2. Ionescu M, Frohman LA. 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;91(12):4792–4797. PMID 17018654
  3. Jetté L, Léger R, Thibaudeau K, et al. 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. Endocrinology. 2005;146(7):3052–3058. PMID 15817669
  4. PubMed, National Library of Medicine, and ClinicalTrials.gov. Census run September 2026. "CJC-1295" OR "CJC 1295" OR "CJC1295" returns 33 indexed records, 21 carrying the Humans MeSH term and 2 under "clinical trial"[Publication Type], both read: the 2006 pharmacokinetic study in healthy adults and the 2006 pulsatility study in healthy men. The same names, or "modified GRF", combined with ipamorelin return 11 records and 0 under "clinical trial"[Publication Type]; all 11 were read by title and type: nine 2026 narrative articles and reviews on peptide use in sport, orthopedics, aging and aesthetics, one 2019 analysis of seized doping material and one 2013 equine doping-control method. The filter was proved live in the same run (aspirin 8,916 records; aspirin AND clopidogrel 1,412), the invalid tag clinicaltrial[pt] returned 0 for aspirin, and a deliberately invalid identifier errored. ClinicalTrials.gov, searched the same day, returns one CJC-1295 study and no study of the combination. Source
  5. ClinicalTrials.gov. NCT00267527: A multicenter, randomized, placebo-controlled, double-blind, phase 2 study to evaluate the efficacy and safety of CJC 1295 administered for 12 weeks in HIV infected patients with HIV associated visceral obesity. Sponsor ConjuChem; planned enrollment 120; start December 2005; status Terminated, completion September 2006; no reason for stopping and no results posted. Read September 2026. Source
  6. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Lists CJC-1295 among the substances previously in Category 2 whose nominations were withdrawn by the nominators, and states that FDA has identified serious adverse events associated with it, including increased heart rate and systemic vasodilatory reaction, and that available clinical data are limited. Content current as of April 22, 2026. Read September 2026. Source
  7. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. Source