CJC-1295 Compounding Pharmacy Quality Red Flags to Avoid

What CJC-1295 is

CJC-1295 is an investigational long-acting analogue of growth hormone-releasing hormone (GHRH), developed by ConjuChem Biotechnologies of Montreal and first described in 2005 [1][8]. The DAC form carries an extra maleimidopropionic acid-lysine unit at the C-terminal end that lets it bind blood albumin, so its half-life is measured in days rather than minutes [1]. In a single-injection study the estimated half-life was 5.8 to 8.1 days [7].

Red flag 1: a claim that CJC-1295 is FDA-approved

In December 2024 FDA found no approved product containing any form of CJC-1295 in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Norway, Spain or the United Kingdom, and none authorized by the European Medicines Agency [1].

The comparison that gets muddled is sermorelin, a related GHRH peptide that really was once approved as Geref before it was withdrawn in 2009. CJC-1295 was never approved [1].

Red flag 2: a claim that CJC-1295 can be compounded under current FDA policy

CJC-1295 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026), and it is not on FDA's list for outsourcing facilities (updated March 21, 2025). It is not a component of an FDA-approved drug and has no USP monograph, so FDA's category 1 policy, which is generally no action against compounders that meet its conditions, does not apply to it [3][4].

In December 2024 FDA's reviewers proposed that none of the CJC-1295 forms be added to the pharmacy bulks list. On December 4, 2024 the Pharmacy Compounding Advisory Committee voted 0 yes and 13 no on CJC-1295 free base, 1 yes and 12 no on CJC-1295 acetate, and 0 yes and 13 no on each of the three DAC forms [5].

Red flag 3: a claim that the new federal peptide policy covers it

HHS's October 2026 draft enforcement-discretion policy names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. CJC-1295 is not among them [9].

Red flag 4: 'research use only' labeling

FDA noted that CJC-1295 products sold online are mostly labeled 'research use only', including blends with ipamorelin and other GHRPs, and that the peptide has also appeared in illicit sports use. Research-use-only products are not FDA-approved drugs [1].

Compounded drugs in general are not reviewed by FDA for safety, effectiveness or quality before they reach patients. In 2012, contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths in 20 states [10].

Red flag 5: safety claims that run past the human data

FDA identified only three published human studies of CJC-1295: Teichman 2006, Ionescu and Frohman 2006, and Sackmann-Sala 2009. All three tested the DAC form, all were in healthy volunteers, and none was in people with a disease. A trial in HIV-associated visceral obesity listed as NCT00267527 was terminated [1].

The Teichman 2006 trials were two randomized, placebo-controlled, double-blind, ascending-dose studies of 28 and 49 days in healthy adults aged 21 to 61. Injection-site reactions occurred in about 70% of treated subjects in study 1 and in all treated subjects in study 2; headache occurred in 63% versus 14% on placebo in study 1; flushing, warmth and transient low blood pressure occurred in about 30% of treated subjects in study 1; most events were more common at the higher doses of 125 or 250 micrograms/kg, and no serious adverse reactions were reported [1][7]. In the Ionescu and Frohman study of healthy men given one dose of 60 or 90 micrograms/kg, there were no serious adverse events, with dose-dependent increases in heart rate and transient injection-site redness and tenderness [1].

FDA's broader concern is that this class raises growth hormone and IGF-I, and that elevation carries the risks listed on approved growth hormone labels, such as glucose intolerance and diabetes, fluid retention and tumor growth concerns. The human studies were short, small and mostly single-dose, so long-term safety is unknown [1].

FDA also describes what happened in 2006: ConjuChem withdrew CJC-1295 DAC from clinical trials after a participant in a phase 2 trial in HIV lipodystrophy, which enrolled 192 people, died. FDA cites news reports that the person had chest discomfort 2 hours after an 11th weekly dose, that an ECG showed an acute heart attack, and that the attending physician's most likely explanation was undiagnosed coronary artery disease with plaque rupture. The data were never published, so a causal link is neither shown nor excluded [1].

Red flag 6: a 'USP-grade' or 'standard purity' claim

There is no USP monograph for CJC-1295 [3]. FDA's posted concerns about the peptide remain online: possible immunogenicity for certain routes of administration, impurity and characterization problems, serious adverse events including increased heart rate and systemic vasodilatory reaction, and the statement that available clinical data are limited [2].

CJC-1295 was in category 2 of FDA's safety-risk list but now sits in the 'nominated but withdrawn' table because the nominators withdrew their nominations; it is not in category 1 either. FDA's stated concerns remain on the page [2].

Red flag 7: a 'not a banned substance' claim

WADA's 2026 Prohibited List names CJC-1295 and CJC-1293 in section S2.2.4 as growth hormone-releasing hormone analogues, prohibited at all times in and out of competition, and classifies S2 substances as non-Specified Substances. It is named in the 2027 List as well [6][11].

Red flag 8: a dose chart or 'standard protocol'

There is no FDA-approved dose for CJC-1295 [1]. The doses used in the human studies of the DAC form in healthy adults were single subcutaneous injections of about 30 to 250 micrograms/kg, or two to three doses given weekly or every two weeks; these were study doses, not recommendations [1][7]. After a single injection, mean plasma GH rose 2- to 10-fold for 6 days or more and mean IGF-I rose 1.5- to 3-fold for 9 to 11 days [7]. No trial tested the version sold as 'CJC-1295 without DAC', and no trial showed a health benefit [1][7].