CJC-1295 Compounding Pharmacy: How to Choose a Peptide Compounder

Does an approved CJC-1295 product exist at all?

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 [4][10]. FDA describes two forms: a 29-amino-acid GHRH analogue, and CJC-1295 DAC, the same peptide carrying an extra maleimidopropionic acid-lysine unit at one end that lets it bind blood albumin and last far longer [4][10].

In December 2024 FDA looked for approved products containing any form of CJC-1295 in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Norway, Spain and the United Kingdom, and found none, and none authorized by the European Medicines Agency [4]. There is therefore no approved product and no approved dose [4].

What the federal bulk-substance lists say

State-licensed pharmacies and physicians work from FDA's list of bulk drug substances that may be compounded, and outsourcing facilities work from a separate list [1][2]. CJC-1295 is in none of the three categories on the first list and is not on the second [1][2]. It is not a component of an FDA-approved drug and has no USP monograph, so FDA's category 1 policy, which generally means no action against compounders of nominated substances that meet the stated conditions, does not reach it [1][2].

FDA's own reviewers proposed in December 2024 that none of the CJC-1295 forms be added to the pharmacy bulks list [6]. 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 [6].

A common misreading of FDA's safety page

CJC-1295 currently sits in the nominated-but-withdrawn table on FDA's page about bulk substances that may present significant safety risks. It was placed in category 2, then came off that table because the nominators withdrew their nominations; it never entered category 1 [7].

The concerns FDA posted remain on the page. It lists possible immunogenicity for certain routes of administration, impurity and characterization problems, and serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction [7].

Is CJC-1295 covered by the October 2026 federal peptide policy?

No. HHS's October 2026 draft enforcement-discretion policy names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [9]. CJC-1295 is not among them [9].

Five checks that actually apply to this peptide

1. What the label says it is for. FDA noted that CJC-1295 products sold online are mostly labeled research use only, including blends with ipamorelin and GHRPs, and that the peptide has also turned up in illicit sports use [4]. A research-use-only product is not an FDA-approved drug [4].

2. Which list entry the seller relies on. For CJC-1295 there is none to point to [1][2].

3. Whether the seller is an outsourcing facility. FDA publishes a weekly table of facilities registered as outsourcing facilities, including their most recent inspection, whether a Form 483 was issued, and whether a recall occurred [3]. Registration describes the facility, not permission to compound a particular substance, and CJC-1295 is not on the outsourcing facility bulks list [2].

4. What compounding generally promises, and does not. Compounded drugs are not FDA-approved, which means FDA does not verify their safety, effectiveness or quality before they are marketed, and poor compounding practice can produce contamination or a product with too much or too little active ingredient [5].

5. Who actually made the drug. FDA notes that people who buy compounded drugs online, including through telehealth platforms, may not know which compounder produced the drug, or whether that compounder meets quality standards and is properly licensed [5]. State boards of pharmacy hold day-to-day oversight of state-licensed pharmacies, while FDA conducts surveillance and for-cause inspections; outsourcing facilities are inspected by FDA on a risk-based schedule and must follow current good manufacturing practice [5].

What the human studies measured

FDA identified only three published human studies of CJC-1295, all of the DAC form and all in healthy volunteers (Teichman 2006, Ionescu and Frohman 2006, Sackmann-Sala 2009), and found no study of any form in people with a disease [4]. One trial in HIV-associated visceral obesity listed on ClinicalTrials.gov was terminated [4].

The Teichman 2006 work was two randomized, placebo-controlled, double-blind, ascending-dose trials of 28 and 49 days in healthy adults aged 21 to 61, with single doses in the first and two or three weekly or biweekly doses in the second; FDA counted 35 treated subjects and 7 on placebo in the first study [4]. 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, with an estimated half-life of 5.8 to 8.1 days; after multiple doses IGF-I stayed above baseline for up to 28 days [11].

Adverse events, as FDA summarized them: injection-site reactions in about 70% of treated subjects in study 1 and in all treated subjects in study 2; headache 63% versus 14% on placebo in study 1; flushing, warmth and transient low blood pressure in about 30% of treated subjects in study 1; transient diarrhea; and transient dizziness with low blood pressure in two subjects. Most events were more common at 125 or 250 micrograms per kilogram, and no serious adverse reactions were reported [4][11]. In the Ionescu and Frohman study, healthy men aged 20 to 40 given one dose of 60 or 90 micrograms per kilogram showed dose-dependent increases in heart rate and transient injection-site redness and tenderness, with no serious adverse events [4][12]. Growth hormone pulses remained present, but trough GH rose about 7.5-fold [12].

Separately, ConjuChem withdrew CJC-1295 DAC from clinical trials in 2006 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 two hours after an 11th weekly dose and that the treating 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 [4].

The doses used in those studies, roughly 30 to 250 micrograms per kilogram given as single subcutaneous injections or as two or three weekly or biweekly doses, are study doses and not recommendations; there is no approved dose [4][11].

What FDA says about long-term safety

FDA's view is that raising growth hormone and IGF-I carries the risks listed on approved growth hormone labels, such as glucose intolerance and diabetes, fluid retention and tumor growth concerns, and that the CJC-1295 human studies were short, small and mostly single-dose, leaving long-term safety unknown [4]. FDA's safety-risk page also says the available clinical data are limited [7].

What about athletes and testing?

WADA's 2026 Prohibited List names CJC-1295, and CJC-1293, in S2.2.4 as growth hormone-releasing hormone analogues, prohibited at all times in and out of competition, and the substance is also named in the 2027 List that takes effect January 1, 2027 [8][13].