Is CJC-1295 FDA-Approved? Its FDA and 503A Status in 2026

No. CJC-1295 is not an FDA-approved drug and never has been. No CJC-1295 product has gone through FDA’s approval pathway, and none appears in Drugs@FDA.

It is also on none of the three categories on FDA’s 503A list, which is still dated May 14, 2026. CJC-1295 was reported placed in Category 2, FDA’s significant-safety-risk category, in 2023, and reported removed in September 2024 after its nomination was withdrawn. It was not moved to Category 1, so being off the risk list did not put it on a permission list.

CJC-1295, sermorelin and tesamorelin all mimic growth-hormone-releasing hormone, and WADA files all three under S2.2.4 as GHRH analogues. Their regulatory histories are very different. Tesamorelin is approved and marketed as Egrifta. Sermorelin was approved as Geref and discontinued in 2008, and FDA determined that was not for safety reasons. CJC-1295 has never been part of an approved drug.

That difference matters beyond trivia. Federal compounding law treats ingredients of FDA-approved drugs differently from ingredients that were never approved. Sermorelin’s history gives it an argument that CJC-1295 does not have. Comparisons that treat the three as interchangeable "GH peptides" miss this.

CJC-1295 has more human data than many peptides, but it is a specific kind of data. A pharmacokinetic study published in 2006 showed that a single dose produced prolonged growth-hormone release, and short-term rises in GH and IGF-1 have been measured. That shows the molecule does what it was designed to do in the body.

It does not show a clinical benefit. No clinical-outcome trial of CJC-1295 has been completed, and the one outcome trial that was registered was terminated. On our grading scale that places it in the human-pilot tier: real human pharmacology, no established patient outcomes.