Update
FDA advisory committee declines to recommend CJC-1295 for pharmacy compounding
Reported by Maciek Zaremba
At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee reviewed CJC-1295 — including its free-base, acetate, and DAC-linked forms — for potential addition to the 503A Positive Bulk Drug Substances List and voted against inclusion, citing nonclinical toxicity findings, immunogenicity risk, and an unresolved cardiac safety signal from a 2006 human trial that was terminated after a participant's death.
What changed
CJC-1295 now has a documented, unfavorable advisory-committee review specifically addressing its DAC and non-DAC forms — a different outcome than BPC-157 and TB-500 received at their own PCAC review.
What didn't change
CJC-1295 was already not FDA-approved for any use before this review, and remains so. The committee's vote is a recommendation, not a binding rule; it does not itself change compounding legality in any jurisdiction.