FDA advisers reject CJC-1295, AOD-9604 and thymosin alpha-1

Five weeks after rejecting ipamorelin and kisspeptin-10, FDA’s Pharmacy Compounding Advisory Committee met again on December 4, 2024 and voted against three more peptides nominated for the 503A bulks list: CJC-1295 in five forms, AOD-9604 in two forms, and thymosin alpha-1 in two forms. The final summary minutes were approved on February 21, 2025.

The votes

As at the October meeting, FDA proposed that each substance not be listed and asked members whether it should be placed on the list. The committee first agreed to vote on CJC-1295 forms one at a time (one member objected to a single group vote), to treat AOD-9604 as a group, and to vote on thymosin alpha-1 forms separately.

Vote totals differ by topic because the minutes list temporary voting members who joined for particular substances.

What members said

The minutes summarize the discussion briefly. On CJC-1295 free base, “one member commented on the lack of evidence for effectiveness.” On thymosin alpha-1, members who voted no “agreed there was no compelling evidence demonstrating clinical effectiveness and safety in the uses … under review.” Members who voted yes said the substance “should be accessible to patients as an option for use.”

Where these peptides stand now

The votes were advice, not rules. FDA’s Category 2 page, checked October 19, 2026, lists AOD-9604, CJC-1295 and thymosin alpha-1 among substances whose nominations were withdrawn. That page keeps FDA’s safety language. None of the three is on the 503A bulks list. Our FDA status by peptide table keeps the current position for each.

The contrast with 2026

The 2024 committee rejected every peptide on both of its agendas. In July 2026 a committee with eight new members voted in favor of six of seven, against the recommendation of FDA’s own reviewers (report). The Center for Science in the Public Interest has since asked FDA to reject those votes (report).